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

NCT ID: NCT07301008

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-09
• Study Completion Date: 2027-01-31

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

Keywords

Trigger- induced migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rimegepant 75 MG

Group Type: EXPERIMENTAL

Rimegepant 75 MG

Intervention Type: 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.

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Ailani, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar's Georgetown University Hospital

Locations

MedStar Health: Neurology at McLean

McLean, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yemisrach Tadesse

Role: CONTACT

Phone: 3015708508

Email: yemisrach.g.tadesse@medstar.net

Facility Contacts

Yemisrach Tadesse

Role: primary

Other Identifiers

STUDY00008797

Identifier Type: -

Identifier Source: org_study_id