Menstrual Migraine
Conditions
Brief summary
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.
Interventions
DRUGRimegepant
Rimegepant 75 mg ODT for 7 days
DRUGPlacebo Comparator
Matching placebo oral disintegrating tablets for 7 days
DRUGStandard of Care
Standard of care for acute treatment as needed
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Description |
|---|---|---|
| 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 | 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) | 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 | 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 | 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 | 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 | 5 months (5 menstrual cycles) | Change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period |
| Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase | 5 months (5 menstrual cycles) | Change from the Observation Phase in number of moderate-severe migraine days per 5-day perimenstrual period |
| Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase | 5 months (5 menstrual cycles) | Change from baseline in the MiCOAS Cognition score at post-dosing across each cycle |
| Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase | 5 months (5 menstrual cycles) | Change from the Observation Phase in monthly migraine days |
| Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase | 5 months (5 menstrual cycles) | Change from the Observation Phase in monthly headache days |
| Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase | 5 months (5 menstrual cycles) | Change from the Observation Phase in monthly acute migraine-specific medication days |
Countries
Argentina, Canada, China, Denmark, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed