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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPfizer

About 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Rimegepant
  • Placebo Comparator
  • Standard of Care
  • Rimegepant

Treatment groups

723 Participants
are divided into 4 treatment groups

Sponsors and collaborators