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RecruitingNCT07301008RIMUpdated Dec 24, 2025

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

A Phase 4 interventional study of Rimegepant 75 MG in Migraine and Trigger Induced Migraine, sponsored by Medstar Health Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Medstar Health Research Institute · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year later.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Migraine
  • Trigger Induced Migraine

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Keywords

  • Trigger- induced migraine
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Rimegepant 75 MG

    Drug: Rimegepant 75 MG

Interventions

  • DrugRimegepant 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.

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What researchers measure

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

    Time frame: 24 hour post dose

Secondary outcomes

  1. 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

    Time frame: 24 hour, 48 hour post dose

  2. 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

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

  3. 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.

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

07

Study locations

1 of 1 sites recruiting
  • MedStar Health: Neurology at McLean
    McLean, Virginia 22101, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07301008
Lead sponsor
Medstar Health Research Institute
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Dec 24, 2025
Start date
Sep 9, 2025
Primary completion
Sep 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Dec 24, 2025

Study contacts

Yemisrach Tadesse
Contact
yemisrach.g.tadesse@medstar.net
3015708508
Jessica Ailani, MD
principal investigator · MedStar's Georgetown University Hospital

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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