Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
NCT01430442 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1026
Last updated 2023-02-28
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.
Conditions
- Migraine
- Acute Treatment of Migraine
Interventions
- DRUG
-
Rimegepant
Rimegepant capsules
- DRUG
-
Rimegepant placebo-matching capsules
- DRUG
-
Sumatriptan
Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2012-05-31
- Completion
- 2012-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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