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

Eligibility Criteria

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

Interventions

  • Rimegepant 75 MG — DRUG
    The 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

Locations (1)

FacilityCityStateZIPSite coordinators
MedStar Health: Neurology at McLeanMcLeanVirginia22101
Yemisrach Tadesse
3015708508
Jessica Ailani, MD (PRINCIPAL_INVESTIGATOR)

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