Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
|ClinicalTrials.gov Identifier: NCT00004776|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Lennox-Gastaut Syndrome||Drug: topiramate||Phase 3|
PROTOCOL OUTLINE: This is a randomized, double-blind study. Following a 28-day baseline period, patients are randomly assigned to oral topiramate or placebo. The dose of study medication is titrated over the first 3 weeks; the maintenance dose is administered for the next 5 weeks.
Extended topiramate treatment is available to all patients after randomized therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Study Start Date :||November 1993|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004776
|Study Chair:||W. Donald Shields||University of California, Los Angeles|