Preemptive rimegepant for predictable trigger-induced migraine in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label, prospective study at the MedStar Georgetown Headache Center enrolling adults with a ≥1 year history of episodic migraine who report a reliable trigger. After a run-in period to confirm a trigger that provokes migraine in ≥75% of exposures, participants will take a single 75 mg dose of rimegepant before anticipated trigger exposure. The study will track whether preemptive dosing prevents or reduces the severity and duration of post-trigger migraine attacks. Participants must have 2–8 moderate-to-severe migraine attacks per month and remain on stable standard-of-care regimens during the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 .
* Average of 2-8 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the screening visit
* Headache/migraine onset before age 50 years
* Migraine attacks, on average, lasting 4-72 hours if untreated
* At least 48 hours between migraine attacks
* Ability to distinguish migraine attacks from tension or cluster headaches
* Particpants on SOC treatment should be on stable regimen for at least 3 months prior to enrollment and should not change their regimen during the course of the study
* Participant may have been on treatment with Botox or mAbs for the last 6 months
* Participants experience migraine ≥75% of the time following exposure to a trigger during the run-in period. Acceptable triggers 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 weekend/ let-down

Exclusion Criteria:

* Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant every other day (EOD)), or using zavegepant or ubrogepant as an acute treatment
* History of use of narcotic or barbiturate containing medications, including opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) on ≥5 days per month on a regular basis for ≥3 months prior to screening
* Current evidence of uncontrolled, unstable, or recently diagnosed cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes.
* Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
* Women must not be pregnant, lactating or breastfeeding

Where it's running

• MedStar Health: Neurology at McLean
  McLean, Virginia, United States Recruiting

Study contacts

• Principal investigator: Jessica Ailani, MD — MedStar's Georgetown University Hospital
• Study coordinator: Yemisrach Tadesse
• Email: yemisrach.g.tadesse@medstar.net
• Phone: 3015708508

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.