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

NCT06641466

RecruitingPhase 3

Sponsor: Pfizer

Conditions: Menstrual Migraine

Interventions: Rimegepant, Placebo Comparator, Standard of Care, Rimegepant

Countries: United States, Argentina, Canada, China, Denmark, Germany, India, Italy

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 overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (123)

Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Canoga Park, California, United States
Colton, California, United States
Walnut Creek, California, United States
Aventura, Florida, United States
Hallandale, Florida, United States
Jacksonville, Florida, United States
Marietta, Georgia, United States
Stockbridge, Georgia, United States
Meridian, Idaho, United States
Evansville, Indiana, United States
Ann Arbor, Michigan, United States
Springfield, Missouri, United States
Weldon Spring, Missouri, United States
Papillion, Nebraska, United States
Las Vegas, Nevada, United States
Rochester, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Centerville, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
East Greenwich, Rhode Island, United States
Knoxville, Tennessee, United States
Knoxville, Tennessee, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
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