Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.

Phase 4 Completed 385 enrolled Ortho-McNeil Neurologics, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether Topiramate is effective in preventing the development of chronic daily headache among patients with episodic migraine headaches.

Timeline

Start: 2005-09
Primary completion: —
Completion: 2007-08

Outcome

Missed primary endpoint

paper Topiramate 100 mg/day did not prevent the development of CDH at six months in subjects with HFEM. PMID 20974598 ↗

paper At month 6, 1.4% of topiramate subjects versus 2.3% of placebo subjects had CDH (p = .589). PMID 20974598 ↗

Publications

Lipton RB, Silberstein S, Dodick D, Cady R, Freitag F, Mathew N, Biondi DM, Ascher S, Olson WH, Hulihan J. Topiramate intervention to prevent transformation of episodic migraine: the topiramate INTREPID study. Cephalalgia. 2011 Jan;31(1):18-30. doi: 10.1177/0333102410372427. Epub 2010 May 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	75 mg	—
Subject	Topiramate	Small molecule	100 mg	—