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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00334958 |
Purpose
The primary objective of this study is to evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult patients with refractory partial onset seizures currently inadequately treated with a maximum of three stable antiepileptic medications. Secondary objectives are to evaluate the effect of rufinamide on secondary and exploratory outcomes, to confirm the safety profile of rufinamide, and to assess the relationship between rufinamide plasma concentration and efficacy.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Placebo Drug: Rufinamide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures |
| Estimated Enrollment: | 408 |
| Study Start Date: | September 2006 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Placebo
400 mg tablet.
|
| Active Comparator: 2 |
Drug: Rufinamide
Rufinamide 400 mg tablet
Other Name: E2080
|
Eligibility| Ages Eligible for Study: | 12 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA:
Contacts and Locations
Show 77 Study Locations| Study Director: | Francesco Bibbiani, M.D. | Eisai Inc. |
More Information
| Responsible Party: | Francesco Bibbiani, M.D., Eisai Medical Research Inc. |
| ClinicalTrials.gov Identifier: | NCT00334958 History of Changes |
| Other Study ID Numbers: | E2080-A001-301 |
| Study First Received: | June 7, 2006 |
| Last Updated: | August 4, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |