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
- Rimegepant 75mg Orally Disintegrating Tablets (ODT) — DRUGOne rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day) at the time of their migraine attack
Study Details
This trial is to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with migraine
Key Dates
- 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 ]
Related coverage on Hipa.ai
- Rimegepant: Long-Term Safety Data for Acute Migraine in Chinese ParticipantsRimegepant · Feb 20, 2025 · ClinicalTrials.gov