Preemptive rimegepant for predictable trigger-induced migraine in adults

Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US

This study will test whether taking a 75 mg dose of rimegepant before a known trigger can prevent migraine attacks in adults who reliably get trigger-induced migraines.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medstar Health Research Institute (other)
• Locations: 1 site (McLean, Virginia)
• Trial ID: NCT07301008 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with episodic migraine for at least one year, 2–8 moderate or severe attacks per month, and a reliably reproducible trigger that causes migraine in ≥75% of exposures are ideal candidates.

Not a fit: People without predictable triggers, those with chronic daily migraine, or those who do not reliably develop a migraine after trigger exposure are unlikely to benefit from preemptive dosing.

Why it matters

Potential benefit: If successful, taking rimegepant before a known trigger could reduce the number or severity of migraine attacks for people with predictable trigger-related migraines.

How similar studies have performed: Rimegepant has proven effective for acute treatment and for preventive monthly use in other trials, but using it preemptively for predictable triggers is a relatively novel approach with limited direct evidence.

Eligibility criteria

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 this trial is running

McLean, Virginia

• 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

Conditions: Migraine, Trigger Induced Migraine, Trigger- induced migraine