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

Conditions

• Acute Treatment of Migraine
• Migraine

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Rimegepant — DRUG
  Rimegepant capsules
• Placebo — DRUG
  Rimegepant placebo-matching capsules
• Sumatriptan — DRUG
  Rimegepant matching sumatriptan and Rimegepant matching placebo capsules

Study Details

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.

Key Dates

Start date

Oct 31, 2011

Status verified

Dec 2022

Primary completion

May 31, 2012

Completion

May 31, 2012

Study Design

Enrollment

1,026 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment A: Rimegepant, 10 mg
  Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
• Experimental: Treatment B: Rimegepant, 25 mg
  Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
• Experimental: Treatment C: Rimegepant, 75 mg
  Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
• Experimental: Treatment D: Rimegepant, 150 mg
  Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
• Experimental: Treatment E: Rimegepant, 300 mg
  Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
• Experimental: Treatment F: Rimegepant, 600 mg
  Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
• Placebo Comparator: Treatment P: Rimegepant Placebo-Matching Capsules
  Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
• Active Comparator: Treatment G: Sumatriptan 100 mg
  Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.

Primary Outcome Measure

Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose [ Time Frame: Baseline, 2 hours post-dose ]

Locations (41)

Find similar trials in Scottsdale, AZ

Related Studies

• Quality Improvement and Practice Based Research in Neurology Using the EMR
  PHASE4 · Enrolling By Invitation · Endeavor Health · Evanston, Illinois
• Pain Biomarker Study
  PHASE1 · Enrolling By Invitation · The University of Texas Health Science Center, Houston · Houston, Texas
• Mind Body Balance for Pediatric Migraine
  Recruiting · Children's Hospital Medical Center, Cincinnati · Aurora, Colorado
• Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
  PHASE3 · Recruiting · Pfizer · Scottsdale, Arizona