Research in the Division of Epilepsy at The Ohio State University Medical Center
The Epilepsy Division of the Department of Neurology is currently engaged in XX clinical trials with XXX patients enrolled.
Current and historical clinical trials by faculty member:
Clinical Trials - Sheri Cotterman-Hart, M.D., Ph.D. - click here to expand or contract list -
| 9/2007 – ongoing | Biofeedback in Non-Epileptic Spells |
Clinical Trials - Lucretia Long, M.S., R.N., C.A.N.P. - click here to expand or contract list -
| 9/2002 - 12/2003 | Principal investigator: The Validity and Reliability of the Knowledge of Women’s Issues and Epilepsy (KOWIE) Questionnaires I and II. |
| 9/1999 – 12/2003 | Principal investigator: The Use of the Knowledge of Women’s Issues and Epilepsy (K.O.W.I.E) Questionnaire in Female Patients with Epilepsy. |
| 9/1997 – 12/1998 | Principal Investigator: Use of an Educational Assessment Questionnaire in Patients with Epilepsy. |
| 6/1996 - 1/1997 | Principal Investigator: The Incidence of Burns in Patients with Epilepsy. |
| 3/1997 - 9/2000 | Principal Investigator: The Effects of an Exercise Program on Outcomes in Patients with Epilepsy. |
| 3/1995 – 9/1999 | Co- Investigator: The Effect of Methylphenidate on Cognitive Function in Epilepsy Patients |
Clinical Trials - James McAuley, Ph.D. - click here to expand or contract list -
| Available upon request. | |
Clinical Trials - J. Layne Moore, M.D., M.P.H. - click here to expand or contract list -
| Co-investigator, Tiagabine HCL, Protocol M91-605, "Safety and Efficacy of BID and QID dosing with Tiagabine HCL versus Placebo as Adjunctive Treatment for Partial Seizures". | |
| Co-investigator, Tiagabine HCL, Protocol M91-604, "An Open-Label Extension Study of Tiagabine HCL in the Treatment of Patients with Partial Seizures". Mayo Clinic, Rochester, MN. | |
| Co-investigator, Felbamate, Protocol 242, "Compassionate Use of Felbamate in Patients with Epilepsy". | |
| Co-investigator, Topiramate, Protocols YE, YKT, YKP, YLT. | |
| Co-investigator, Topiramate, Protocol YG, "A Double-Blind, Placebo-Controlled, Parallel, Efficacy and Safety Study of Topiramate in Patients with Partial Epilepsy Followed by Topiramate Single Therapy as Accomplished by the Reduction of Concomitant Dilantin (Phenytoin)". | |
| Co-investigator, Felbamate Protocol 255C, "A Multicenter, Open-Label, Long-Term Evaluation of the Safety of Felbamate in Subjects with Epilepsy". | |
| Principal Investigator, Tiagabine HCI, Protocol M93-090, "Monotherapy Multicenter Trial". | |
| Principal Investigator, Tiagabine HCI, Protocol M91-604, "An Open-Label Extension of Tiagabine HCI in the Treatment of Patients with Partial Seizures", The Ohio State University Hospitals, Columbus, Ohio | |
| Principal Investigator, Vigabatrin Protocol VGPR0101, "Efficacy of Rational Polytherapy with Sabril Versus Carbamazepine Monotherapy in the Management of Patients with Non-refractory Complex Partial Seizures". | |
| Principal Investigator, Tiagabine HCI, Protocol M92-825, "Safety and Efficacy of Tiagabine HCI as Adjuctive Treatment". | |
| Principal Investigator, Losigamone, Protocol LSG-1, "A Randomized, Placebo-Controlled Double-Blind Study of the Efficacy and Safety of Losigamone in Patients with Inadequately Controlled Partial Seizures". | |
| Principal Investigator, Ganaxalone, Protocol 1042-0104, "A Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Antiepileptic Activity of Ganaxalone in Patients Undergoing Evaluation to Determine Suitability for Surgical Treatment of Complex Partial Seizures". | |
| Principal Investigator, Pregabalin, Protocol 1008-009/010, "Double-Blind, Placebo-Controlled, Multicenter Study in Patients with Complex Partial Seizures with or without Secondary Generalization". | |
| Principal Investigator, Pregabalin, Protocol 1008-007, "Pregabalin In-Patient Monotherapy Trial: A Double-Blind, Positive-Controlled, Multicenter Study in Patients with Refractory Partial Epilepsy". | |
| Prinicipal Investigator, Pregabalin Open-Label, Follow-On Safety Trial in Patients with Partial Epilepsy. (Protocol 1008-008) | |
| Principal Investigator, 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. (1008-010) | |
| Principal Investigator, Pregabalin BID Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients with Partial Seizures. (1008-035) | |
| Principal Investigator, SP667 A Multicenter, Double-blind, Randomized, Placebo-Controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200 mg/day, 400 mg/day, 600 mg/day) as Adjunctive Therapy in Subjects with Partial Seizures with or without Secondary Generalization. | |
| Principal Investigator, SP615 An open-label extension trial to determine tolerability and efficacy of long-term oral SPM 927 as adjunctive therapy in patients with partial seizures | |
| Principal Investigator, SP754 A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy and Safety of SPM 927 (400 and 600 mg/day) as Adjunctive Therapy in Subjects with Partial Seizures with or without Secondary Generalization | |
| Principal Investigator, SP756 An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients with Partial Seizures. | |
| Prinicpal Investigator,LAM40112 Double-blind Randomized Trial of Cognitive Effects of LAMICTAL (lamotrigine) versus Topiramate in Epilepsy | |
| Sub-Investigator, LAM40124 An Assessment of Behavioral Changes Associated with Lamotrigine and Levetiracetam in Patients with Epilepsy | |
| Principal Investigator, LAM40117 A MultiCenter Open-Label, Pilot Study of Lamotrigine as Adjunctive Therapy and Monotherapy in Patients with Epilepsy and Comorbid Depressive Symptoms | |
| Principal Investigator, LAM100034: A Multicenter, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects with Partial Seizures | |
| Principal Investigator, LAM100036: A Multicenter, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures | |
| Principal Investigator, SPD433.401 A Multicenter, Open Label, Phase VI Study to Assess the Tolerability, Safety, and Effectiveness of Switching from Carbamazepine Immediate Release and Liquid Formulations to Carbatrol Extended Release Capsules in Epilepsy Subjects within a Community Based Population | |
| Sub-Investigator, 333369-EPY-2003/2006: 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 | |
| Sub-Investigator, E2007-A0001-206: A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E20007 Given as Adjunctive Therapy in Patients with Refractory Partial Seizures | |
| Sub-Investigator, IXL-201-14-189: Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients with Partial Seizures: A Phase II Clinical Trial | |
| Sub-Investigator, IXL-201F-14-189: Talampanel Open-Label Adjunctive Therapy: A Follow-On Study to Determine Long-Term Safety and Efficacy in Patients with Partial Seizures | |
| Sub-Investigator, N01191: An open-label, exploratory, multicenter, dose-escalation study examining the efficacy, safety and tolerability of UCB 44212 | |
| Sub-Investigator, N01192: An open-label, exploratory, multicenter, dose-escalation study examining the efficacy, safety and tolerability of UCB 44212 | |
| Principal Investigator, Neurodevelopment Effects of Antiepileptic Drugs (NEAD) NIH funded multicenter study | |
| Sub-Investigator, N01193: A multicenter, double-blind, randomized, placebo-controlled, 4 parallel groups, dose-ranging trial evaluating the efficacy and safety of brivaracetam used as adjunctive treatment | |
| Principal Investigator, VXR-RET-E22-301: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Retigabine (1200 mg/day) Used as Adjunctive Therapy in Refractory Epilepsy Patients with Partial-Onset Seizures | |
| 2001- 2002 | Maximum tolerated dose study of SPM927 for partial seizures (SP 607). Schwarz Pharma. |
| 2001-2001 | Piracetam for cortical myoclonus (N01004). UCB Pharma. |
| 2001-2002 | An open-label, multi-center, repeated dose pharmacokinetic study of 20,40, and 60 mg/kg/day of levetiracetam in children (4-12 years of age, inclusive) with refractory partial seizures (N01010). |
| 2002-2002 | Double-blinded, randomized controlled trial of SPM 927 for refractory partial-onset seizures (SP617). Schwarz Pharma. |
| 2002- 2004 | A multi-center, double-blind, randomized, placebo-controlled, parallel group trial to investigate the efficacy and safety of SPM 927 (200 mg/day, 400 mg/day, 600 mg/day) as adjunctive therapy in subjects with partial seizures with or without secondary generalization (SP 667). |
| 2003- 2004 | A MultiCenter Open-Label, Pilot Study of Lamotrigine as Adjunctive Therapy and Monotherapy in Patients with Epilepsy and Comorbid Depressive Symptoms (LAM40117) |
Clinical Trials - Atom Sarkar, M.D., Ph.D. - click here to expand or contract list -
| 1/2006 - 12/2012 | Financial support provided by the Department of Neurological Surgery and the James Cancer Hospital’s Cancer Program (Dardinger Fund) for start-up research funding. The institutional support consists of capital equipment, postdoctoral personnel (2) and lab tech personnel (1), lab expenses for research and laboratory space within the Dardinger Laboratory for Neuro-Oncology and Neurosciences. PI |
| 3/2008 - 3/2009 | Magnet Resonance Imaging and Spectrscopy Using a 7 Tesla MRI Device. Co-Investigator |
| 12/2007 - 12/2009 | A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair with Standard of Care Methods During Spinal Surgery. Confluent Surgical, Inc. |
| Pending 1/2009-1/01/2011 |
Phase I Safety Study Evaluating Hippocampal NPY Gene Transfer in Subjects with Intractable Unilateral Mesial Temporal Lobe Epilepsy. Neurologix. |
Clinical Trials - Bassel F. Shneker, M.D. - click here to expand or contract list -
| 9/2008 - ongoing | Protocol E2007-G000-304: 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 (PI, 2) |
| 7/2008 - ongoing | Protocl A0081047: A double-blind, randomized, multicenter efficacy and safety study of pregabalin (lyrica) as monotherapy in patients with refractory partial seizures (PI, 2) |
| 4/2008 - ongoing | Protocol SP 925: A Multicneter, Open-Label Trial to Assess the Safety and Tolerability of A Single Intravenous Loading Dose Of Lacosamide Followed by Oral Lacosamide Maintenance as Ajdunctive Therapy in Subjects with Partial-Onset Seizures (PI, 8) |
| 4/2008 - ongoing | Protocol SP 926: A Multicneter, Open-Label, Extension Trial to Assess the Long Term Safety and Tolerability of Lacosamide as Ajdunctive Therapy in Subjects with Partial-Onset Seizures (PI, 8) |
| 1/2008 - ongoing | Protocol OV-1012: Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome (PI) |
| 1/2008 - ongoing | Protocol OV-1004: Safety and Effectiveness of Open-Label Clobazam in Subjects with Lennox-Gastaut Syndrome (PI) 12/2007 – ongoing Protocol 07-001: 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 (PI, 2) 9/2007 – 8/2008 Protocol N01281: An open-label, long-term follow-up study with Keppra XR for treatment of partial-onset seizures (PI, 1) |
| 9/2007 - 8/2008 | Protocol N01280: A multi-center, double-blind, historical control, randomized conversion to monotherapy study with Keppra XR for treatment of partial onset seizures. (PI, 1) |
| 9/2007 - ongoing | Protocol N01253: An international, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (greater than or equal to 16 to 70 years old) with Partial Onset Seizures (PI, 5) |
| 8/2007 - ongoing | Progesterone therapy for women with Epilepsy (PI, 1) |
| 5/2007 - ongoing | Protocol 1042-0600: A double-blind, randomized, placebo controlled study to evaluate the safety, tolerability, and efficacy of ganaxalone as add-on therapy in adult subjects with epilepsy consisting of uncontrolled partial-onset seizures (PI, 9) |
| 5/2007 - ongoing | Protocol 1042-0601: 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 (PI, 9) |
| 2/2007 - ongoing | Protocol 333369-EPY-3001/3004: A randomized, double-blind, placebo-controlled,parallel-group,multicenetr study to evaluate the efficacy, safety, and tolerability of RWJ-333369 as adjunctive therapy in subjects with partial onset seizures followed by an open-label extension study (PI, 5) |
| 11/2006 - ongoing | Protocol E2080-A001-301: A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients with Refractory Partial Seizures (PI, 18) |
| 11/2006 - ongoing | Protocol E2007-A2001-207: A 14 month, open label extension phase of a double blind, placebo-controlled, dose-escalation parallel-group study of E2007 as an adjunctive therapy in patients with refractory partial seizures (PI, 5) |
| 9/2006 - ongoing | Protocol LAM 30055: A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for The Treatment of Partial Seizures. (PI, 10) |
| 3/2006 - ongoing | Protocol K826-05-3001: A Phase 3, Randomized, Double-Blind, Parallel, Placebo-Controlled, Multicenter 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” (PI, 6) |
| 2/2006 - ongoing | Protocol N01199: An open-label, multicenter, follow-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 100 mg/day in subjects aged 16 years or older suffering from partial onset seizures. (PI, 10) |
| 1/2006- 12/2006 | Protocol N01193: A multicenter, 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, and 50 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 secondarily generalized. (PI, 5) |
| 9/2005 - 1/2007 | Protocol N01192: An open-label, exploratory, multicenter, dose escalation study examining the efficacy, safety, and tolerability of UCB 44212 (seletracetam) used at doses of 10mg, 20 mg, 40 mg and 80 mg b.i.d (total doses of 20-160 mg) administration (orally) in adults subjects (18-65 years) with refractory epilepsy suffering from partial onset seizures who are currently receiving levetiracetam (LEV) but still experiencing seizures (PI, 6) |
| 8/2005 - 9/2006 | Protocol E2007- A001-206: Double-blind, placebo-controlled, dose-escalation, parallel-group study of E2007 given as adjunctive therapy in patients with refractory partial seizures (PI, 5) |
| 7/2005 - 2/2007 | Protocol 333369-EPY-2003/2006: 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 (PI, 2) |
| 5/2005 - 1/2007 | Protocol N01191: An open-label, exploratory, multicenter, dose escalation study examining the efficacy, safety, and tolerability of UCB 44212 used at doses of 10mg, 20 mg, 40 mg and 80 mg b.i.d in adults subjects (18-65 years) with refractory epilepsy suffering from partial onset seizures and treated with 1,2 or 3 approved antiepileptic drugs. (PI, 10) |
| 6/2004 - ongoing | Protocol IXL-201F-14-189: Talampanel Open-Label Adjunctive Therapy: A Follow-on Study To Determine Long-Term Safety and Efficacy in Patients with Partial Seizures. (PI, 11) |
| 5/2004 – 9/2005 | Protocol LAM 40124: An Assessment of Behavioral Changes Associated with Lamotrigine and Levetiracetam in Patients with Epilepsy. (PI, 30) |
| 6/2004 – 8/2005 | Protocol IXL-201-14-189: Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients with Partial Seizures: A Phase II Clinical Trial. (PI, 11) |
| 1/2004 – 9/2005 | Protocol 1008-035: Pregabalin BID Open-Label Add on Trial: An Open Label Multicenter Follow-On Study to Determine Long Term Safety and Efficacy in Patients with Partial Seizures. (PI, 5) |
| 5/2004 – 7/2006 | SP 754: Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy and Safety of SPM927(400 and 600 mg/day) as Adjunctive Therapy in Subjects with Partial Seizures with or without Secondary Generalization (Sub I) |
| 5/2004 – ongoing | SP 756: An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients with Partial Seizures.(Sub I) |
| 8/2002 – ongoing | SPM 927, Protocol SP 615: An Open-label Extension Trial to Determine Tolerability and Efficacy of Long Term Oral SPM 927 as Adjunctive Therapy in Patients with Partial Seizures. (Sub I) |
| 2002 - 9/2005 | Pregabalin Open-Label, Follow-On Safety Trial in Patients with Partial Epilepsy. (Protocol 1008-008). (Sub I) |
| 2002 - 9/2005 | 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. (1008-010). (Sub I) |
| 2003 - 2004 | LAM 40112: Double-blinded Randomized Trial of Cognitive Effects of Lamictal versus Topiramate in Epilepsy (Sub I, 12) |
| 2000 - 2001 | Multi-center, open-label, long-term, follow-up study of the safety and efficacy of ucb LO59 in children with epilepsy (N157). UCB Pharma. |
| 2000 - 2001 | Open-label, follow-on study of pregabalin to determine long-term safety and efficacy in patients with partial seizures (1008-035). Park-Davis. |
| 2000 - 2001 | Open-label extension study of harkoseride as adjunctive therapy in patients with partial seizures (01-202). Harris FRC. |
| 2000 - 2002 | Safety/efficacy of two monotherapy doses of topiramate for newly diagnosed or recurrent epilepsy (106). R.W.Johnson |
| 2000 - 2001 | Double-blinded randomized trial of levetiracetam for intractable partial seizures in children (N159). UCB Pharma |
| 2000 - 2002 | Randomized trial to evaluate the development of polycystic ovarian syndrome in newly diagnosed epilepsy patients initiating lamotrigine vs. valproate (30007). Glaxo Wellcome. |
| 2000 - 2001 | Zonisamide dose titration study (501). Elan. |
| 2000 - 2002 | Double-blinded study of Lamictal for seizures in patients 1-24 months old (20006); extension study (20007). |
| 2001 - 2002 | Maximum tolerated dose study of SPM927 for partial seizures (SP 607). Schwarz Pharma. |
| 2001 - 2001 | Piracetam for cortical myoclonus (N01004). UCB Pharma. |
| 2001 - 2002 | An open-label, multi-center, repeated dose pharmacokinetic study of 20,40, and 60 mg/kg/day of levetiracetam in children (4-12 years of age, inclusive) with refractory partial seizures (N01010). |
| 2002 - 2002 | Double-blinded, randomized controlled trial of SPM 927 for refractory partial-onset seizures (SP617). Schwarz Pharma. |
| 2002 - 2004 | A multi-center, double-blind, randomized, placebo-controlled, parallel group trial to investigate the efficacy and safety of SPM 927 (200 mg/day, 400 mg/day, 600 mg/day) as adjunctive therapy in subjects with partial seizures with or without secondary generalization (SP 667). |
| 2003 - 2004 | A MultiCenter Open-Label, Pilot Study of Lamotrigine as Adjunctive Therapy and Monotherapy in Patients with Epilepsy and Comorbid Depressive Symptoms (LAM40117) |
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