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Topiramate intervention to prevent transformation of episodic migraine: the topiramate INTREPID study. Cephalalgia 2011 Jan;31(1):18-30 PMID: 20974598

Pubmed ID

20974598

DOI

10.1177/0333102410372427

Abstract

OBJECTIVE: The study sought to evaluate whether topiramate prevents development of chronic daily headache (CDH, ≥15 headache days per month) in adult subjects with high-frequency episodic migraine (HFEM, 9-14 migraine headache days/month). A secondary objective was to assess the efficacy of topiramate as preventive migraine treatment in this population.

METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study comparing topiramate 100 mg/day and placebo for 26 weeks. The primary efficacy variable was new-onset CDH at month 6. Secondary efficacy measures included migraine and headache days. Adverse events (AEs) were evaluated.

RESULTS: A total of 159 topiramate subjects and 171 placebo subjects were efficacy-evaluable. At month 6, 1.4% of topiramate subjects versus 2.3% of placebo subjects had CDH (p = .589). Compared with placebo, topiramate treatment was associated with statistically significant reductions in mean number of migraine days (6.6 vs. 5.3/28 days; p = .001) and headache days (6.6 vs 5.3/28 days; p = .001). Most commonly reported AEs in the topiramate versus placebo group included paresthesia (32.4% vs. 7.0%), fatigue (14.8% vs. 8.6%), dizziness (11.4% vs. 7.6%) and nausea (10.8% vs. 9.2%).

CONCLUSION: Topiramate 100 mg/day did not prevent the development of CDH at six months in subjects with HFEM. Topiramate was effective in reducing headache days and migraine headache days and generally well tolerated.

Author List

Lipton RB, Silberstein S, Dodick D, Cady R, Freitag F, Mathew N, Biondi DM, Ascher S, Olson WH, Hulihan J

Author

Frederick G. Freitag DO Associate Professor in the Neurology department at Medical College of Wisconsin




Scopus

2-s2.0-79751483735   26 Citations

MESH terms used to index this publication - Major topics in bold

Adult
Double-Blind Method
Female
Fructose
Headache Disorders
Humans
Male
Migraine Disorders
Neuroprotective Agents
Treatment Outcome
jenkins-FCD Prod-331 a335b1a6d1e9c32173c9534e6f6ff51494143916