Rimegepant for Menstrual Migraine

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Pfizer

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for women with a history of menstrual migraines, which are headaches linked to their period. Participants should have experienced these migraines for at least a year and regularly during the last three months. They must have consistent menstrual cycles and if they're on any migraine prevention meds, those doses need to be stable for three months before joining.

Inclusion Criteria

Participant has regular menstrual cycles ≥24 days and ≤34 days

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

I have had migraines for at least 1 year.

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Exclusion Criteria

I have had more than 6 migraine days each month for the last 3 months.

I have chronic migraines or more than 14 headache days a month.

I have a history of specific types of migraines.

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Treatment Details

Interventions

Rimegepant (CGRP Receptor Antagonist)

Trial OverviewThe study is testing Rimegepant's effectiveness when taken around the time of menstruation to prevent migraine attacks. Women in the study will either receive Rimegepant, standard care treatments or a placebo without knowing which one they're getting, to compare results fairly.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment DosingExperimental Treatment1 Intervention

Group II: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day DosingExperimental Treatment1 Intervention

Group III: Standard of CareActive Control1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention