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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by (Responsible Party): | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00700310 |
Purpose
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Partial Seizures |
Drug: perampanel Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 712 |
| Study Start Date: | September 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: perampanel
2 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.
Other Name: E2007
|
| Active Comparator: 2 |
Drug: perampanel
4 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.
Other Name: E2007
|
| Active Comparator: 3 |
Drug: perampanel
8 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.
Other Name: E2007
|
| Placebo Comparator: 4 |
Drug: Placebo
Placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily.
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 138 Study Locations| Study Director: | David Squillacote, M.D. | Eisai Inc. |
More Information
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00700310 History of Changes |
| Other Study ID Numbers: | E2007-G000-306 |
| Study First Received: | June 17, 2008 |
| Last Updated: | October 8, 2011 |
| Health Authority: | European Union: European Medicines Agency United States: Food and Drug Administration |
|
Partial onset seizures E2007 perampanel refractory partial seizures adjunctive therapy |
seizure frequency reduction in seizure frequency safety concomitant AED(s) |
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |