A Study to Find Out if the Medicine Called Rimegepant is Safe for Adults in India (NCT07685769) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study to Find Out if the Medicine Called Rimegepant is Safe for Adults in India
60 participantsStarted 2026-07-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years of age or older who meet the reproductive criteria.
. Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
. Headache has at least 2 of the following 4 characteristics:
. During headache, at least 1 of the following:
Nausea and/or vomiting
. Not better accounted for by another ICHD-3 diagnosis.
Exclusion criteria
. 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.
. Any of the following:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-emergent adverse events (TEAEs)
. Current use of any prohibited concomitant medication(s).
. History of use of ergotamine medications or triptans for greater than/equal to 10 days per month on a regular basis for greater than/equal to 3 months, or history of non-narcotic analgesic intake for greater than/equal to 15 days per month for greater than/equal to 3 months (eg, acetaminophen, non-steroidal anti-inflammatory drugs \[NSAIDs\], gabapentin) for other pain indications.
. Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days or 5 half-lives of investigational drug (whichever is longer) prior to Baseline Visit. Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days or 5 half-lives (whichever is longer) prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.
. ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:
. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.