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Using Rimegepant to prevent menstrual migraines in women

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE

Phase 3 Interventional Pfizer · NCT06641466

This study is testing if rimegepant can help women with a history of menstrual migraines have fewer and less severe headaches during their periods.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment723 (estimated)
Ages18 Years to 45 Years
SexFemale
SponsorPfizer Industry-sponsored
Locations122 sites (Phoenix, Arizona and 121 other locations)
Trial IDNCT06641466 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of rimegepant, a medication, for the intermittent prevention of menstrual migraines in women. Participants will receive either rimegepant or a placebo during the peri-menstrual period. Eligible women must have a history of menstrual migraines and regular menstrual cycles. The study aims to determine if rimegepant can effectively reduce the frequency and severity of migraine attacks during this specific time.

Who should consider this trial

Good fit: Ideal candidates are women with regular menstrual cycles who experience menstrual migraines and have a history of migraine attacks during the peri-menstrual period.

Not a fit: Patients with chronic migraines or those experiencing more than six migraine days per month outside the peri-menstrual period may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the burden of menstrual migraines for women.

How similar studies have performed: Other studies have explored similar approaches for migraine prevention, but the specific use of rimegepant for menstrual migraines is a novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participant has regular menstrual cycles ≥24 days and ≤34 days
2. A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition
3. A history of menstrual migraine attacks of at least 3 months
4. Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening.
5. If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study

Exclusion Criteria:

1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
2. A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening
3. History of retinal migraine, basilar migraine or hemiplegic migraine
4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
5. Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea

Where this trial is running

Phoenix, Arizona and 121 other locations

+72 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Menstrual Migraine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.