Trials / Completed
CompletedNCT00004776
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 10 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 4 Years – 30 Years
- Healthy volunteers
- Not accepted
Summary
OBJECTIVES: I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | topiramate |
Timeline
- Start date
- 1993-11-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004776. Inclusion in this directory is not an endorsement.