A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants

Sponsor
Pfizer
Study ID
NCT05371652
Phase
PHASE3
Status
Completed

Conditions

  • Acute Migraine

Eligibility Criteria

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

Interventions

Study Details

This trial is to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with migraine

Key Dates

First listed
May 12, 2022
Start date
May 19, 2022
Status verified
Jan 2025
Primary completion
Feb 6, 2024
Completion
Feb 6, 2024

Study Design

Enrollment
241 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rimegepant 75mg Orally Disintegrating Tablets (ODT)
    One rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day)

Primary Outcome Measure

Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From Day 1 of study treatment up to Week 52 of the treatment safety period ]

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