Topiramate intervention to prevent transformation of episodic migraine: The topiramate INTREPID study

Richard B. Lipton, Stephen Silberstein, David Dodick, Roger Cady, Fred Freitag, Ninan Mathew, David M. Biondi, Steven Ascher, William H. Olson, Joseph Hulihan

Research output: Contribution to journalArticle

32 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)18-30
Number of pages13
JournalCephalalgia
Volume31
Issue number1
DOIs
StatePublished - Jan 1 2011

Keywords

  • Topiramate
  • chronic
  • migraine
  • preventive treatment
  • transformation

ASJC Scopus subject areas

  • Clinical Neurology

Fingerprint Dive into the research topics of 'Topiramate intervention to prevent transformation of episodic migraine: The topiramate INTREPID study'. Together they form a unique fingerprint.

  • Cite this

    Lipton, R. B., Silberstein, S., Dodick, D., Cady, R., Freitag, F., Mathew, N., Biondi, D. M., Ascher, S., Olson, W. H., & Hulihan, J. (2011). Topiramate intervention to prevent transformation of episodic migraine: The topiramate INTREPID study. Cephalalgia, 31(1), 18-30. https://doi.org/10.1177/0333102410372427