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.
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.
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
Single group
Rimegepant
DrugRimegepant 75 mg ODT for 7 days
Placebo Comparator
DrugMatching placebo oral disintegrating tablets for 7 days
Standard of Care
DrugStandard of care for acute treatment as needed
Rimegepant
DrugRimegepant 75 mg ODT for acute treatment as needed
Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from Observation Period in the number of migraine days per the 5-day perimenstrual period
Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from the Observation Period in number of headache days per 5-day perimenstrual period
Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder)
Patients with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period
Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period
Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from the Observation Period in number of acute migraine specific medication days per 5-day perimenstrual period
