Publications

Since 1993, Clinical Trials Inc. (CTI) and Dr. Victor Biton have been instrumental in testing and developing new potential medications. CTI has hosted hundreds of clinical trials and assisted in bringing many important medications to market. Below is a list of Dr. Victor Biton’s articles, abstracts, and clinical studies experience.

Articles/Chapters

Biton V. The Treatment of Epilepsy (Shorvon S, Perucca E, Engel J, eds.). 4th ed., John Wiley & Sons, Ltd./Blackwell                              Publishing, 2016 ( chapter 47: Rufinamide; 615-627).

Sachdeo R, Partiot A, Biton V, Rosenfeld WE, Nohria V, Tompson D, DeRossett 5, Porter RJ. A novel design for a dose                            finding, safety, and drug interaction study of an antiepileptic drug (retigabine) in early clinical development.                      Int J Clin Pharmacol Ther; 2014; 52(6 ): 509-518.

Biton V, Gil-Nagel A, Brodie M, DeRossett S, and Nohria V. Safety and tolerability of different titration rates of retigabine                      (ezogabine) in patients with partial-onset seizures. Epilepsy Res; 2013; 107( 1 ): 138-145.

Biton V, Berkovic S, Abou-Khalil B, Sperling M, Johnson M, and Lu S. Brivaracetam as adjunctive treatment for                                        uncontrolled partial epilepsy in adults: A phase 111 randomized, double-blind, placebo-controlled trial.                                Epilepsia ( online) Nov 8, 2013.

Klein P, Biton V, Dilley D, Barnes M, Schiemann J, Lu S. Safety and tolerability of adjunctive brivaracetam as intravenous                       infusion or bolus in patients with epilepsy. Epilepsia (online) Nov 81 2013.

Biton V, Shneker B, Naritoku D, Hammer A, Vuong A, Caldwell P, and Messenheimer J. Long-term tolerability and safety                          of lamotrigine extended-release: Pooled analysis of three clinical trials. Clinical Drug Investigation 2013;                            33(5): 359-364.

 Biton V. Lacosamide for the Treatment of Partial-Onset Seizures. Expert Rev. Neurother 2012; 12(6): 645-655.

Sandercock D, Cramer M, Biton V, Cowles VE. A Gastroretentive Gabapentin Formulation for the Treatment of Painful                               Diabetic Peripheral Neuropathy: Efficacy and Tolerability in a Double­Blind, Randomized, Controlled Clinical                         Trial. Diabetes Res Clin Pract 2012; Apr 10. (Epub ahead of print] 

Biton V, Krauss G, Vasquez-Santana B, Bibbiani F, Mann A, Perdomo C, and Narurkar M. A
                        Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study of Rufinamide as Adjunctive Therapy                          for Refractory Partial-Onset Seizures. Epilepsia 2011; 52(2): 234- 242.(Published Online: October 1, 2010.                          (DOI: 10.1111/j.1528-1167.2009.02729.x)].

Chung S, Sperling M, Biton V, Krauss G, Hebert D, Rudd G, and Doty P. Lacosamide as Adjunctive Therapy for Partial-                                Onset Seizures: A Randomized Controlled Trial. Epilepsia 2010; 51(6): 958-967 (doi: 10.1111/j.1528-                                  1167.2009.02496.x).

Biton V. The Treatment of Epilepsy (Shorvon S, Perucca E, Engel J, eds.). 3rd ed., Blackwell Publishing, 2009 ( chapter                               51: Rufinamide; 647-657).

Sandercock D, Cramer M, Wu J, Chiang Y, Biton V, Heritier M. Gabapentin Extended Release for the Treatment of Painful                            Diabetic Peripheral Neuropathy: Efficacy and Tolerability in a Double-blind, Randomized, Controlled                                      Clinical Trial. Diabetes Care (online) Feb 2009; 32 (2). 

Biton V. Lamotrigine for Pediatric Patients with Epilepsy. Pediatric Health 2008; 2 (2): 125-134.

Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous Lacosamide as Replacement for                                 Oral Lacosamide in Patients with Partial-Onset Seizures. Epilepsia 2008; 49(3): 418-424.

Biton, V. Lacosamide for the Treatment of Diabetic Neuropathic Pain. Expert Review of Neurotherapeutics 2008; 8(11):                               1649-1660.

Rauck RL, Shaibani A, Biton V, Simpson J, Koch B. Lacosamide in Painful Diabetic Neuropathy: A Phase 2 Double-Blind                                Placebo-Controlled Study. Clinical Journal of Pain 2007; 23(2): 150-158.

Biton, V. Clinical Pharmacology and Mechanism of Action of Zonisamide. Clinical Neuropharmacology 2007; 30 (4):                                    230- 240.

Biton V. Pharmacokinetics, Toxicology, and Safety of Lamotrigine in Epilepsy. Expert Opin Drug Metab Toxicol 2006;                                   2(6):1009- 1018.

Blum D, Meador K, Biton V, Fakhoury T, Shneker B, Chung S, Mills K, Hammer A, lsojarvi J. Cognitive Effects of                                               Lamotrigine Compared with Topiramate in Patients with Epilepsy. Neurology 2006; 67(3): 400-406.

Biton V. Weight Change and Antiepileptic Drugs: Health Issues and Criteria for Appropriate Selection of an Antiepileptic                             Agent. Neurologist 2006; 12(3): 163-167.

Biton V, Sackellares JC, Vuong A, Hammer AE, Barrett PS, Messenheimer, JA. Double-Blind, Placebo-Controlled Study of                              Lamotrigine in Primary Generalized Tonic-Clonic Seizures. Neurology 2005; 65: 1737-1743.

Biton V, Bourgeois BFD. Topiramate in Patients with Juvenile Myoclonic Epilepsy. Archives of Neurology 2005; 62( 11 ):                                1705-1708.

Sale ME, Natarajan S, Biton V, Vuong A, Hammer AE, Messenheimer JA, Blum D. A Dosing Algorithm for Converting from                              Valproate Monotherapy to Lamotrigine Monotherapy in Patients with Epilepsy. Epilepsy and Behavior                                  2005; 6: 63-70.

Biton V. Zonisamide: New Antiepileptic Agent with Multiple Mechanisms of Action. Expert Rev Neurotherapeutics 2004;                              4( 6 ): 935-943.

Biton V. Antiepileptic Drugs and Weight Gain. SYCP Epilepsy 2003; 10(2): 3-6.

Sommerville KW, Dutta S, Biton V, Zhang Y, Cloyd JC, Uthman B. Bioavailability of a Divalproex Extended-Release                                          Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-                                        Inducing Antiepileptic Drugs. C/in Drug Invest 2003; 23(10): 661- 670.

Leppik IE, Biton V, Sander JW, Wieser HG. Levetiracetam and Partial Seizure Subtypes: Pooled Data From Three                                            Randomized, Placebo-Controlled Trials. Epilepsia 2003; 44 Suppl.12: 1585-1587.

Biton V. Effect of Antipeileptic Drugs on Bodyweight: Overview and Clinical Implications for the Treatment of Epilepsy.                                 CNS Drugs 2003; 17(11): 781-791.

Biton V, Levisohn P, Hoyler S, Vuong A, Hammer AE. Lamotrigine versus Valproate Monotherapy Associated Weight                                       Change in Adolescents with Epilepsy: Results from a Post Hoc Analysis of a Randomized, Double-Blind                               Clinical Trial. J Child Neuro/ 2003; 18 (2): 133-139.

Gilliam FG, Veloso F, Bomhof MAM, Gazda SK, Biton V, Ter Bruggen JP, Neto W, Bailey C, Pledger G, Wu S-C, Topiramate                                  EPMN 104 Study Group. A Dose-Comparison Trial of Topiramate as Monotherapy in Recently                                                Diagnosed Partial Epilepsy. Neurology 2003; 60: 196-202.

Biton V. Levetiracetam: Adverse Effects. In: Levy RH, Mattson RH, Meldrum BS, Perucca E, eds. Antiepileptic Drugs, 5th                                   ed. Philadelphia: Lippincott Williams & Wilkins, 2002: 442-447.

Biton V, Mirza W, Montouris G, Vuong A, Hammer AE, Barrett PS. Weight Change Associated with Valproate and                                               Lamotrigine Monotherapy in Patients with Epilepsy. Neurology 2001; 56: 172- 177.

Biton V, Edwards K, Montouris G, Sackellares J, Harden C, Kamin M. A Comparison of Titration Rates on Tolerability and                                 Efficacy of Topiramate Initiated as Adjunctive Therapy. Ann Pharmacother 2001; 35: 173-179.

Apfel SC, Schwartz S, Adornato BT, Freeman R, Biton V, Rendell M, Vinik A, Guiliani M, Stevens JC, Barbano R, Dyck P J,                                   rhNGF Clinical Investigator Group. Efficacy and Safety of Recombinant Human Nerve Growth Factor                                   in Patients with Diabetic Polyneuroapthy. JAMA 2000; 284: 2215-2221.

Cereghino JJ, Biton V, Abou-Khalil B, Dreifuss F, Gauer U, Leppik I. Levetiracetam for Partial Seizures: Results of a                                           Double-Blind, Randomized Clinical Trial. Neurology 2000; 55: 236- 242.

Biton V, Montouris GD, Ritter F, Riviello JJ, Reife R, Lim P, Pledger G. A Randomized, Placebo­ Controlled Study of                                                Topiramate in Primary Generalized Tonic-Clonic Seizures. Neurology 1999; 52: 1330-1337.

Honeycutt J, Boop FA, Biton V, Sharp GB, Griebel ML, Galbraith R. Results of Temporal Lobectomy for the Treatment of                                     Partial Complex Epilepsy. J Ark Med Society 1994; 91(7): 329-333. 

Biton V, Gates J, De Padua E. Prolonged Postictal Encephalopathy. Neurology 1990; 40: 963-966.

Biton V, Gates J, Ritter F, Loewenson R. Adjunctive Therapy for Intractable Epilepsy with Ethotoin. Epilepsia 1990 Jul-                                        Aug; 31(4): 433-437.

Melamed E, Biton V, Zelig 0. Episodic Unresponsiveness to Single Doses of L-Dopa in Parkinsonian Fluctuators.                                                  Neurology 1986; 36: 100-103.

Melamed E, Biton V, Zelig 0. Delayed Onset of Responses to Single Doses of L-Dopa in Parkinsonian Fluctuators in Long                                    Term L-Dopa Therapy. Clin Neuropharmaco/ 1986; 9(2): 182-188.

Gottlieb D, Fields S, Biton V, Gomori M, Kidron D, Melamed E. Clinical Roentgenological Study of Degenerative                                                      Spinocerebellar Diseases. Harefuah (Hebrew) 1986; 111: 165-167.

Biton V, Gomori JM, Gottlieb D, Melamed E. Superior Sagittal Sinus thrombosis: Clinical Picture and Computed                                                    Tomographic Findings. Harefuah (Hebrew) 1985; 108: 3-5.

Mathetias O, Soomer H, Biton V. Central Auditory Tests in Multiple Sclerosis. Acta Oto/aryngol 1985; 99: 369-376.

Biton V, Melamed E. Coexistence of Severe Parkinsonism and Tardive Dyskinesia as Side Effects of Neuroleptic                                                   Therapy. J Clin Psychiatry 1984; 45: 28-30.

Abstracts

Bramson C, Herrmann D, Biton V, Carey W, Keller D, Brown M, West C, Verburg K, and Dyck P. 
                    Efficacy and Safety of Subcutaneous Tanezumab in Patients With Pain Related to Diabetic Peripheral                                  Neuropathy (NCT01087203). (Presented at the 32nd Annual Meeting of the American Pain Society, May 8-                        10, 2013, Tampa, Florida)

Fain R, Yang H, Williams B, Zhou S, Laurenza A, and Biton V. Efficacy and Safety of Perampanel in Patients With                                    Neurologic & Psychiatric Comorbidities: Post-Hoc Analysis of Phase Ill Epilepsy Trials. (Poster presentation                      at AES, 2013, Washington DC) 

Biton V, Krauss G, Blum D, Sousa R, and Grinnell T. Efficacy of eslicarbazepine acetate in patients with refractory partial-                      onset seizures: a pooled analysis of three Phase 111 controlled studies. (Poster presentation at AES, 2013,                      Washington DC)

Krauss G, Biton V, Harvey J, Blum D, Sousa R, and Grinnell T. Adverse event profile of eslicarbazepine acetate according                       to dose titration in Phase Ill controlled studies of patients with refractory partial-onset seizures. (Poster                             presentation at AES, 2013, Washington DC)

Krauss G, Yang J, Biton V, Klapper J, Bar M, Rektor I. Determination of Maximum Tolerated Dose (MTD), Safety, Efficacy,                       and Pharmacokinetics (PK) of Perampanel, a Selective AMPA Receptor Antagonist, as Adjunctive Therapy                         in Subjects with Refractory Partial Seizures. (Abstract presented at the 62nd Annual Meeting of the                                     American Epilepsy Society 2008) 

Jatuzis D, Biton V, Ben-Menachem E, Abou-Khalil B, Doty P, Rudd GD. Evaluation of the Effect of Oral Lacosamide on                             Concomitant AED Plasma Concentrations in Patients with Partial Seizures. Epilepsia 2005; 46 Suppl.8: 170. 

Lesser RP, Biton V, Sackellares JC, Van Ness PC, Perdomo C, Arroyo S. Efficacy and Safety of Rufinamide Monotherapy                          for the Treatment of Patients with Refractory Partial Seizures. Epilepsia 2005; 46 Suppl.8: 177-178. 

Rosenfeld W, Biton V, Mameniskiene R, Vaiciene N, Whitesides J, Schiltmeyer B, Sommerville K. Pharmacokinetics and                          Safety of Intravenous Lacosamide Administered as Replacement for Adjunctive Oral Lacosamide in                                    Patients with Partial-Onset Seizures. Epilepsia 2005; 46 Suppl.8: 184. 

Sachdeo R, Porter R, Biton V, Rosenfeld W, Alves W, Nohria V. Dose Finding Study of Retigabine (A Novel AED) in                                       Patients with Epilepsy. Epilepsia 2005; 46 Suppl.8: 185. 

Biton V, Sachdeo R, Rosenfeld W, Schachter S, Perdomo C, Arroyo S. Efficacy and Safety of Adjunctive Rufinamide in                               Patients with Inadequately Controlled Primary Generalized Tonic­Clonic Seizures. Epilepsia 2005; 46                                   Suppl.8: 206. 

Biton V, Vuong A, Kerls S, Hammer A, Messenheimer J. Onset of Efficacy with Lamotrigine in Primary Generalized Tonic-                         Clonic Seizures (PGTCS): A Randomized, Placebo-Controlled Study. Epilepsia 2005; 46 Suppl.8: 206. 

Todorov A, Biton V, Krauss GL, Perdomo C, Arroyo 5. Efficacy and Safety of High- Versus Low-Dose Rufinamide                                          Monotherapy in Patients with Inadequately Controlled Partial Seizures. Epilepsia 2005; 46 Suppl.8: 218-                              219. 

Biton V, Rosenfeld W, Mameniskiene R, Vaiciene N, Whitesides J, Sommerville K. Safety and Tolerability of Intravenous                             Lacosamide as Replacement for Oral Lacosamide in Subjects with Partial-Onset Seizures. Epilepsia                                   2005; 46 Suppl.6: 121. 

Ben-Menachem E, Biton V, Jatuzis D, Abou-Khalil B, Doty P, Rudd D, S.P. 667 Study Group. Efficacy and Safety of                                          Adjunctive Oral Lacosamide for the Treatment of Partial Onset Seizures in Patients with Epilepsy.                                        Epilepsia 2005; 46 Suppl.6: 57. 

Biton V, Groenke DA, Hammer AE, Kustra RP, Messenheimer JA, Winter P. Evaluation and Comparison of Seizure Control                             During Escalation of Lamotrigine, Valproic Acid, Carbamazepine and Phenytoin as Initial Monotherapy                               in Patients with Epilepsy. Eur J Neural 2003; 10(1): 141. 

Biton V, Whitesides J, Doty P, Sommerville K. Safety and Efficacy of 5PM 927 during the Initial Phase of an Extension                                 Trial in Subjects with Partial Seizures. Epilepsia 2003; 44 Suppl.9: 259. 

Biton V, Bebin ME. Multicenter, Open-Label Assessment of the Efficacy and Safety of Zonisamide as Adjunctive Therapy                              for Primary Generalized Epilepsy. Epilepsia 2002; 43 Suppl.7: 2.180. 

Biton V, Blum D, Groenke D, Hammer A, Messenheimer J. Evaluation and Comparison of Seizure Control During                                              Escalation of Lamotrigine, Valproic Acid, Carbamazepine and Phenytoin as Initial Monotherapy in                                        Patients with Epilepsy. Epilepsia 2002; 43 Suppl.7: 2.183 

Biton V. Weight Change Associated with Valproate And Lamotrigine Monotherapy In Patients with Epilepsy. [Letter]                                      Neurology 2001; 57(3): 565-566. 

Montouris G, Biton V, Rosenfeld W, YTC/YTCE Study Group. Nonfocal Generalized Tonic-Clonic Seizures: Response                                     During Long-Term Treatment. Epilepsia 2000; 41 Suppl.1: S77-S81. 

Mirza W, Biton V, Barrett P, Vuong A, Hammer A. Weight Gain Associated with Valproate Monotherapy in Patients with                                  Epilepsy: An Interim Analysis of a Randomized, Double­Blinded Comparative Clinical Trial with                                              Lamotrigine. Epilepsia 1999; 40 Suppl.2: 282. 

Montouris G, Mirza WU, Biton V, Vuong A, Barrett P, Hammer A. Effects of Lamictal and Depakot Monotherapy on Body                                 Weight in Patients with Epilepsy: Interim Analysis of a Randomized, Double-Blind Clinical Trial.                                             Neurology 1999; 52(6) Suppl.2: A523-A524. 

Abou-Khalil BW, Vazquez BR, Beydoun A, Elger CE, Biton V, Krauss GL, Smith TM, Greiner MJ, Knapp LE, Garofalo EA.                                      Pregabalin In-Patient Monotherapy Trial: A Double-Blind, Low-Dose Active-Controlled, Multicenter                                        Study in Patients with Refractory Partial Epilepsy. Neurology 1999; 52(6) Suppl.2: A390. 

Biton V, Vasquez B, Sachdeo R, Lenz G, Deaton R, Sommerville K. Adjunctive Tiagabine Compared with Phenytoin and                                     Carbamazepine in the Multicenter, Double-Blind Trial of Complex Partial Seizures. Epilepsia 1998; 39                                   Suppl.6: 125.

Vazquez B, Abou-Khalil B, Biton V, Smith T, Greiner M, Knapp L, Garofalo E. Pregabalin Monotherapy in Hospitalized                                         Patients: A Study Design for Early Demonstration of Anticonvulsant Efficacy. Epilepsia 1998; 39                                           Suppl.6: 67. 

Biton V, Chadwick D, Montouris GD, Shu-Chen W. Topiramate as Long-Term Therapy in Patients with Generalized Tonic-                                   Clonic Seizures without Focal Onset. Neurology 1998; 50(4) Suppl-4: A311-A312. 

Brodie MJ, Biton V, Montouris GD, Shu-Chen W. Topiramate Therapy in Patients with Generalized Tonic-Clonic Seizures                                   without Focal Onset: Long-Term Outcome. Epilepsia 1998; 39 Suppl.2: 2. 

Biton V, Montouris GD, Riviello JD, Reife R, & YTC Study Group. Efficacy And Safety Of Topiramate In Generalized Tonic-                                 Clonic Seizures Of Nonfocal Origin. Epilepsia 1997; 38 Suppl.8: 206-207. 

Biton V, Montouris GD, Riviello JD, Reife R, & Topiramate YTC Study Group. Topiramate as Add­ On Therapy in                                                     Generalized Seizures of Nonfocal Origin. Ann Neural 1997; 42(3): 502-503. 

Sachdeo RC, Biton V, Abou-Khalil B. Seizure-Free Patients in Topiramate Clinical Trials. Epi/epsia 1997; 38 Suppl.7: 13. 

Boop FA, Biton V, Souheaver GT, Yasargil MG. Post-operative Verbal memory Performance in Patients Following                                                Dominant Temporal Lobectomy versus Selective Amygdalohippocampectomy. Epilepsia 1997; 38                                        Suppl.3: 246. 

Montouris GD, Biton V, & YTC Study Team. Long-term Topiramate Therapy in Generalized Seizures of Non-focal Origin.                                     Epilepsia 1997; 38 Suppl.3: 82. 

Biton V, Montouris GD, & YTC Study Team. Topiramate Double-Blind Trial in Patients with Generalised Tonic-Clonic                                              Seizures Non-focal Origin. Epi/epsia 1997; 38 Suppl.3: 59. 

Biton V. Preliminary Open-Label Experience with Topiramate in Primary Generalized Seizures. Epilepsia 1997; 38                                                Suppl.1: 542-544. 

Biton V, Soellner S, Mercante D, Phillips H, Alto G, Sommerville K. Monotherapy with Tiagabine in an Open-Label Study                                         of Partial Seizures. Epilepsia 1996; 37 Suppl.4: 40. 

Biton V, Alto G, Pixton G, Sommerville K. Tiagabine Monotherapy in Adults and Children in a Long­-Term Study. Epilepsia                                     1996; 37 Suppl.5: 167. 

Biton V, Reife R, Kamin M, Bobrosky K. Topiramate as Add-on Therapy for Patients with Primary Generalized Epilepsy.                                          Neurology 1996; 46: A176. 

Schachter 5, Biton V, Soellner S, Edwards K, Cybulski K, Shu V, Hightower B, Sommerville K. Safety and Efficacy of                                                Tiagabine HCI Monotherapy in the Treatment of Partial Seizures: High Dose versus Low Dose.                                              Epilepsia 1995; Vol. 361 Suppl.3: 5148. 

Sachdeo RC, Biton V, Boellner SW, Schachter SC, Alto G, Kaply C, Philips HB, Kardatzke D, Pixton G, Sommerville KW.                                             Long Term Safety of Tiagabine HCI. Epilepsia 1995; Vol. 36, Suppl.4: 55. 

Schachter S, Biton V, Bergen D, Ahmann P, Rask CA, Smith S, Deaton R, Patterson R. Long-Term Safety of Tiagabine HCI.                                        Epilepsia 1993; 34, Suppl.6: 67. 

Biton V, Boop R. Ethotoin -A Last Resort Anti-Epileptic Drug. Epilepsia 1991; 32, Suppl.3: 61. 

Biton V, Fiol M, Gates J. Do lctal Events Originate from Areas of lnter-lctal Activity? A Chronically Implanted Subdural                                             Electrode Study. Epilepsia 1989 Oct; (30 )5: 694. 

Fiol M, Gates J, Biton V, Maxwell R. The Value of Subdural Electrode Array in the Surgical Treatment of Patients with                                               Widespread Temporal Lobe lnterictal Activity or Solitary Mid posterior Temporal MRI Lesions.                                               Epilepsia 1989; (30)5: 694. 

Biton V, Fiol M, Gates J, Maxwell R. Inhibitory Sensory Locus Defined by Direct Cortical Stimulation. J Clin Neurophysiol                                         1988; (5)4: 338-339. 

Biton V, Abramsky O. Newer Study Fails to Support Environmental Factors in Etiology of Multiple Sclerosis. Neurology                                             1986; 36: 184. 

Melamed E, Biton V, Zelig 0. Less Recognized Side Effects of Chronic Dopatherapy that may be caused by Faculty                                                    Absorption of L-Dopa: studies in Parkinsonian Fluctuators. Neurology 1985; 232 Suppl: 192. 

Melamed E, Biton V. Delayed Onset of Responses to Individual Doses of L-Dopa in Parkinsonian Fluctuators: An                                                        Additional Side Effect of Long Term L-Dopa Therapy. Neurology 1984; 34 Suppl.2: 270.

Clinical Drug Study Experience

Abbott Laboratories. Protocol Mo1-274. Principal Investigator. 
A Comparison of the Bioavai/ability of a Depakote ER Formulation Relative to the Depakote DR Tablet Formulation in Adult Patients with Epilepsy on the Depakote DR Tab/et Formulation and an Enzyme-Inducing Antiepileptic Drug. 

Abbott Laboratories. Protocol Mo1-313. Principal Investigator. 
An Evaluation of the Pharmacol Profile and Safety of Depakote Extended-Release Tablets in Pediatric Patients. 

Abbott Laboratories. Protocol Mo3-654. Principal Investigator. 
A 24-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Finding, Safety, Tolerability, and Efficacy Study of the Human Anti-lL-12 Antibody ABT-874 in Subjects with Multiple Sclerosis with a 24-Week Double-Blind, Active Extension Phase. 

Abbott Laboratories. Protocol M91-604. Principal Investigator. 
An Open-Label Extension Study of Tiagabine HCI in the Treatment of Patients with Partial Seizures.

Abbott Laboratories. Protocol M92-813. Principal Investigator. 
An Open-Label Study of the Safety of Long Term Tiagabine HCI Administration in Patients with Epilepsy. 

Abbott Laboratories. Protocol M92-825. Principal Investigator. 
Safety and Efficacy of Tiagabine HCI as Adjunctive Treatment. 

Abbott Laboratories. Protocol M96-421. Principal Investigator. 
Safety and Efficacy of Tiagabine HCI in the Treatment of Pediatric Patients with Partial Seizures. 

Abbott Laboratories. Protocol M97-655. Principal Investigator. 
Safety and Efficacy of Gabitri/ (Tiagabine HCI) as Adjunctive Treatment to Non-Hepatic Enzyme­ Inducing Antiepileptic Drugs. 

Abbott Laboratories. Protocol M99-114. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Comparison of the Safety and Efficacy of ABT-594 to Placebo in Subjects with Painful Diabetic Polyneuropathy. 

Accera, Inc. Protocol AC-12-010. Victor Biton, Principal Investigator. 
A 26-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Effects of Daily Administration of AC-1204 in Participants with Mild to Moderate Alzheimer’s Disease (AD) with an Optional 26-Week Open-Label Extension. 

Acorda Therapeutics, Inc. Protocol DZNS-EP-1019. Principal Investigator. 
An Open-Label, Randomized, Crossover Pharmacokinetic Study to Determine Relative Bioavailability, Safety and Tolerability of Single Doses of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®) in Patients with Refractory Epilepsy. 

Acorda Therapeutics, Inc. Protocol DZNS-EP-1025. Principal Investigator. 
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray in Adolescents and Adults with Cluster Seizures. 

Allergan. Protocol AGN 203818-004. Principal Investigator. 
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose, Parallel Design, Dose Ranging Study of the Safety and Efficacy of AGN 203818 in Patients with Painful Diabetic Peripheral Neuropathy. 

Astellas Pharma, Inc. Protocol 03-0-189. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Study to Evaluate the Safety and Efficacy of FK962 in Subjects with Mild-to-Moderate Alzheimer’s Disease. 

Astra Merck, Inc. Protocol 134. Principal Investigator. 
A Comparator Dose Controlled, Ascending Multiple Dose Safety and Tolerability Study of Remacemide Hydrochloride as an Adjunctive Therapy on Refractory Patients with Epilepsy. 

Astra Merck, Inc. Protocol 201. Principal Investigator. 
An Interaction Study Between H199/18 and Phenytoin in Epileptic Patients. 

Civitas Therapeutics, Inc. Protocol CVT-301-003. Principal Investigator. 
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients with Motor Response Fluctuations (OFF Phenomena). 

Cyberonics. Protocol E-20. Principal Investigator. 
A Randomized, Parallel-Group Comparison of Treatment with Pharmacotherapy or Adjunctive Vagus Nerve Stimulation Therapy for Pharmacoresistant Partial Seizures: A Large Simple Effectiveness Trial. 

Daichii Sankyo. Protocol DS5565-A-U201. Principal Investigator. 
A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy. 

Dainippon Sumitomo Pharma Co., Ltd. Protocol AC-3933-271. Principal Investigator. 
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Assessing the Efficacy and Safety of AC-3933 Tablets Twice Daily in Adults with Mild-to­ Moderate Alzheimer’s Disease. 

Depomed, Inc. Protocol 81-0046. Principal Investigator. 
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients with Painful Diabetic Peripheral Neuropathy. 

Depomed, Inc. Protocol 81-0068. Principal Investigator. 
A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa/Levodopa Tab/et in Patients with Advanced Parkinson’s Disease with Motor Fluctuations. 

Eisai Medical Research, Inc. Protocol E2007-Aoo1-206. Principal Investigator. 
A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 Given as Adjunctive Therapy in patients with Refractory Partial Seizures. 

Eisai Medical Research, Inc. Protocol E2007-Aoo1-207. Principal Investigator. 
A 4-Year Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 as an Adjunctive Therapy in Patients With Refractory Partial Seizures (revised per Amendment 02, 03, and 05). 

Eisai Medical Research, Inc. Protocol E2007-Aoo1-214. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Explore the Safety and Tolerability of Doses of E2007 Up to a Maximum of 6mg in Patients with Parkinson’s Disease Who Experience End-of-Dose “Wearing-Off” Motor Fluctuations. 

Eisai Medical Research, Inc. Protocol E2007-Aoo1-220. Principal Investigator. 
A Mutt/center, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 in Patients with Parkinson’s Disease Who Experience End-of-Dose ‘Wearing­Off’ Motor Fluctuations. 

Eisai Medical Research, Inc. Protocol E2007-Aoo1-302. Principal Investigator. 
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson’s Disease Patients with Motor Fluctuations. 

Eisai Medical Research, Inc. Protocol E2007-Gooo-303. Principal Investigator. 
A Multi-Centre, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson’s Disease Patients with Motor Fluctuations. 

Eisai Medical Research, Inc. Protocol E2007-Gooo-304. Principal Investigator. 
A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects with Refractory Partial Seizures. 

Eisai Medical Research, Inc. Protocol E2007-Gooo-307. Principal Investigator. 
A 14-Month Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects with Refractory Partial Seizures. 

Eisai Medical Research, Inc. Protocol E2007-Gooo-332. Principal Investigator. 
A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel-group Study with an Open­ label Extension Phase to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic-Clonic Seizures. 

Eisai Medical Research, Inc. Protocol E2080-Aoo1-301. Principal Investigator. 
A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients with Refractory Partial Seizures. 

Eisai Medical Research, Inc. Protocol E2080-Aoo1-302. Principal Investigator. 
An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients with Refractory Partial Seizures. 

Elan Pharmaceuticals, Inc. Protocol ELN115727-301. Principal Investigator. 
A Phase Ill, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Trial of Bapineuzumab (AAB 001, ELN115727) in Patients with Mild-to-Moderate Alzheimer’s Disease Who Are Apolipoprotein E £4 Non-Carriers. 

Elan Pharmaceuticals, Inc. Protocol ELN115727-302. Principal Investigator. 
A Phase Ill, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Trial of Bapineuzumab (AAB 001, ELN115727) in Patients with Mild-to-Moderate Alzheimer’s Disease Who Are Apolipoprotein E £4 Carriers. 

Elan Pharmaceuticals, Inc. Protocol ELN115727-351. Principal Investigator. 
A Phase 3 Extension, Multicenter, Double-Blind, Long Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects with Alzheimer’s Disease who Participated in Study £LN115727-301 or in Study ELN115727-302. 

Elan Pharmaceuticals, Inc. Protocol ZNS-501. Principal Investigator. 
A Multicenter, Open-Label, Assessment of the Safety of Zonegran ‘” as Adjunctive Therapy in Patients with Primary Generalized Epilepsy. 

Eunoe, Inc. Protocol 2000-01. Principal Investigator. 
A Prospective, Randomized Start, Multi-Center, Double-Blinded, Concurrently Placebo-Controlled Study to Evaluate the Effect of Flow-Regulated Ventriculoperitoneal Shunting on Progression of Alzheimer’s Disease: an Investigation of the Safety and Effectiveness of the COGNIShunt™ CNS Fluid Shunt System. 

Eunoe, Inc. Protocol 2000-01 E. Principal Investigator. 
Long-term Follow-on Safety Evaluation of the Cognishunt® CNS Fluid Shunt System Implanted under Pivotal Study 2000-01 in Subjects with Alzheimer’s Disease. 

Forest Laboratories, Inc. Protocol MEM-MD-06. Principal Investigator. 
An Evaluation of the Safety and Efficacy of Memantine in the Treatment of Chronic Pain in Patients with Painful Diabetic Neuropathy. 

Forest Research Institute. Protocol RG8-M D-02. Principal Investigator. 
A Randomized, Double-Blind, Placebo and Active Controlled Study of the Safety and Efficacy of RGH-896 in Patients with Diabetic Peripheral Neuropathic Pain. 

FORUM Pharmaceuticals. Protocol EVP-6124-025. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week, Phase 3 Study of Two Doses of EVP-6124 or Placebo in Subjects with Mild to Moderate Alzheimer’s Disease Currently or Previously Receiving an Acetylcho/inesterase Inhibitor Medication. 

FORUM Pharmaceuticals. Protocol EVP-6124-026. Principal Investigator. 
A 26-Week Extension Study of the Safety and Clinical Effects of EVP-6124 in Subjects with Alzheimer’s Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication. 

Fujisawa. Protocol 03-0-189. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects with Mild to Moderate Alzheimer’s Disease. 

Genentech, Inc. Protocol Ko622g. Principal Investigator. 
A Phase II, Mu/ticenter, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Recombinant Human Nerve Growth Factor in Patients with Diabetic Peripheral Polyneuropathy. 

Genentech, Inc. Protocol Ko717g. Principal Investigator. 
An Open-Label Extension Study of the Long Term Safety of Recombinant Human Nerve Growth Factor in the treatment of Subjects with Diabetic Neuropathy. 

 Genentech, Inc. Protocol Ko718g. Principal Investigator. 
A Phase Ill, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Recombinant Human Nerve Growth Factor in Subjects with Diabetic Neuropathy. 

Genentech, Inc. Protocol Ko807g. Principal Investigator. 
A Phase Ill, Open-Label Extension Study of the Long-Term Safety of Recombinant Human Nerve Growth Factor (rhNGF) in Treatment of Subjects with Diabetic Neuropathy. 

Genzyme. Protocol CAMMS223. Principal Investigator. 
A Phase 11, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose CAMPATH (MABCAMPATH) and High-Dose Rebif in Patients with Early, Active Relapsing-Remitting Multiple Sclerosis. 

GlaxoSmithKline. Protocol 164. Principal Investigator. 
An Open-Label, Randomized, Two-Part Study to Investigate the Relative Bioavailability of Ropinirole CR and IR Formulations and the Effect of Food on the Pharmacol

GlaxoSmithKline. Protocol AVA102670. Principal Investigator. 
A 54-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and Overall Clinical Response in APO£ 04- Stratified Subjects with Mild-to-Moderate Alzheimer’s Disease (REFLECT-3). 

GlaxoSmithKline. Protocol AVA102675. Principal Investigator. 
A 52-Week Open-Label Extension Study of the Long-Term Safety and Efficacy of Rosiglitazone Extended-Release (RSG XR) as Adjunctive Therapy to Acety/cholinesterase Inhibitors in Subjects with Mild-to-Moderate Alzheimer’s Disease (REFLECT-4). 

GlaxoSmithKline. Protocol LAM 100034. Principal Investigator. 
A Multi-Center, Double-Blind, Randomized, Parallel-Group Evaluation of Lamictal Extended­ Release Adjunctive Therapy in Patients with Partial Seizures. 

GlaxsoSmithKline. Protocol PXN110448. Principal Investigator. 
A Dose Response Study of XP13512, Compared with Concurrent Placebo Control and Pregabalin (Lyrica), in Subjects with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy. 

GlaxoSmithKline. Protocol LAM 100036. Principal Investigator. 
A Multi-Center, Double-Blind, Randomized, Parallel-Group Evaluation of Lamictal Extended­ Release Adjunctive Therapy in Patients with Primary Generalized Tonic-Clonic Seizures. 

GlaxoSmithKline. Protocol LAM40013. Principal Investigator. 
A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients with Epilepsy. 

GlaxoWellcome. Protocol LAM40097. Principal Investigator. 
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures. 

GlaxoSmithKline. Protocol LAM40112. Principal Investigator. 
A Double-Blind, Randomized Trial of Cognitive Effects of Lamictal (Lamotrigine) Versus Topiramate in Epilepsy.

GlaxoSmithKline. Protocol NPP30004. Principal Investigator. 
A Multicenter, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of Lamotrigine 2oomg/day, 3oomg/day and 4oomg/day Compared with Placebo in Subjects with Painful Diabetic Neuropathy. 

GlaxoSmithKline. Protocol NPP30006. Principal Investigator. 
An Open-Label Extension Study to Evaluate the Safety of Lamotrigine in Subjects with Painful Diabetic Neuropathy. 

GlaxoSmithKline. Protocol NPP30010. Principal Investigator. 
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Lamotrigine in Subjects with Neuropathic Pain and Inadequate Pain Relief with Gabapentin, Tricyclic Antidepressants or Non-Narcotic Analgesics. 

GlaxoWellcome. Protocol SCAA2001. Principal Investigator. 
A Pilot Open-Label Evaluation of the Safety, Tolerability, and Efficacy of Add-On 534U87 Treatment of Partial Seizures. 

GlaxoWellcome. Protocol SCAA4001. Principal Investigator. 
A Double-Blind, Double-Dummy, Parallel-Group Comparison of Lamotrigine and Divalproex Sodium Monotherapy in Patients with Generalized Seizures. 

Hoechst Marion Roussel, Inc. Protocol 071754PRO223 Principal Investigator. 
A Dose Response Study of Efficacy and Safety of Vigabatrin 1, 3, 4, and 6 gm/day as Monotherapy in Patients with Complex Partial Seizures. 

Hoechst Marion Roussel, Inc. Protocol 071754PRO242. Principal Investigator. 
An Open-Label, Follow-Up, Long-Term Maintenance Study of Vigabatrin as Monotherapy in Patients with Complex Partial Seizures. 

Hoechst Marion Roussel, Inc. Protocol VGPR0098/VGST1245. Principal Investigator. 
Clinical Experience and Use of Sabril in Patients with Partial Seizures.

lcagen. Protocol lCA-105665-02. Principal Investigator. 
A Phase 1, Mu/ti-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Oral Doses of ICA-105665 in Healthy Subjects and in Patients with Epilepsy. 

lcagen. Protocol lCA-105665-04. Principal Investigator. 
A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of /CA-105665 in Epilepsy Patients with a Photo-Induced Paroxysmal EEG Response. 

lkano. Protocol MZ0917. Principal Investigator. 
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Cross-Over Study of the Safety and Efficacy of Intranasal Midazolam in the Outpatient Treatment of Subjects with Seizure Clusters. 

ILEX Pharmaceuticals. Protocol CAMMS223-A1. Principal Investigator. 
A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose CAMPA TH® (MABCAMPATH®) and High-Dose Rebif® in Patients with Early, Active Relapsing-Remitting Multiple Sclerosis. 

Impax. Protocol lPX066-B09-02. Principal Investigator. 
A Study to Evaluate the Safety and Efficacy of IPXo66 in Advanced Parkinson’s Disease.

lmpax. Protocol lPX066-B09-03. Principal Investigator. 
An Open-Label Extension Study of the Safety and Clinical Utility of IPXo66 in Subjects with Parkinson’s Disease. 

lmpax. Protocol lPX203-B14-02. Principal Investigator. 
A Study to Assess The Pharmacokinetics and Pharmacodynamics of Single Dose of IPX203 In Patients With Advanced Parkinson’s Disease. 

lmpax. Protocol I PX203-B16-01. Principal Investigator. 
A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of /PX203 in Subjects with Advanced Parkinson’s Disease. 

lnsmed Inc. Protocol lNS1-DM-28. Principal Investigator. 
A Randomized, Multicenter, Double-Blind, Parallel-Group Clinical Study to Compare the Effects of JNS-1 (D-Chiro-lnositol) versus Placebo as Oral Therapy in Subjects with Type 2 Diabetes Mellitus Who Fail to Achieve Adequate Glycemic Control with Diet and Exercise. 

Intranasal Therapeutics, Inc. Protocol MZ0815. Principal Investigator. 
A Randomized Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Ascending Single Doses and Two Doses of Intranasal Midazolam in Subjects with Epilepsy. 

Ivax Laboratories. Protocol IXL-201-14-189. Principal Investigator. 
Efficacy and Safety of T alampanel as Adjunctive Therapy in Patients with Partial Seizures: a Phase II Clinical Trial. 

Ivax Laboratories. Protocol IXL – 201 F-14 -189. Principal Investigator. 
Talampanel Open-Label Adjunctive Therapy: A Follow-On Study to Determine Long-Term Safety and Efficacy in Patients with Partial Seizures. 

Jazz Pharmaceuticals, Inc. Protocol 06-001. Principal Investigator. 
A Non-Randomized, Within Subject, Placebo-Controlled Exploratory Study of the Effects of JZP-4 on the Photic-lnduced Paroxysmal EEG Response in Patients with Photosensitive Epilepsy. 

Jazz Pharmaceuticals, Inc. Protocol 07-001. Principal Investigator. 
A Phase 2a, Open-Label, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects with Epileptic Seizures. 

Johnson & Johnson Pharmaceutical Research & Development. 
Protocol 333369-EPY-2001; 333369-EPY-2002. Principal Investigator. 
A Double Blind, Placebo-Controlled, Dose-Titration Study to Determine Safety, Tolerability and Preliminary Efficacy of RWJ-333369 as Adjunctive Therapy in Subjects with Treatment­Resistant Partial Seizures (with or without Secondary Generalization) or Primarily Generalized Tonic-Clonic Seizures. 

Johnson & Johnson Pharmaceutical Research & Development. 
Protocol 333369-EPY-2003; 333369-EPY-2006. Principal Investigator. 
A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Refractory Partial Seizures. 

Johnson & Johnson Pharmaceutical Research & Development. 
Protocol 333369-EPY-3001; 3333609-EPY-3004. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Subjects with Partial­Onset Seizures Followed by an Open-Label Extension Study. 

King Pharmaceuticals/Pfizer. Protocol K826-05-3001. Principal Investigator. 
A Phase Ill, Randomized, Double-Blind, Parallel, Placebo-Controlled, Multi-Center Study, with Optional Open-Label Continuation, of the Efficacy and Safety of Vanquix™ Auto-Injector (Diazepam Injection) for the Management of Selected, Refractory, Patients with Epilepsy Who Require Intermittent Medical Intervention to Control Episodes of Acute Repetitive Seizures. 

Lorex Pharmaceuticals. Protocol LESO1. Principal Investigator. 
An Evaluation of the Efficacy and Safety of Eli prod ii in Patients with Acute lschemic Stroke. 

Lundbeck. Protocol 13181A. Principal Investigator. 
An Open-Label Study to Assess the Safety and Tolerability of Intravenous Carbamazepine as Short­ Term Replacement of Oral Carbamazepine in Adult Patients with Epilepsy. 

Lundbeck. Protocol 14861A. Principal Investigator. 
Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study of Lu AE58054 in Patients with Mild-Moderate Alzheimer’s Disease Treated with Donepezil. 

Lundbeck. Protocol 14861B. Principal Investigator. 
An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lu AE58054 as Adjunctive Treatment to Donepezil in Patients with Mild-Moderate Alzheimer’s Disease. 

Marinus Pharmaceuticals, Inc. Protocol 1042-0600. Principal Investigator. 
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxo/one as Add-on Therapy in Adult Subjects with Epilepsy Consisting of Uncontrolled Partial-Onset Seizures. 

Marinus Pharmaceuticals, Inc. Protocol 1042-0601. Principal Investigator. 
An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxalone as Add-On Therapy in Adult Patients with Epilepsy Consisting of Uncontrolled Partial-Onset Seizures. 

Marinus Pharmaceuticals, Inc. Protocol 1042-0603. Principal Investigator. 
A Multicenter, Double Blind, Randomized, Placebo-Controlled Trial to Determine the Efficacy and Safety of Ganaxolone as Adjunctive Therapy for Adults with Drug-Resistant Partial-Onset Seizures Followed by Long-term Open-Label Treatment. 

Medivation. Protocol DIM 18. Principal Investigator. 
A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients with Mild-to-Moderate Alzheimer’s Disease on Donepezil. 

Medivation. Protocol DIM 18 EXT. Principal Investigator. 
An Open-Label Extension of the CONCERT Protocol (D/M18) Evaluating Dimebon (Latrepirdine) in Patients with Alzheimer’s Disease. 

Merck. Protocol 021-00. Principal Investigator. 
A Phase Ila, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 in Patients with Painful Diabetic Neuropathy. 

Merck. Protocol MK-7622-012. Principal Investigator. 
A Seamless Phase Ila/lib, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of MK-7622 as an Adjunctive Therapy to Donepezil for Symptomatic Treatment in Subjects with Alzheimer’s Disease. 

Myriad Pharmaceuticals, Inc. Protocol MPC-7869-04-005. Principal Investigator. 
A Phase Ill, Randomized, Double-Blind, Placebo-Controlled, Study of the Effect of Daily Treatment with MPC-7869 on Measures of Cognitive and Global Function in Subjects with Mild-to­Moderate Dementia of the Alzheimer’s Type. 

Nestle Health Science-Pamlab, Inc. Protocol M-003. Principal Investigator. 
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to assess the safety and nutritional benefits of Metanx® in Subjects with Diabetic Peripheral Neuropathy (MEDIAN Study). 

Neurelis. Protocol DIAZ.001.05. Principal Investigator. 
A 12-Month, Open-Label, Repeat-Dose Safety Study of NRL-1 in Epilepsy Subjects. 

Novartis Pharmaceuticals. Protocol CRUF3310038. Principal Investigator. 
A Multicenter, Double-Blind, Randomized, Placebo-Control, Parallel-Group, Monotherapy Study of Rufinamide in Patients with Refractory Partial Seizures Who Have Completed an Evaluation for Epilepsy Surgery. 

Novartis Pharmaceuticals. Protocol CRUF3310039. Principal Investigator. 
Multicenter, Double-Blind, Randomized, Placebo-Control, Parallel-Group Monotherapy Study of Rufinamide in Patients with Recent-Onset Partial Seizures. 

Novartis Pharmaceuticals. Protocol 3310101016. Principal Investigator. 
Safety and Efficacy of High-Versus Low-Dose Rufinamide Monotherapy in Patients with Inadequately Controlled Partial Seizures. 

Novartis Pharmaceuticals. Protocol 3310101018. Principal Investigator. 
A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Trial of Rufinamide as Adjunctive Therapy in Patients with Inadequately Controlled Primary Generalized Tonic-Clonic Seizures. 

NPS Pharmaceuticals, Inc. Protocol CL1776-014. Principal Investigator. 
A Proof of Concept Phase II Study of the Efficacy and Safety of Various Plasma Levels of lsovaleramide in the Photic Model in Subjects with Photosensitive Epilepsy. 

Ortho-McNeil Pharmaceutical. Protocol CAPSS-027. Principal Investigator. 
A Double-Blind, Placebo Controlled, Parallel Study to Evaluate the Efficacy of Topamax@ (Topiramate) Compared to Valproate as Add-On Therapy to Carbamazepine with Special Emphasis on Cognitive Function in Subjects with Partial-Onset Seizures. 

Ortho-McNeil Pharmaceutical. Protocol CAPSS-272. Principal Investigator. 
A Double-Blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate Versus Phenytoin in Subjects with Seizures Indicative of New-Onset Epilepsy. 

Ortho-McNeil Pharmaceutical. Protocol TPS-TR/TPS-TR ext. Principal Investigator. 
A Randomized, Double-Blind, Parallel-Design, Multicenter Trial to Evaluate Two Titration Rates of Oral Topamax (Topiramate) in Subjects with Epilepsy. 

Ovation Pharmaceuticals. Protocol OV-1015. Principal Investigator. 
A Sequential, Open-Label Study of the Pharmacokinetics and Safety of Intravenous Carbamazepine Relative to Oral Carbamazepine in Adult Patients with Epilepsy. 

Parke-Davis Pharmaceutical Research. Protocol 1008-007. Principal Investigator. 
A Pregabalin In-Patient Monotherapy Trial: a Double-Blind, Positive-Controlled, Multicenter Study in Patients with Refractory Partial Epilepsy. 

Parke-Davis Pharmaceutical Research. Protocol 1008-008. Principal Investigator. 
A Pregabalin Open-Label, Follow-On Safety Trial in Patients with Refractory Partial Epilepsy. 

Parke-Davis Pharmaceutical Research. Protocol 1008-009. Principal Investigator. 
A Pregabalin Add-On Trial: a Double-Blind, Placebo-Controlled, Multicenter Study in Patients with Partial Seizures. 

Parke-Davis Pharmaceutical Research. Protocol 1008-010. Principal Investigator. 
A Pregabalin Open-Label Add-On Trial: an Open-Label, Multicenter Follow-On Study to Determine 
Long-Term Safety and Efficacy in Patients with Partial Seizures. 

Parke-Davis Pharmaceutical Research. Protocol 1008-029. Principal Investigator. 
A 5-Week, Double-Blind, Placebo-Controlled Trial of 3 Dosages of Pregabalin (75, 300, 6oomg/day) for Treatment of Painful Diabetic Peripheral Neuropathy. 

Parke-Davis Pharmaceutical Research. Protocol 1008-033. Principal Investigator. 
A Pregabalin Open-Label, Extension Safety Trial in Patients with Chronic Pain. 

Pfizer. Protocol Aoo81096. Principal Investigator. 
Prospective Randomized 12-Week Controlled Study of Visual Field Change in Subjects with Partial Seizures Receiving Pregabalin or Placebo.

Pfizer. Protocol Aoo81194. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Mu/ti-Center Trial of Pregabalin Controlled Release Formulation as Adjunctive Therapy in Adult Patients with Partial Onset Seizures. 

Pfizer. Protocol A4091031. Principal Investigator. 
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Proof-of­-Concept Study of the Analgesic Effects of Tanezumab in Adult Patients with Diabetic Peripheral Neuropathy. 

Pfizer. Protocol B1451027. Principal Investigator. 
A Phase 31 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Dimebon (PF-01913539) for up to 26 Weeks In Patients with Mild-to­Moderate Alzheimer’s Disease. 

Pfizer. Protocol B1451029. Principal Investigator. 
An Open-Label Extension to the 81451027 Protocol to Evaluate the Long-Term Safety and Tolerability of Dimebon (PF-01913539) In Patients with Alzheimer’s Disease. 

Pfizer. Protocol M/2760/001. Principal Investigator. 
Sumanirole: Open-Label, Long Term, Flexible Dose Study of Safety, Tolerability and Therapeutic Response in Patients with Parkinson’s Disease. 

Pharmacia & Upjohn. Protocol 666E-CNS-0075-021. Principal Investigator. 
A Phase Ill, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients with Early Parkinson’s Disease. 

Pharmacia & Upjohn. Protocol M/2760/0009. Principal Investigator. 
A Double-Blind, Placebo-Controlled, Dose Response Study of Tolerability, Safety, and Efficacy in Patients with Early Parkinson’s Disease. 

Pharmacia & Upjohn. Protocol M/2760/0011. Principal Investigator. 
An Open-Label, Long Term, Flexible Dose Study of Safety, Tolerability, and Therapeutic Response in Patients with Parkinson’s Disease. 

R.W. Johnson Pharm. Research Inst. Protocol TOPMAT-EPMN-104. Principal Investigator. 
A Topiramate Monotherapy Clinical Trial in Subjects with Recently Diagnosed Partial-Onset Seizures. 

R.W. Johnson Pharm. Research Inst. Protocol TOPMAT-EPMN-105. Principal Investigator. 
A Topamax® Topiramate Monotherapy Comparison Trial to Standard Monotherapy in the Treatment of Newly Diagnosed Epilepsy. 
 
R.W. Johnson Pharm. Research Inst. Protocol TRAMAP-ANAG-006. Principal Investigator. 
An Evaluation of the Relative Potency and Safety of Tramadol with Acetaminophen Compared to Acetaminophen with Codeine in Chronic Pain of Benign Origin. 
 
R.W. Johnson Pharm. Research Inst. Protocol TRAMAP-ANAG-008. Principal Investigator.
Tramadol with Acetaminophen in the Pain of Osteoarthritis of the Hip and Knee. 
 
R.W. Johnson Pharm. Research Inst. Protocol TRAMAP-ANAG-009. Principal Investigator.
Tramadol with Acetaminophen in Low Back Pain of Non-Malignant Origin.
 
R.W. Johnson Pharm. Research Inst. Protocol YTC/YTC-E. Principal Investigator. 
A Topiramate Clinical Trial in Primary Generalized Tonic-Clonic Seizures. 
 
Saegis Pharmaceuticals. Protocol SGS742-CL02. Principal Investigator. 
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Efficacy and Safety of SGS742 in Subjects with Mild-to-Moderate Alzheimer’s Disease. 
 
Schering-Plough. Protocol Po4938. Principal Investigator. 
A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. 
 
Schering-Plough. Protocol Po6053. Principal Investigator. 
A Phase 31 40-Week, Active-Controlled, Double-Blind, Double Dummy Extension Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. 
 
Schwabe. Protocol LSG-1. Principal Investigator. 
A Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Losigamone in Patients with Inadequately Controlled Partial Seizures. 
 
Schwarz BioSciences. Protocol SP614. Principal Investigator. 
A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy. 
 
Schwarz Biosciences. Protocol SP615. Principal Investigator. 
An Open-Label Extension Trial to Determine Tolerability and Efficacy of Long-Term Oral SPM 927 as Adjunctive Therapy in Patients with Partial Seizures. 
 
Schwarz BioSciences. Protocol SP616. Principal Investigator. 
A Multicenter, Double-blind, Double-Dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects with Partial Seizures with or without Secondary Generalization. 
 
Schwarz Biosciences. Protocol SP665. Principal Investigator. 
An Open-Label Follow-On Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects with Diabetic Neuropathy. 
 
Schwarz Biosciences. Protocol SP667. Principal Investigator. 
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (20omg/day, 4oomg/day, 6oomg/day) as Adjunctive Therapy in Subjects with Partial Seizures with or without Secondary Generalization. 
 
Schwarz Biosciences. Protocol SP742. Principal Investigator. 
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of 200, 400, and 6oomg/day SPM 927 in Subjects with Painful Distal Diabetic Neuropathy. 
 
Schwarz Biosciences. Protocol SP745. Principal Investigator. 
A Multi-Center, Open-Label, Follow-On Trial to Assess the Long-Term Safety and Efficacy of SPM 927 with Painful Distal Diabetic Neuropathy. 
 
Schwarz BioSciences. Protocol SP754. Principal Investigator. 
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of SPM 927 ( 400 and 6oomg/day) as Adjunctive Therapy in Subjects with Partial Seizures with or without Secondary Generalization. 
 
Schwarz Biosciences. Protocol SP756. Principal Investigator. 
An Open-Label Extension Trial to Determine Safety and Efficacy of Long-Term Oral SPM 927 in Patients with Partial Seizures. 
 
Schwarz Biosciences. Protocol SP757. Principal Investigator. 
A Multi-Center, Open-Label Trial to Investigate the Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects with Partial Seizures with or without Secondary Generalization. 
 
Schwarz Biosciences. Protocol SP768. Principal Investigator. 
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600 mg/day) in Subjects with Painful Distal Diabetic Neuropathy. 
 
Schwarz Biosciences. Protocol SP780. Principal Investigator. 
A Multicenter, Open-Label Trial to Assess Subject Preference of PARCOPA, Carbidopa/ Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects with Stable Parkinson’s Disease. 
 
Schwarz Biosciences. Protocol SP902. Principal Investigator. 
A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/day Monotherapy in Subjects with Partial-Onset Seizures. 
 
Schwarz Biosciences. Protocol SP904. Principal Investigator. 
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-Onset Seizures. 
 
Schwarz Biosciences. Protocol SP961. Principal Investigator. 
An Open-Label Pilot Study to Assess the Safety of Oral Lacosamide as Adjunctive therapy for Uncontrolled Primary Generalized Tonic Clonic Seizures in Subjects with Idiopathic Generalized Epilepsy. 
 
Schwarz Biosciences. Protocol SP962. Principal Investigator. 
An Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated with Long­ Term Oral Lacosamide for Uncontrolled Primary Generalized Tonic Clonic Seizures in Subjects with Idiopathic Generalized Epilepsy. 
 
SK Life Science. Protocol SKL11197Coo6. Principal Investigator. 
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, 
Safety and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy. 
 
SK Life Science. Protocol YKP3089Co13. Principal Investigator. 
A Phase 2, Multicenter, Double-Blind, Randomized, Adjunctive Placebo-Controlled Trial to Evaluate the Efficacy and Safety of YKP3089 in Subjects with Treatment Resistant Partial Onset Seizures. 
 
SK Life Science. Protocol YKP3089Co17. Principal Investigator. 
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects with Partial Onset Seizures, with Optional Open-Label Extension. 
 
SK Life Science. Protocol YKP3089Co21. Principal Investigator. 
An Open-Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects with Partial Onset Seizures. 
 
SkyePharma. Protocol Skye-2003(/101468/166. Principal Investigator. 
A Phase II, Randomized, Double-Blind, Active-Controlled, Dose Escalation Study to Determine the Maximum Well-Tolerated Starting Dose of Ropinirole CR in Parkinson’s Disease Patients not Receiving Other Dopaminergic Therapies. 
 
SkyePharma. Protocol Skye-2004(/101468/167. Principal Investigator. 
A Phase II, Randomised, Double-Blind, Active-Controlled Study To Determine The Optimal Initial Titration Regimen Of Ropinirole CR Tablets In Parkinson’s Disease Patients Not Receiving Other Dopaminergic Therapies. 
 
SkyePharma. Protocol Skye-2005(/101468/196. Principal Investigator. 
A Long-Term, Open-Label Continuation Study of Once-Daily Administration of Ropinirole CR Tablets to Patients with Parkinson’s Disease Who Completed the Previous Ropinirole CR Studies 167 & 164. 
 
SmithKline Beecham Pharmaceuticals. Protocol SB204269/008. Principal Investigator. 
A Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SB 204269 as Add-On Therapy in Patients with Refractory Simple or Complex Partial Seizures (with or without Secondary Generalization). 
 
SmithKline Beecham Pharmaceuticals. Protocol SB204269/009. Principal Investigator. 
An Open-label Study to Evaluate the Long-Term Safety of SB 204269 as Add-On Therapy in Patients with Refractory Simple or Complex Partial Seizures (with or without Secondary Generalization). 
 
Sunovion. Protocol BIA 2093-304. Principal Investigator. 
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicentre Clinical Trial. 
 
Supernus. Protocol 538P108. Principal Investigator. 
A Conversion Study to Determine the Relative Bioavailability of TPM CR vs TPM IR in Subjects with Epilepsy.
 
UCB Biosciences, Inc. Protocol EP0012. Principal Investigator. 
An Open-Label, Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects with Idiopathic Generalized Epilepsy. 
 
UCB Biosciences, Inc. Protocol SP0982. Principal Investigator. 
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects with Idiopathic Generalized Epilepsy. 
 
UCB Pharma, Inc. Protocol No1172. Principal Investigator. 
A Multicenter, Open-label, Unilateral Interaction Study of UCB 34714 (400 mg daily) on Stable Phenytoin Monotherapy During a 45 Day b.i.d. Administration Period in 15 Adult Subjects Suffering from Epilepsy. 
 
UCB Pharma, Inc. Protocol No1191. Principal Investigator. 
An Open-Label, Exploratory, Multi-Center, Dose-Escalation Study Examining the Efficacy, Safety and Tolerability of UCB 44212 Used at Doses of 10mg, 20mg, 40mg, and 80mg b.i.d. (Total Daily Dose of 20 to 160mg) in Adult Subjects (18-65 Years) with Refractory Epilepsy Suffering from Partial-Onset Seizures (Whether or Not Secondarily Generalized) and Treated with 1, 2, or 3 Approved Antiepileptic Drugs. 
 
UCB Pharma, Inc. Protocol No1192. Principal Investigator. 
An Open-Label, Exploratory, Dose-Escalation, Multi-Center Study Examining the Safety, Tolerability and Efficacy of UCB 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80mg b.i.d. (Total Daily Doses of 20-16omg) Administration (Oral Capsules) in Adult Subjects (18-65 Years) with Refractory Epilepsy Suffering from Partial-Onset Seizures Who Are Currently Receiving 
Levetiracetam (LEV) But Still Experiencing Seizures. 
 
UCB Pharma, Inc. Protocol No1193. Principal Investigator. 
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 4 Parallel Groups, Dose-Ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and50 mg/day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 Weeks in Subjects from 16 to 65 Years with Refractory Epilepsy Suffering from Partial-Onset Seizures Whether or Not Secondarily Generalized. 
 
UCB Pharma, Inc. Protocol No1199. Principal Investigator. 
An Open-Label, Multicenter, Fol/ow-up Trial to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/day in Subjects Aged 16 Years or Older Suffering from Epilepsy. 
 
UCB Pharma, Inc. Protocol No1253. Principal Investigator. 
An International, Double-Blind, Parallel-Group, Placebo-Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (L16 to 70 Years Old) with Partial-Onset Seizures. 
 
UCB Pharma, Inc. Protocol No1258. Principal Investigator. 
A Multicenter, Open-Label, Four-Arm, Randomized Trial Evaluating the Safety and Tolerability of Brivaracetam Intravenous Infusion and Bulos, Administered in BID Regimen as an Adjunctive Antiepileptic Treatment in Subjects from 16 to 70 Years Suffering from Epilepsy. 
 
UCB Pharma, Inc. Protocol No1280. Principal Investigator. 
A Multi-Center, Double-Blind, Historical Control, Randomized Conversion to Monotherapy Study with Keppra XR for Treatment of Partial-Onset seizures. 
 
UCB Pharma, Inc. Protocol No1281. Principal Investigator. 
An Open-Label, Long-Term Follow-Up Study with Keppra XR for Treatment of Partial-Onset Seizures.
 
UCB Pharma, Inc. Protocol No1340. Principal Investigator. 
An Open-Label, Multicenter, Parallel-Group, Two-Arm Study Comparing the Pharmacokinetics of Keppra XR in Children (Aged 12-16 years old) with Epilepsy and in Adults (Aged 18-55 Years Old) with Epilepsy. 
 
UCB Pharma, Inc. Protocol No1358. Principal Investigator. 
A Randomized, Double-Blind, Placebo Controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (>=16 to 8o Years Old) with Partial Onset Seizures. 
 
UCB Pharma, Inc. Protocol No1372. Principal Investigator. 
An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older with Epilepsy. 
 
UCB Pharma, Inc. Protocol No1379. Principal Investigator. 
An Open-Label, Multicenter, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older with Partial Onset Seizures. 
 
UCB Pharma, Inc. Protocol No1395. Principal Investigator. 
An Open-Label, Multicenter, Single-Arm, Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects with Epilepsy Switching from Levetiracetam to Brivaracetam Due to Nonpsychotic Behavioral Side Effects. 
 
UCB Pharma, Inc. Protocol RPCE94A2201. Principal Investigator. 
A Long-Term, Open-Label, Multicenter Study of the Safety and Efficacy of UCB LO59 (Levetiracetam) 500mg Tablets at Individualized Oral Doses Ranging from 1000mg/day to 4000mg/day in the Treatment of Epilepsy. 
 
UCB Pharma, Inc. Protocol RPCE94J1403. Principal Investigator. 
A Multicenter Follow-Up Study of the Safety and Efficacy of Oral 500mg Tablets UCB LO59 in Patients with Partial Onset Epileptic Seizures: a 6-Week, Double-Blind Titration to 3ooomg/day, Followed by an Open Treatment Phase at Individualized Doses. 
 
UCB Pharma, Inc. Protocol RPCE98B2501. Principal Investigator. 
A Multicenter, Double-Blind, Randomized, Parallel Group Study Comparing the Safety and Efficacy of 3,000mg of Levetiracetam to 1,000mg of Valproate Used as Monotherapy in Epileptic Patients with Complex Partial Seizures. 
 
UCB Pharma Inc. Protocol RPCE99Ko602. Principal Investigator. 
A Multicenter, Open-Label, Long-Term Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (1-4g/Day) In Epilepsy Subjects With Partial Seizures. 
 
UCB Pharma, Inc. Protocol SP0993. Principal Investigator. 
A Multicenter, Double-Blind, Double-Dummy, Randomized, Positive-Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 6oomg/day) to Controlled Release Carbamazepine (400 to 1200mg/day), Used As Monotherapy In Subjects (>=16 years) Newly or Recently Diagnosed with Epilepsy and Experiencing Partial-Onset or Generalized Tonic­Clonic Seizures. 
 
UCB Pharma, Inc. Protocol SP0994. Principal Investigator. 
A Multicenter, Double-Blind, Double-Dummy, Follow-Up Study Evaluating the Long-Term Safety of Lacosamide (200 to 6oomg/day) in Comparison with Controlled-Release Carbamazepine (400 to 1200 mg/day), Used as Monotherapy in Subjects with Partial-Onset or Generalized Tonic-Clonic Seizures >=16 Years of Age Coming from the SP0993 Study. 
 
Upsher-Smith. Protocol P261-201. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intranasal Midazolam (USL261) in Adult Subjects with Epilepsy on Stable Ant/epileptic Drug Regimens. 
 
Upsher-Smith. Protocol P261-401. Principal Investigator. 
A Randomized, Double Blind, Placebo-Controlled Study of the Safety and Efficacy of Intranasal Midazolam in the Outpatient Treatment of Subjects with Seizure Clusters. 
 
Upsher-Smith. Protocol P261-402. Principal Investigator. 
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters. 
 
Valeant Research & Development. Protocol VRX-RET-E22-301. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Phase Ill Study to Determine the Efficacy and Safety of Retigabine (1200 mg/day) Used as Adjunctive Therapy in Refractory Epilepsy Patients with Partial-Onset Seizures. 
 
Valeant Research & Development. Protocol VRX-RET-E22-303. Principal Investigator. 
A Multi-Center, Open-Label, Long-Term, Safety, Tolerability and Efficacy Study of Retigabine in Adult 
Epilepsy Patients with Partial-Onset Seizures (Extension of Study VRX-RET-E22-301). 
 
Vernal is. Protocol V3381-2DPN P-02. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of the Safety, Tolerability and Efficacy of V3381 for Up to 13 Weeks in Patients with Diabetic Peripheral Neuropathic Pain (DPNP). 
 
Vertex. Protocol VX09-765-401. Principal Investigator. 
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of VX-765 in Subjects with Treatment­-Resistant Partial Epilepsy.
 
Vertex. Protocol VX11-765-402. Principal Investigator. 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of VX-765 in Subjects with Treatment-Resistant Partial Epilepsy with a 24-Week Open-Label Extension. 
 
ViroMed/VM BioPharma. Protocol VMDN-003. Principal Investigator. 
A Phase Ill, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 in Subjects with Painful Diabetic Peripheral Neuropathy. 
 
Wyeth-Ayerst Research. Protocol 3065A1-202. Principal Investigator. 
A Multicenter, Open-Label, Safety, Tolerability & Preliminary Efficacy Study of GKE-841 Administered as Add-On Therapy to Patients with Epilepsy Currently Receiving Monotherapy with an Established Anticonvulsive Agent. 
 
Wyeth-Ayerst Research. Protocol 3065A1-205. Principal Investigator. 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Dose-Ranging, Efficacy and Safety Study of Retigabine Administered as Add-On-Therapy in patients with Partial Epilepsy. 
 
Wyeth-Ayerst Research. Protocol 3065A1-208. Principal Investigator. 
A Multicenter, Open-Label, Long-Term, Safety, Tolerability, and Efficacy Study of GKE-841 in Adult Patients with Epilepsy. 
 
Wyeth-Ayerst Research. Protocol 3065A1-212. Principal Investigator. 
A Multicenter, Open-Label, Long-term, Safety, Tolerability and Efficacy Study of Retigabine (GKE-841) in Adult Patients with Partial Epilepsy. 
 
Wyeth-Ayerst Research. Protocol 3065A1-214. Principal Investigator. 
A Randomized, Double-blind, Parallel-group, Exploratory Safety and Tolerability Study of 3 Titration Rates of Retigabine Administered as Add-on therapy in Patients with Refractory Partial Epilepsy. 
 
Wyeth-Ayerst Research. Protocol 3065A1-216. Principal Investigator. 
A Multicenter, Open-Label, Long-Term Extension, Safety and Tolerability Study of Retigabine (GKE-841) in Adult Patients with Partial Epilepsy. 
 
Wyeth/Pfizer. Protocol 3133K1-3000. Principal Investigator. 
A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB 001, ELN115727) in Subjects with Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E4 Non-Carriers. 
 
Wyeth/Pfizer. Protocol 3133K1-3001. Principal Investigator. 
A Phase 31 Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB 001, ELN115727) in Subjects with Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E4 Carriers. 
 
Wyeth/Pfizer. Protocol 3133K1-3002. Principal Investigator. 
A Phase 3 Extension, Multicenter, Double-Blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-0011 ELN115727) in Subjects with Alzheimer Disease Who Are Apolipoprotein E E4 Noncarriers and Participated in Study 3133K1-3000-US. 
 
Wyeth/Pfizer. Protocol 3133K1-3003. Principal Investigator. 
A Phase 3, Multicenter, Parallel-Group, Long Term Safety and Tolerability Trial of Bapineuzumab (AAB 001, ELN115727) in Subjects with Alzheimer’s Disease who Participated in Study 3133K1-3001. 
 
XenoPort. Protocol XP-C-069. Principal Investigator. 
A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson’s Disease Subjects with Motor Fluctuations. 
 
XTL Development, Inc. Protocol XTL B07-001. Principal Investigator. 
A Double-Blind, Randomized, Placebo-Controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients with Chronic Neuropathic Pain Associated with Diabetic Peripheral Neuropathy. 
 
XTL Development, Inc. Protocol XTL B07-002. Principal Investigator. 
An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients with Chronic Neuropathic Pain Associated with Diabetic Peripheral Neuropathy.