drugset / Trial / NCT01430442

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

NCT01430442

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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications