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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine; Trigger Induced Migraine
• Intervention / Treatment: Drug: Rimegepant 75 MG

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yemisrach Tadesse; Phone Number: 3015708508; Email: yemisrach.g.tadesse@medstar.net

Study Locations

• United States
  • Virginia
    • McLean, Virginia, United States, 22101
      • Recruiting
      • MedStar Health: Neurology at McLean
      • Principal Investigator: Jessica Ailani, MD
      • Contact: Yemisrach Tadesse; Phone Number: 3015708508; Email: yemisrach.g.tadesse@medstar.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Rimegepant 75 MG

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of preemptive treatments with rimegepant	Percentage of preemptive treatments with rimegepant in which migraine occurs within 24 hours; Percentage of preemptive treatments with rimegepant that require rescue medication within 24 hours; Percentage of preemptive treatments with rimegepant that result in acute medication use within 48 hours of treatment	24 hour, 48 hour post dose
Patient satisfaction with preemptive treatment with rimegepant	Patient satisfaction with preemptive rimegepant treatment will be assessed in the case report form using a Likert scale	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)	The effect of preemptive treatment with rimegepant on Patient Global Impression of Change (PGIC) using a graded scale of 1-7.	At the end of study completion( 2 months after enrollement)

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: Pfizer
• Investigators: Principal Investigator: Jessica Ailani, MD, MedStar's Georgetown University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 20, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Trigger- induced migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; rimegepant sulfate
• Other Study ID Numbers: STUDY00008797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No