Trials / Completed
CompletedNCT00144690
E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- —
Summary
The primary objective of this study is to determine the maximal tolerated dose (MTD) of E2007 given twice daily (bid) or once a day (qd) in patients with refractory partial-onset seizures (including secondarily generalized seizures). The secondary objectives are to evaluate the safety, efficacy, concentration-efficacy relationship, and pharmacokinetics of E2007 and the effects of E2007 on the Profile of Mood States (POMS) test.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E2007 (perampanel) | |
| DRUG | Placebo |
Timeline
- Start date
- 2005-03-01
- Primary completion
- 2007-02-01
- Completion
- 2007-02-01
- First posted
- 2005-09-05
- Last updated
- 2015-11-03
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00144690. Inclusion in this directory is not an endorsement.