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NCT07729462

Overview

NCT ID: NCT07729462
Lead Sponsor: PfizerINDUSTRY
Official Title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, RANDOMIZED, 2-ARM STUDY TO INVESTIGATE THE PREVENTION OF CHRONIC MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN PARTICIPANTS 18 YEARS OF AGE OR OLDER
Brief Summary: Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. This study evaluates once daily rimegepant for the preventive treatment of chronic migraine.

After a 28-day observation period without study intervention, eligible participants will be randomized in a 1:1 ratio to receive either rimegepant 75 mg orally disintegrating tablet (ODT) or matching placebo once daily for 12 weeks under double-blind conditions. Participants who remain eligible at the end of the double-blind treatment phase will enter a 12-week open-label treatment period, during which all participants will receive open-label rimegepant 75 mg once daily. During this period, participants may also take an additional rimegepant tablet for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. A 28-day follow-up period completes the approximately 32-week study.

The primary objective of the study is to determine whether once-daily rimegepant is more effective than placebo in reducing monthly migraine days relative to the observation period in adults with chronic migraine. Secondary objectives include evaluating differences between rimegepant and placebo in migraine responder rates, headache severity, acute migraine medication use, quality of life, work productivity, cognitive functioning, and safety and tolerability.

Approximately 400 adults aged 18 years or older with a diagnosis of chronic migraine for at least 1 year will be enrolled at multiple study sites.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Jul 29, 2026Estimated
Primary Completion Date: Sep 12, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Male or female participants ≥18 years of age.

Diagnosis of chronic migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.

History of migraine for at least 1 year before screening.

Migraine onset before 50 years of age and chronic migraine onset before 65 years of age.

Migraine attacks lasting 4 to 72 hours when untreated or unsuccessfully treated.

During the 3 months prior to screening, an average of:

≥15 monthly headache days (MHDs),

including ≥8 monthly migraine days (MMDs),

and ≥1 non-headache day per month.

Completion of the Observation Phase and fulfillment of all protocol-defined eligibility requirements prior to randomization.

Willing and able to comply with study procedures, including completion of the electronic diary.

Exclusion Criteria:

Prior use of rimegepant for migraine prevention.

History of treatment failure of:

2 gepants, or

2 CGRP-targeting biologics, or

1 gepant and ≥1 CGRP-targeting biologic.

Failure of >4 migraine preventive medications, including at least 2 with different mechanisms of action.

Any medical or psychiatric condition, or clinically significant laboratory abnormality, that in the investigator's judgment may increase risk to the participant or interfere with study participation or interpretation of results. This includes, but is not limited to, uncontrolled hypertension or a history of Raynaud's phenomenon.

Pregnant, breastfeeding, planning to become pregnant, or planning to initiate breastfeeding during the study.

Positive amphetamine screening result unless attributable to prescribed stimulant therapy that has been stable for at least 3 months prior to Visit 1 and is expected to remain stable throughout study participation.

Use of investigational products or participation in another clinical study within protocol-defined exclusion windows.

Any other condition that, in the opinion of the investigator or sponsor, would make study participation unsafe or compromise study conduct.

Study Plan

Study Type: Interventional
Phase: Phase 3
Enrollment: 400Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Pfizer CT.gov Call CenterContact
ClinicalTrials.gov_Inquiries@pfizer.com

Similar Studies

Participant Group/Arms

Rimegepant 75 mg orally disintegrating tablet (ODT) once dailyExperimental

Participants will receive rimegepant 75 mg orally disintegrating tablet (ODT) once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month.

Drug: Rimegepant

Matching placebo once daily for 12 weeks during the double-blind treatment phasePlacebo Comparator

Participants will receive matching placebo once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month.

Drug: Placebo