A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches

Phase 3 Completed 328 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Ortho-McNeil Neurologics, Inc. · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo for the prevention of headaches in patients with chronic migraine. Topiramate has been approved to prevent migraine headaches as well as in the treatment of epilepsy.

Timeline

Start: 2003-09
Primary completion: —
Completion: 2005-04

Outcome

Met primary endpoint

paper Topiramate treatment resulted in a statistically significant mean reduction of migraine/migrainous headache days (topiramate -6.4 vs placebo -4.7, P= .010) PMID 17300356 ↗

Publications

Results Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N, Brandes JL, Bigal M, Saper J, Ascher S, Jordan DM, Greenberg SJ, Hulihan J; Topiramate Chronic Migraine Study Group. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007 Feb;47(2):170-80. doi: 10.1111/j.1526-4610.2006.00684.x.

Drugs

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