Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine

Sponsor
Pfizer
Study ID
NCT04574362
Phase
PHASE3
Status
Completed

Conditions

  • Acute Migraine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    One 75mg orally disintegrating tablet
  • Placebo — DRUG
    Matching placebo

Study Details

This trial is to determine whether BHV3000 (rimegepant) 75mg is safe and effictive as a treatment for acute migraine in Chinese and Korean patients

Key Dates

First listed
Oct 5, 2020
Start date
Oct 22, 2020
Status verified
Mar 2023
Primary completion
Nov 24, 2021
Completion
Dec 16, 2021

Study Design

Enrollment
1,648 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rimegepant 75mg
    One 75mg oral disintegration tablet
  • Placebo Comparator: Placebo
    Matching placebo

Primary Outcome Measure

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

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