A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
Recruiting · NCT06641466 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 18 US states.
- Mayo Clinic Hospital - Phoenix, Arizona, United States
- Mayo Clinic Specialty Building - Phoenix, Arizona, United States
- Mayo Clinic Arizona - Scottsdale, Arizona, United States
- Hope Clinical Research, Inc. - Canoga Park, California, United States
- Axiom Research - Colton, California, United States
- Diablo Clinical Research, Inc. - Walnut Creek, California, United States
- VIN - Aventura - Aventura, Florida, United States
- Velocity Clinical Research, Hallandale Beach - Hallandale, Florida, United States
- Jacksonville Center for Clinical Research - Jacksonville, Florida, United States
- Urban Family Practice Associates - Marietta, Georgia, United States
- Clinical Research Atlanta - Stockbridge, Georgia, United States
- St Luke's Clinic - Neurology - Meridian, Idaho, United States
- Alliance for Multispecialty Research - Medisphere Medical Research Center - Evansville, Indiana, United States
- Michigan Headache & Neurological Institute - Ann Arbor, Michigan, United States
- Clinvest Headlands Llc - Springfield, Missouri, United States
- St. Charles Clinical Research - Weldon Spring, Missouri, United States
- McGill Family Practice - Papillion, Nebraska, United States
- Excel Clinical Research, LLC - Las Vegas, Nevada, United States
- Rochester Clinical Research - Rochester, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States
- Carolina Women's Research and Wellness Center - Durham, North Carolina, United States
- Dayton Center for Neurological Disorders - Centerville, Ohio, United States
- Thomas Jefferson University, Jefferson Headache Center - Philadelphia, Pennsylvania, United States
- Clinical Research of Philadelphia - Philadelphia, Pennsylvania, United States
- Velocity Clinical Research, Providence - East Greenwich, Rhode Island, United States
- Alliance for Multispecialty Research, LLC - Knoxville, Tennessee, United States
- AMR Clinical - Knoxville, Tennessee, United States
- Alliance for Multispecialty Research, LLC - Knoxville, Tennessee, United States
- FutureSearch Trials of Neurology - Austin, Texas, United States
- FutureSearch Trials of Dallas - Dallas, Texas, United States
- Charlottesville Medical Research - Charlottesville, Virginia, United States
- MedStar Health Neurology/MedStar Georgetown Headache Center - McLean, Virginia, United States
- San Peregrino Unidad de Investigación - Aguascalientes, Mexico
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Charité Universitaetsmedizin Berlin - Campus Mitte - Berlin, Germany
- FutureMeds GmbH - Berlin, Germany
- Neurologie Berlin - Berlin, Germany
- Ospedale Bellaria- Azienda USL di Bologna - Bologna, Italy
- Operadora Unidad de Investigación en Salud de Chihuahua - Chihuahua City, Mexico
- PCR Cuautitlán Izcalli - Cuautitlán Izcalli, Mexico
- Clínica Privada Gallia - Córdoba, Argentina
- Azienda Ospedaliera Universitaria Careggi - Florence, Italy
- Rigshospitalet, Glostrup - Glostrup Municipality, Denmark
- Tanaka Neurosurgery&Headache Clinic - Kagoshima, Japan
- Tanaka Neurosurgical Clinic - Kagoshima, Japan
- Hospital La Princesa - Madrid, Spain
- Hospital Universitario La Paz - Madrid, Spain
- Ospedale San Raffaele - Milan, Italy
- Fondazione Istituto Neurologico C. Mondino - Pavia, Italy
- Qingdao Central Hospital, University of Health and Rehabilitation Sciences - Qingdao, China
- IRCCS San Raffaele Roma - Roma, Italy
- Hospital Universitario Virgen Del Rocio - Seville, Spain
- Shanghai East Hospital - Shanghai, China
- Panthera Biopartners - Sheffield - Sheffield, United Kingdom
- Clinical Research Institute S.C. - Tlalnepantla, Mexico
- Hospital Clínico Universitario de Valladolid - Valladolid, Spain
- Region Midtjylland, Regionshospitalet Viborg - Viborg, Denmark
- Hospital Clínico Universitario Lozano Blesa - Zaragoza, Spain
- CaRe Clinic - Red Deer, Alberta, Canada
- Lalitha PVS Institute of Medical Sciences - Guntur, Andhra Pradesh, India
Showing 60 of 123 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →