The Prolonged Use of Topiramate for Preventing Migraine Headaches

Phase 3 Completed 834 enrolled Janssen Pharmaceutica N.V., Belgium

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks.

Timeline

Start: 2003-11
Primary completion: —
Completion: 2006-08

Outcome

Met primary endpoint

paper The mean increase in number of migraine days was greater in the placebo group (1.19 days in 4 weeks, 95% CI 0.71 to 1.66; p<0.0001) PMID 17988947 ↗

paper mean difference between groups -1.09, -1.75 to -0.43; p=0.0011 PMID 17988947 ↗

Publications

Results Diener HC, Agosti R, Allais G, Bergmans P, Bussone G, Davies B, Ertas M, Lanteri-Minet M, Reuter U, Sanchez Del Rio M, Schoenen J, Schwalen S, van Oene J; TOPMAT-MIG-303 Investigators Group. Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2007 Dec;6(12):1054-62. doi: 10.1016/S1474-4422(07)70272-7. Epub 2007 Nov 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	100 mg	Oral
Subject	Topiramate	Small molecule	200 mg	Oral