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| Sponsor: | Teva Global Respiratory Research LLC |
|---|---|
| Information provided by: | Teva Global Respiratory Research LLC |
| ClinicalTrials.gov Identifier: | NCT00034814 |
Purpose
To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Talampanel Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial. |
| Enrollment: | 190 |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Enzyme-inducing placebo TID
|
Drug: Placebo
Enzyme-inducing placebo TID
|
|
2: Experimental
Enzyme-inducing Talampanel 35 mg TID
|
Drug: Talampanel
Enzyme-inducing Talampanel 35 mg TID
|
|
3: Experimental
Enzyme-inducing TLP 50mg TID
|
Drug: Talampanel
Enzyme-inducing TLP 50mg TID
|
|
4: Placebo Comparator
Non-enzyme-inducing placebo TID
|
Drug: Placebo
Non-enzyme-inducing placebo TID
|
|
5: Experimental
Non-enzyme-inducing TLP 25mg TID
|
Drug: Talampanel
Non-enzyme-inducing TLP 25mg TID
|
|
6: Experimental
Non-enzyme-inducing TLP 35mg TID
|
Drug: Talampanel
Non-enzyme-inducing TLP 35mg TID
|
A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| UAB Medical Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| Clinical Trials Inc. | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Shands Hospital Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Tampa Research Group | |
| Tampa, Florida, United States, 33613 | |
| DVAM/Neurology (127) | |
| Gainesville, Florida, United States, 32608 | |
| The Cleveland Clinic | |
| Weston, Florida, United States, 33331 | |
| United States, Illinois | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62702 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical CTR | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Missouri | |
| Comprehensive Epilepsy Care Ctr | |
| Chesterfield, Missouri, United States, 63017 | |
| St. John's Medical Research | |
| Springfield, Missouri, United States, 65804 | |
| United States, New Jersey | |
| New Jersey Comprehensive Epilepsy Ctr | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| New York Comprehensive Epilepsy Center, Inc. | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| University Neurology, Inc | |
| Cincinnati, Ohio, United States, 45267 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Orangeburg Medical Hospital | |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, Texas | |
| Baylor Medical Center At Irving | |
| Irving, Texas, United States, 75061 | |
| United States, Virginia | |
| University of Virginia Comprehensive Epilepsy Program | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53705 | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449-5790 | |
| United Kingdom | |
| Western Infirmary | |
| Glasgow, United Kingdom | |
More Information
| Responsible Party: | Teva Neuroscience ( Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development ) |
| Study ID Numbers: | IXL-201-14-189 |
| Study First Received: | May 2, 2002 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00034814 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Epilepsy Nervous System Diseases Central Nervous System Diseases Brain Diseases |
