Rimegepant for Menstrual migraine

Inclusion criteria

• {"criterion_text":"- Female participants ≥18 to ≤45 years who have regular menstrual cycles ≥24 days and ≤34 days and are able to reliably (±3 days) predict the onset of menses in the opinion of the investigator based on participant history."}
• {"criterion_text":"- 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 for migraine with or without aura."}
• {"criterion_text":"- A history of menstrual migraine attacks of at least 3 months: Patient-reported history of experiencing at least 1 migraine attack during the PMP (ie, Days -2 to +3 of the menstrual cycle where Day 1 is the onset of menses) in at least 2 out of 3 menstrual cycles immediately prior to screening."}
• {"criterion_text":"- If the participant is receiving a permitted background continuous prophylactic migraine medication (maximum of a single non-CGRP treatment), 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."}
• {"criterion_text":"- Women who use oral contraceptive tablets as their means of contraception are eligible to participate providing the dose of the contraceptive tablets has been stable for ≥2 months prior to screening and is not expected to change during participation in the study. Women who use IUD as their means of contraception are also eligible if the device had been placed for at least 3 months."}

Exclusion criteria

• {"criterion_text":"- Greater than >6 migraine days per month that are outside of the PMP in the 3 months prior to Screening."}
• {"criterion_text":"- A diagnosis of chronic migraine or a history of >14 headache days per month on average, in the 3 months prior to Screening."}
• {"criterion_text":"- History of retinal migraine, basilar migraine or hemiplegic migraine."}
• {"criterion_text":"- History of any trigeminal autonomic cephalalgia."}
• {"criterion_text":"- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study."}
• {"criterion_text":"- Systolic blood pressure >150 mmHg or >100 mmHg diastolic after 10 minutes of rest at the Screening Visit."}
• {"criterion_text":"- Other pain syndromes, or significant neurological disorders (other than migraine), or other medical conditions that, in the Investigator’s opinion, interfere with study assessments of safety or efficacy."}
• {"criterion_text":"- History of treatment for, or evidence of, alcohol or drug abuse within the past 12 months, participants who have met DSM-V criteria for any significant substance use disorder within the past 12 months prior to the Screening Visit, or participants with a positive drug screen for drugs of abuse that in the investigator’s judgment is medically significant in that it would impact the safety of the participant of the interpretation of the results of the study."}
• {"criterion_text":"- Hypersensitivity or other contraindication to any of the components of the study intervention."}

Primary endpoints

• {"endpoint_text":"- Mean change from the OP in number of migraine days per 5-day PMP across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from the Observation Phase (OP) in the number of migraine days per 5-day perimenstrual period (PMP) measured across each cycle of the Double-Blind Treatment (DBT) Phase."}

Secondary endpoints

• {"endpoint_text":"- Mean change from the OP in number of headache days per 5-day PMP across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from the OP in number of headache days per 5-day PMP across each DBT cycle."}
• {"endpoint_text":"- Percentage of participants with ≥50% reduction from the OP in number of migraine days per 5-day PMP across each cycle of the DBT Phase (50% responder).","definition_or_measurement_approach":"Proportion of participants achieving ≥50% reduction versus OP in migraine days per 5-day PMP across each DBT cycle."}
• {"endpoint_text":"- Mean change from the OP in number of acute migraine medication days per 5-day PMP across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from OP in number of days using acute migraine medication per 5-day PMP across each DBT cycle."}
• {"endpoint_text":"- Mean change from the OP in number of acute migraine-specific medication days per 5-day PMP across each cycle of the DBT Phase (based on eDiary response).","definition_or_measurement_approach":"Mean change from OP in number of days using acute migraine-specific medication per 5-day PMP across each DBT cycle; based on electronic diary (eDiary) responses."}
• {"endpoint_text":"- Mean change from the OP in number of migraine days with moderate-severe functional disability per 5-day PMP across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from OP in number of migraine days with moderate–severe functional disability per 5-day PMP across each DBT cycle."}
• {"endpoint_text":"- Mean change from the OP in number of moderate-severe headache days per 5-day PMP across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from OP in number of moderate–severe headache days per 5-day PMP across each DBT cycle."}
• {"endpoint_text":"- Mean change from the OP in number of moderate-severe migraine days per 5-day PMP across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from OP in number of moderate–severe migraine days per 5-day PMP across each DBT cycle."}
• {"endpoint_text":"- Mean change from baseline in the MiCOAS (Migraine Clinical Outcome Assessment System) Cognition score at post-dosing (ie, 1 day after the 7-day dosing period) across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from baseline in MiCOAS cognition score measured 1 day after the 7-day dosing period in each DBT cycle."}
• {"endpoint_text":"- Mean change from the OP in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from OP in monthly migraine days (per cycle, normalized to 28 days) across each DBT cycle."}
• {"endpoint_text":"- Mean change from the OP in monthly headache days (per cycle, normalized to 28-days) across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from OP in monthly headache days (per cycle, normalized to 28 days) across each DBT cycle."}
• {"endpoint_text":"- Mean change from the OP in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the DBT Phase.","definition_or_measurement_approach":"Mean change from OP in monthly acute migraine-specific medication days (per cycle, normalized to 28 days) across each DBT cycle."}

Methods

• Country-specific recruitment arrangements and materials (study brochure, study poster, participant database letter, informed consent flipchart) provided for Denmark, Germany, Italy, Netherlands, Poland, Spain.
• Pratia prescreening tool (Germany) — prescreening implementation referenced in recruitment documents.
• FutureMeds recruitment texts and prescreening/recruitment materials (Germany, Spain, Netherlands, Poland) referenced in recruitment documents.
• Use of participant database letters to invite potential participants (country-specific).

Denmark

Earliest CTIS Part Ii Submission Date

26-09-2025

Latest Decision Or Authorization Date

06-10-2025

Processing Time Days

10

Number Of Sites

2

Number Of Participants

3

Italy

Earliest CTIS Part Ii Submission Date

28-08-2025

Latest Decision Or Authorization Date

10-10-2025

Processing Time Days

43

Number Of Sites

7

Number Of Participants

10

Netherlands

Earliest CTIS Part Ii Submission Date

09-09-2025

Latest Decision Or Authorization Date

07-10-2025

Processing Time Days

28

Number Of Sites

3

Number Of Participants

4

Germany

Earliest CTIS Part Ii Submission Date

02-07-2025

Latest Decision Or Authorization Date

16-10-2025

Processing Time Days

106

Number Of Sites

4

Number Of Participants

9

Poland

Earliest CTIS Part Ii Submission Date

05-09-2025

Latest Decision Or Authorization Date

10-10-2025

Processing Time Days

35

Number Of Sites

8

Number Of Participants

41

Spain

Earliest CTIS Part Ii Submission Date

05-09-2025

Latest Decision Or Authorization Date

10-10-2025

Processing Time Days

35

Number Of Sites

9

Number Of Participants

29

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

sponsorDuties codes: [4]

Name

Syneos Health Inc.

Responsibilities

sponsorDuties codes: [1,5]

Name

Almac Clinical Services Limited

Responsibilities

sponsorDuties codes: [14]

Name

Fisher Clinical Services Inc.

Responsibilities

Study equipment provision

Name

WCG Clinical Inc.

Responsibilities

Scale training management

Name

Signant Health Global LLC

Responsibilities

Electronic COA (eCOA) support services, eConsent

Third parties

• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [1,5]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Study equipment provision","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Scale training management (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Electronic COA (eCOA) support services, eConsent","organisation_type":"Pharmaceutical company"}