Using Rimegepant to prevent menstrual migraines in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic Hospital
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic Specialty Building
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic Arizona
  Scottsdale, Arizona, United States Recruiting
• Hope Clinical Research, Inc.
  Canoga Park, California, United States Recruiting
• Axiom Research
  Colton, California, United States Recruiting
• Diablo Clinical Research, Inc.
  Walnut Creek, California, United States Recruiting

+73 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using fremanezumab to prevent menstrual migraines

  This study is testing if a new migraine treatment called fremanezumab works just as well for menstrual migraines as it does for other types of migraines in women who have frequent headaches.

  Recruiting Insel Gruppe AG, University Hospital Bern · Bern · NCT06659120

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.