C4951063: A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

17 Oct 2025 → ongoing

Decision date (initial)

2025-10-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517121-10-00

ClinicalTrials.gov

NCT06641466

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To confirm the superiority of rimegepant 75 mg ODT versus placebo for the intermittent prevention of menstrual migraine attacks, defined as those occurring during the 5-day PMP, when administered for 7 days per menstrual cycle.

Secondary objectives 5

1. To further establish the superiority of rimegepant 75 mg ODT versus placebo for intermittent prevention of menstrual migraine attacks, defined as those occurring during the 5-day PMP, when administered for 7 days per menstrual cycle.
2. To evaluate the efficacy of rimegepant 75 mg ODT daily versus placebo on measures of monthly migraine frequency derived from the daily headache diary, when administered for 7 days per menstrual cycle.
3. To evaluate the effect of rimegepant 75 mg ODT daily versus placebo on additional efficacy variables over the DBT for the intermittent prevention of menstrual migraine attacks.
4. To evaluate the effect of treatment with rimegepant 75 mg ODT daily versus placebo during the DBT Phase on patient-reported outcome measures of productivity, function, global status, and treatment satisfaction.
5. To evaluate the safety and tolerability of rimegepant 75 mg ODT daily for 7 days per menstrual cycle for intermittent prevention of menstrual migraine attacks.

Conditions and MedDRA coding

Menstrual Migraine

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Food And Drug Administration, European Medicines Agency, European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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 criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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.
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 for migraine with or without aura.
3. A history of menstrual migraine attacks of at least 3 months: Patient-reported history of experiencing at least 1 migraine day 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.
4. 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.
5. 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 9

1. Greater than >6 migraine days per month that are outside of the PMP in the 3 months prior to Screening.
2. A diagnosis of chronic migraine or a history of >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. History of any trigeminal autonomic cephalalgia.
5. 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.
6. Systolic blood pressure >150 mmHg or >100 mmHg diastolic after 10 minutes of rest at the Screening Visit.
7. 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.
8. 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.
9. Hypersensitivity or other contraindication to any of the components of the study intervention.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean change from the OP in number of migraine days per 5-day PMP across each cycle of the DBT Phase.

Secondary endpoints 11

1. Mean change from the OP in number of headache days per 5-day PMP across each cycle of the DBT Phase.
2. 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).
3. Mean change from the OP in number of acute migraine medication days per 5-day PMP across each cycle of the DBT Phase.
4. 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).
5. 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.
6. Mean change from the OP in number of moderate-severe headache days per 5-day PMP across each cycle of the DBT Phase.
7. Mean change from the OP in number of moderate-severe migraine days per 5-day PMP across each cycle of the DBT Phase.
8. 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.
9. Mean change from the OP in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the DBT Phase.
10. Mean change from the OP in monthly headache days (per cycle, normalized to 28-days) across each cycle of the DBT Phase.
11. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 6

Locations

6 EU/EEA countries · 33 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 52 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications