RECRUITINGPhase 3INTERVENTIONAL
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Rimegepant
Rimegepant 75 mg ODT for 7 days
DRUG
Placebo Comparator
Matching placebo oral disintegrating tablets for 7 days
DRUG
Standard of Care
Standard of care for acute treatment as needed
DRUG
Rimegepant
Rimegepant 75 mg ODT for acute treatment as needed
Locations (20)
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, LLC
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States