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

NCT07301008 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00008797
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity

  Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity occurs within 24 hours

  24 hour post dose

Secondary Outcomes (3)

• Percentage of preemptive treatments with rimegepant

  24 hour, 48 hour post dose

• Patient satisfaction with preemptive treatment with rimegepant

  At the end of the study completion( 2 month after enrollment)

• The effect of preemptive treatment with rimegepant on Patient Global Impression of Change (PGIC)

  At the end of study completion( 2 months after enrollement)

Study Arms (1)

Rimegepant 75 MG

EXPERIMENTAL

Drug: Rimegepant 75 MG

Interventions

Rimegepant 75 MG 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.

Rimegepant 75 MG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Pfizer: collaborator

Study Sites (1)

MedStar Health: Neurology at McLean

McLean, Virginia, 22101, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jessica Ailani, MD

  MedStar's Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yemisrach Tadesse

CONTACT

3015708508; yemisrach.g.tadesse@medstar.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: December 24, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)