Clinical Trial: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

OBJECTIVES:

I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.

Detailed Summary:

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.

Sponsor: National Center for Research Resources (NCRR)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Office of Rare Diseases (ORD)

Dates:
Date Received: February 24, 2000
Date Started: November 1993
Date Completion:
Last Updated: June 23, 2005
Last Verified: December 2001