Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||November 1993|
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 Chair:||W. Donald Shields||University of California, Los Angeles|