NCT00231595

A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of Topiramate in the Prophylaxis of Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 768 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate (50 milligrams\[mg\], 100mg, and 200mg per day) compared with placebo in the prevention of migraine. The study will also assess the dose response relationship and the efficacy of treatment with topiramate versus placebo on Health-Related Quality of Life.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of three different doses of topiramate (50mg, 100mg, and 200mg daily) in migraine prophylaxis. The study consists of five phases: Baseline (determination of whether patients meet the eligibility criteria and tapering of any migraine medication patients are already taking), Double-Blind (patients receive either 50 milligrams\[mg\], 100mg, 200mg of topiramate, or placebo), Blinded Transition Phase (doses of study medication are adjusted over 7 weeks in preparation for the Open-Label Extension Phase), Open-Label Extension Phase (patients continue the study medication in open-label manner for up to 6 months; doses are adjusted to maximize effectiveness and minimize side effects), Taper/Exit Phase (study medication is slowly discontinued over 2 weeks). The primary study hypothesis is that one or more of the three doses of topiramate (50, 100, 200 mg/day) will be superior to placebo in the prophylaxis of migraine based on the change in monthly (28 day) migraine period rate from the Prospective Baseline Period to the Double-Blind Phase. Topiramate tablets (50milligrams \[mg\], 100mg, 200mg, or placebo) taken by mouth as twice-daily regimen during the 26-week Double-Blind Phase. Doses are adjusted and continued during the 6 month Open-Label Extension Phase after which they are tapered over 2 weeks.

Conditions

• Migraine
• Common Migraine
• Classic Migraine
• Headache

Interventions

Type	Name	Description
DRUG	topiramate

Timeline

• Start date: 2001-03-01
• Completion: 2002-11-01
• First posted: 2005-10-04
• Last updated: 2010-11-19