Trials / Completed
CompletedNCT00700310
Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 712 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 12 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2009-08-01
- Completion
- 2010-01-01
- First posted
- 2008-06-18
- Last updated
- 2016-01-21
- Results posted
- 2012-11-22
Locations
137 sites across 23 countries: Australia, Bulgaria, Czechia, Estonia, Germany, Hong Kong, Hungary, India, Italy, Latvia, Lithuania, Malaysia, Philippines, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Taiwan, Thailand, Ukraine
Source: ClinicalTrials.gov record NCT00700310. Inclusion in this directory is not an endorsement.