A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Phase 3

Recruiting

• Conditions: Menstrual Migraine
• Interventions: Drug: Rimegepant; Drug: Placebo Comparator; Drug: Standard of Care

• Registration Number: NCT06641466
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Study Start: 2025-03-11
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-27
• Last Update Posted: 2025-10-28
• Primary Completion: 2026-11-29
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 723

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing	Rimegepant	-
Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing	Rimegepant	-
Placebo	Placebo Comparator	-
Standard of Care	Standard of Care	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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-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
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

Trial Locations

Locations (77)

FutureMeds GmbH; 🇩🇪 Berlin, Germany

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Florence, Italy

Instytut Zdrowia Dr Boczarska Jedynak; 🇵🇱 Oświęcim, Lesser Poland Voivodeship, Poland

NZOZ Neuromed M.i M. Nastaj; 🇵🇱 Lublin, Lublin Voivodeship, Poland

Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej; 🇵🇱 Lublin, Lublin Voivodeship, Poland

FutureMeds Warszawa Centrum; 🇵🇱 Warsaw, Masovian Voivodeship, Poland

Dr Sękowska Leczenie Bólu; 🇵🇱 Warsaw, Masovian Voivodeship, Poland

Silmedic; 🇵🇱 Katowice, Silesian Voivodeship, Poland

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Barcelona [barcelona], Spain

FutureMeds Spain Cádiz; 🇪🇸 Chiclana de la Frontera, Cádiz, Spain

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