Safety and Efficacy Study in Adult Subjects With Acute Migraines

Conditions

• Migraine, With or Without Aura

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rimegepant — DRUG
  75 mg tablet QD
• Placebo — DRUG
  Placebo tablet to match rimegepant dose QD

Study Details

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines

Key Dates

Start date

Jul 18, 2017

Status verified

Feb 2023

Primary completion

Jan 21, 2018

Completion

Jan 26, 2018

Study Design

Enrollment

1,485 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rimegepant 75 mg
  Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
• Placebo Comparator: Placebo
  Participants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

Primary Outcome Measure

Percentage of Participants With Freedom From Pain at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ]

Locations (50)

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