Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004776
|Study Chair:||W. Donald Shields||University of California, Los Angeles|