Recruiting

Observational Study

Sponsor:

Medstar Health Research Institute

Code:

NCT07301008

Conditions

Migraine

Trigger Induced Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rimegepant 75 MG

Study Details

Brief summary:

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

Migraine

Trigger Induced Migraine

Study ID

NCT07301008

Start date

Sep 9, 2025

Status verified date

Dec, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Rimegepant 75 MG

Interventions

Rimegepant 75 MG

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.

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 and Locations

Central contacts

Yemisrach Tadesse

3015708508yemisrach.g.tadesse@medstar.net

Locations

MedStar Health: Neurology at McLean

Recruiting

McLean, Virginia, United States, 22101

Contacts

Yemisrach Tadesse

3015708508yemisrach.g.tadesse@medstar.net

Principal Investigator:

Jessica Ailani, MD

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Trigger- induced migraine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-12-24.