Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

Sponsor
Pfizer
Study ID
NCT05399459
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rimegepant 25 MG — DRUG
    Single dose of 25 mg orally disintegrating tablet of rimegepant
  • Rimegepant 75 MG — DRUG
    Single dose of 75 mg orally disintegrating tablet of rimegepant
  • Placebo — DRUG
    Matching placebo tablet

Study Details

This study is being conducted to determine the appropriate dose of rimegepant in Japanese subjects, as well as to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the acute treatment of migraine.

Key Dates

Start date
Aug 9, 2022
Status verified
Feb 2025
Primary completion
Jan 19, 2024
Completion
Jan 19, 2024

Study Design

Enrollment
897 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rimegepant 25 mg
    Single dose of 25 mg orally disintegrating tablet of rimegepant
  • Experimental: Rimegepant 75 mg
    Single dose of 75 mg orally disintegrating tablet of rimegepant
  • Placebo Comparator: Placebo
    Matching placebo tablet

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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