Presented at the 2012 AAPM Annual Meeting « Back

Migraine Recurrence Rates: A Case for Standardizing the Definition

Shashidhar Kori, MD, skori@mappharma.com¹, Stewart Tepper, MD², Peter Goadsby, MD PhD³, Michel Ferrari, MD PhD⁴, Richard Lipton, MD⁵, Scott Borland, MS¹, David Dodick, MD⁶, (1) MAP Pharmaceuticals, Mountain View, California, (2) Cleveland Clinic Foundation, Cleveland, Ohio, (3) University of California–San Francisco, San Francisco, California, (4) Leiden University Medical Center, Leiden, Netherlands, (5) Albert Einstein College of Medicine, Bronx, New York, (6) Mayo Clinic, Phoenix, Arizona

Introduction: Recurrence rates are used to assess extended migraine relief; however, definitions of recurrence rates differ. This investigation assessed migraine recurrence in a phase 3 clinical trial of an orally inhaled dihydroergotamine (MAP0004) based on definitions in the literature. Methods: This post hoc analysis compared migraine recurrence rates with MAP0004 and placebo using four published recurrence rate definitions (a through d): (a) numerator = subjects with 2-h pain relief and moderate or severe pain during 2-48 h / denominator = subjects with 2-h pain relief; (b) numerator = same as (a) + subjects with pain relief using rescue medication during 2-48 h / denominator = same as (a); (c) numerator = same as (a) / denominator = number of subjects in modified intent-to-treat population; (d) numerator = same as (b) / denominator = same as (c). Results: In this study, 903 subjects were randomized and 792 who treated ≥1 attack were included in efficacy analysis. Recurrence rates with MAP0004 during 2-24 h were 6.5%, 22.4%, 3.8%, and 13.2% for definitions a through d, respectively. Corresponding rates for placebo were 15.3%, 39.4%, 5.3%, and 13.6%. Rates during 2-48 h with MAP0004 were 10.3%, 30.2%, 6.1%, and 17.7% and rates with placebo were 18.2%, 41.6%, 6.3%, and 14.4%. Conclusions: Recurrence rates, used to assess sustained effects of acute migraine therapies, vary in definition and can be misleading. A standardized definition is needed to make comparisons more meaningful. In a phase 3 study, MAP0004 demonstrated low recurrence rates regardless of definition used.

Funding: Study was sponsored by MAP Pharmaceuticals, Inc.