Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
Part of paid clinical trials in McLean, Virginia.
- Sponsor
- Medstar Health Research Institute
- Study ID
- NCT07301008
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Migraine
- Trigger Induced Migraine
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rimegepant 75 MG — DRUGThe interventional product is rimegepant ODT 75 mg. Rimegepant 75mg ODT will be given 2 hours prior to a trigger exposure for exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours rimegepant will be dosed 2 hours prior to trigger exposure. For weekend or let down headache and changes in sleep pattern, rimegepant will be dosed the night before. The maximum dose in a 24-hour period is 75mg.
Study Details
Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Acceptable triggers for the study will include exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or stress let-down headache.
Key Dates
- Start date
- Sep 9, 2025
- Status verified
- Dec 2025
- Primary completion
- Sep 30, 2026
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: Rimegepant 75 MG
Primary Outcome Measure
Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity [ Time Frame: 24 hour post dose ]
Central Contacts
- Yemisrach Tadesse3015708508
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MedStar Health: Neurology at McLean | McLean | Virginia | 22101 | Jessica Ailani, MD (PRINCIPAL_INVESTIGATOR) |
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