Actively Recruiting
Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
Led by Medstar Health Research Institute · Updated on 2025-12-24
60
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
Sponsors
M
Medstar Health Research Institute
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders-3 (ICHD-3)
- Men and women 18 years old or older
- Average of 2-8 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the screening visit
- Headache or migraine onset before age 50 years
- Migraine attacks lasting 4-72 hours if untreated
- At least 48 hours between migraine attacks
- Ability to distinguish migraine attacks from tension or cluster headaches
- Participants on standard of care treatment should be on stable regimen for at least 3 months prior to enrollment and should not change their regimen during the study
- Participant may have been on treatment with Botox or monoclonal antibodies in the last 6 months
- Participants experience migraine at least 75% of the time following exposure to a trigger during the run-in period, with acceptable triggers including exercise, alcohol (less than one drink per day for women and less than two drinks per day for men), air travel lasting no more than 12 hours, sexual activity, fasting lasting no more than 24 hours, stress, or weekend/let-down headaches
You will not qualify if you...
- Using gepants as preventive treatment (atogepant once daily or rimegepant every other day) or using zavegepant or ubrogepant as acute treatment
- History of narcotic or barbiturate containing medication use, including opioids, on 5 or more days per month regularly for 3 or more months prior to screening
- Current uncontrolled, unstable, or recently diagnosed cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes
- Current diagnosis of major depressive disorder requiring atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
- Women who are pregnant, lactating, or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MedStar Health: Neurology at McLean
McLean, Virginia, United States, 22101
Actively Recruiting
Research Team
Y
Yemisrach Tadesse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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