NCT01430442

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

Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,026 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Intervention Model: Parallel Versus Comparator + Placebo

Conditions

• Migraine
• Acute Treatment of Migraine

Interventions

Type	Name	Description
DRUG	Rimegepant	Rimegepant capsules
DRUG	Placebo	Rimegepant placebo-matching capsules
DRUG	Sumatriptan	Rimegepant matching sumatriptan and Rimegepant matching placebo capsules

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-09-08
• Last updated: 2023-02-28
• Results posted: 2020-09-03

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study