A Study to Find Out if the Medicine Called Rimegepant is Safe for Adults in India
ConditionAcute Treatment of Migraine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
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.
Eligibility criteria
Qualifiers
18 years of age or older who meet the reproductive criteria.
Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated).
Unilateral location
Pulsating quality
Disqualifiers
Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
PHQ-8 total score ≥15
a positive response to item 1 or 2 of the C-SSRS within 30 days prior to Screening;
suicidal ideation associated with actual intent and/or a method or plan at any time in their lifetime: any positive response on items 3, 4 or 5 of the C-SSRS;
Trial design
Treatments tested in this trial
- Rimegepant 75 mg ODT
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov