Trial 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 ODT QD
• Placebo — DRUG
  Placebo ODT to match rimegepant dose QD

Study Details

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

Key Dates

Start date

Feb 27, 2018

Status verified

Dec 2022

Primary completion

Oct 8, 2018

Completion

Oct 15, 2018

Study Design

Enrollment

1,811 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Rimegepant 75 mg
  Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
• Placebo Comparator: Arm 2: Placebo
  Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT 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 (69)

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