Menstrual Migraine
Conditions
Interventions
*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 n
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *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 [Time Frame: 5 months (5 menstrual cycles)] -Change from Observation Period in the number of migraine days per the 5-day perimenstrual period | — |
Secondary
| Measure | Time frame |
|---|---|
| *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 [Time Frame: 5 months (5 menstrual cycles)] -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) [Time Frame: 5 months (5 menstrual cycles)] -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 [Time Frame: 5 months (5 menstrual cycles)] -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 [Time Frame: 5 months (5 menstrual cycles)] -Change from the Observation Period in number of acute migraine specific medication days per 5-day perimenstrual period *Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)] -Change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period *Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)] -Change from the Observation Period in number of moderate-severe headache days per 5- | — |
Countries
Argentina, Canada, China, Denmark, Germany, India, Italy, Japan, Netherlands, Poland, South Korea, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed