Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

Phase 2 Completed 1026 enrolled Pfizer

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the Phase 3 clinical trials.

Timeline

Start: 2011-10
Primary completion: 2012-05
Completion: 2012-05

Outcome

Met primary endpoint

paper and 300 mg (29.7%, P = 0.002) groups and the sumatriptan group (35%, P < 0.001) had pain freedom at two hours post-dose versus placebo (15.3%). PMID 23965396 ↗

Publications

Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014 Feb;34(2):114-25. doi: 10.1177/0333102413500727. Epub 2013 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rimegepant	Small molecule	10 mg	Oral
Subject	Rimegepant	Small molecule	25 mg	Oral
Subject	Rimegepant	Small molecule	75 mg	Oral
Subject	Rimegepant	Small molecule	150 mg	Oral
Subject	Rimegepant	Small molecule	300 mg	Oral
Subject	Rimegepant	Small molecule	600 mg	Oral
Comparator	Sumatriptan	Unknown	100 mg	Oral