Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Explore the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures|
- Percentage of Responders During the Maintenance Phase [ Time Frame: Day 85 through Day 112 ] [ Designated as safety issue: No ]A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase.
- Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF [ Time Frame: Baseline, Day 85 through Day 112 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||March 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
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 Comparator: Placebo
Matching placebo once daily for 16 weeks (Days 1 to 112)
|P. Stradina Clinical University Hospital|
|Riga, Latvia, LV-1002|
|Riga, Latvia, LV-1038|
|Study Director:||Julia Yang, MD, MBA||Eisai Inc.|