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

RecruitingPhase 3Ages 18 Years - 45 YearsFemalePfizer
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Participant has regular menstrual cycles โ‰ฅ24 days and โ‰ค34 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
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What it tests

  • Rimegepant
  • Placebo Comparator
  • Standard of Care
  • Rimegepant
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Where

123 sites
Mayo Clinic Hospital
Phoenix, United States
Mayo Clinic Specialty Building
Phoenix, United States
Mayo Clinic Arizona
Scottsdale, United States
Hope Clinical Research, Inc.
Canoga Park, United States
Axiom Research
Colton, United States
Diablo Clinical Research, Inc.
Walnut Creek, United States
VIN - Aventura
Aventura, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, United States

โ€ฆand 115 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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