RecruitingPhase 3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

United States723 participantsStarted 2025-03-11

Plain-language 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 menstrual migraine attacks.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase

Timeframe: 5 months (5 menstrual cycles)

Trial details

NCT IDNCT06641466

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-29

Contact for this trial

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

View on ClinicalTrials.gov More Menstrual Migraine trials