A Phase 3 interventional study of Rimegepant and Placebo Comparator in Menstrual Migraine, sponsored by Pfizer. Recruiting at 123 sites in 15 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Pfizer · Phase 3, Interventional, and Prevention
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Rimegepant
Drug: Rimegepant
Drug: Placebo Comparator
Drug: Standard of Care
Rimegepant 75 mg ODT for 7 days
Matching placebo oral disintegrating tablets for 7 days
Standard of care for acute treatment as needed
Rimegepant 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
Time frame: 5 months (5 menstrual cycles)
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
Time frame: 5 months (5 menstrual cycles)
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
Time frame: 5 months (5 menstrual cycles)
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
Time frame: 5 months (5 menstrual cycles)
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
Time frame: 5 months (5 menstrual cycles)
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
Change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period
Time frame: 5 months (5 menstrual cycles)
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
Change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period
Time frame: 5 months (5 menstrual cycles)
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
Change from the Observation Phase in number of moderate-severe migraine days per 5-day perimenstrual period
Time frame: 5 months (5 menstrual cycles)
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
Change from baseline in the MiCOAS Cognition score at post-dosing across each cycle
Time frame: 5 months (5 menstrual cycles)
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
Change from the Observation Phase in monthly migraine days
Time frame: 5 months (5 menstrual cycles)
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
Change from the Observation Phase in monthly headache days
Time frame: 5 months (5 menstrual cycles)
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
Change from the Observation Phase in monthly acute migraine-specific medication days
Time frame: 5 months (5 menstrual cycles)
Showing the first 100 of 123 sites across 15 countries.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer