Status:
RECRUITING
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
Lead Sponsor:
Pfizer
Conditions:
Menstrual Migraine
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience ...
Eligibility Criteria
Inclusion Criteria:
- Participant has regular menstrual cycles ≥24 days and ≤34 days
- 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
- A history of menstrual migraine attacks of at least 3 months
- 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.
- 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:
- Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
- 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
- History of retinal migraine, basilar migraine or hemiplegic migraine
- Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
- 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
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
723 Patients enrolled
Trial Details
Trial ID
NCT06641466
Start Date
March 11 2025
End Date
March 30 2027
Last Update
April 16 2026
Active Locations (122)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Mayo Clinic Specialty Building
Phoenix, Arizona, United States, 85054
3
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
4
Hope Clinical Research, Inc.
Canoga Park, California, United States, 91303