Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures
- Registration Number
- NCT00416195
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel group study to determine the maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients each. One group will be patients who take concomitant inducing AEDs (anti-epileptic drugs) and the second group will be patients who do not take concomitant inducing AEDs. In each group, 18 patients will receive E2007 (dose escalating to a maximum of 12 mg per day) and six will receive placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E2007 E2007 2 mg E2007 once daily for 2 weeks (Days 1 to 14), then 4 mg E2007 once daily for 2 weeks (Days 15 to 28), then 6 mg E2007 once daily for 2 weeks (Days 29 to 42), then 8 mg E2007 once daily for 2 weeks (Days 43 to 56), then 10 mg E2007 once daily for 2 weeks (Days 57 to 70), then 12 mg E2007 once daily for 6 weeks (Days 71 to 112). Placebo Placebo Matching placebo once daily for 16 weeks (Days 1 to 112)
- Primary Outcome Measures
Name Time Method Percentage of Responders During the Maintenance Phase Day 85 through Day 112 A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase.
- Secondary Outcome Measures
Name Time Method Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF Baseline, Day 85 through Day 112
Trial Locations
- Locations (2)
Hospital Gailezers
🇱🇻Riga, Latvia
P. Stradina Clinical University Hospital
🇱🇻Riga, Latvia