A Study to Find Out if the Medicine Called Rimegepant is Safe for Adults in India

Sponsor
Pfizer
Study ID
NCT07685769
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acute Treatment of Migraine

Eligibility Criteria

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

Interventions

Study Details

This is a multicenter, single-arm, open-label Phase 4 study evaluating the safety and tolerability of rimegepant 75 mg orally disintegrating tablet (ODT) for the acute treatment of migraine (with or without aura) in adult patients in India who have had an insufficient response, intolerance, or contraindication to triptans. It will enroll approximately 60 participants.

Key Dates

First listed
Jul 6, 2026
Start date
Jul 24, 2026
Status verified
Aug 2026
Primary completion
Jan 4, 2028
Completion
Jan 4, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Rimegepant 75 mg ODT
    Rimegepant 75 mg ODT (1 tablet) PRN at the time of migraine attack

Primary Outcome Measure

Incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 28 days ]

Central Contacts

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