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Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention

NCT05207865•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine.

Detailed Description

This is a post marketing required study being conducted to further evaluate the long-term safety and tolerability of a more frequent daily dosing regimen of rimegepant for the prevention of episodic migraine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
•Age of onset of migraines prior to 50 years of age
•Migraine attacks, on average, lasting 4 -72 hours if untreated
•Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol)
•Subjects ≥ 18 years

Exclusion Criteria

•Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit.
•Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes.
•The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the study
•History of use of opioid- or barbiturate- (e.g. butalbital) containing medication for 4 or more days per month during the 3 months (12 weeks) prior to the Screening Visit
•WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 28 days after the last dose of study drug
•Women who are pregnant or breastfeeding
•Women with a positive pregnancy test at screening or prior to study drug administration

Locations (19)

Elite Clinical Studies, LLC

Phoenix, Arizona, United States

Advanced Investigative Medicine, Inc.

Hawthorne, California, United States

Velocity Clinical Research - North Hollywood

North Hollywood, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Phoenix Medical Research, LLC

Miami, Florida, United States

The Headache Clinic

Alexandria, Louisiana, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, United States

CVS HealthHub - East Brunswick

East Brunswick, New Jersey, United States

CVS HealthHub - Lawrenceville

Lawrenceville, New Jersey, United States

Key Dates

Start Date

March 15, 2022

Primary Completion Date

July 2, 2024

Completion Date

July 2, 2024

Last Updated

September 3, 2025

Enrollment

441

ACTUAL participants

Conditions

MigraineEpisodic MigrainePhonophobiaPhotophobia

Interventions

Rimegepant

DRUG

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

NCT07018713

Chronic Migraine

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RECRUITINGPHASE3

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

NCT06641466

Menstrual Migraine

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RECRUITINGNA

Mind Body Balance for Pediatric Migraine

NCT04715685

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

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

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.