A Study of the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol in the Prevention of Migraine

Summary

The purpose of this study is to evaluate the safety and efficacy of two doses of topiramate (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The study will also assess dose response relationship of topiramate, estimate the relative efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect of migraine prevention with topiramate versus placebo on Health Related Quality of Life.

Timeline

Start

2001-04

Primary completion

—

Completion

2002-12

Outcome

Met primary endpoint

paper TPM 100 mg/d was superior to placebo as measured by reduction in monthly migraine frequency PMID 15316798 ↗

Publications

• Results Diener HC, Tfelt-Hansen P, Dahlof C, Lainez MJ, Sandrini G, Wang SJ, Neto W, Vijapurkar U, Doyle A, Jacobs D; MIGR-003 Study Group. Topiramate in migraine prophylaxis--results from a placebo-controlled trial with propranolol as an active control. J Neurol. 2004 Aug;251(8):943-50. doi: 10.1007/s00415-004-0464-6.

Drugs

Indications