Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

Sponsor
Pfizer
Study ID
NCT05399485
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rimegepant — DRUG
    Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12
  • Placebo — DRUG
    Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12

Study Details

This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.

Key Dates

Start date
Aug 9, 2022
Status verified
Nov 2025
Primary completion
Jan 18, 2024
Completion
Nov 7, 2024

Study Design

Enrollment
496 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Rimegepant
    Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12
  • Placebo Comparator: Placebo
    Randomization Phase: one matching placebo every other day until week 12

Primary Outcome Measure

Mean Change From Baseline in Number of Migraine Days Per Month From Week 9 to 12 of the Double-Blind Treatment (DBT) Phase [ Time Frame: Baseline, Week 9 to Week 12 of the DBT phase ]

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