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

Phase 4

Completed

• Conditions: Phonophobia; Photophobia; Episodic Migraine; Migraine
• Interventions: Drug: Rimegepant

• Registration Number: NCT05207865
• Lead Sponsor: Pfizer

Brief 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.

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-26
• Study Start: 2022-03-15
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Key

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rimegepant	Rimegepant	rimegepant 75 mg ODT daily

Primary Outcome Measures

Name	Time	Method
Safety as measures by, adverse Events that occur in at least 5% of subjects by intensity; related serious adverse events (SAEs); and adverse events lead to study drug discontinuation as well as grade 3 and 4 laboratory abnormalities.	Over a 6 month period

Trial Locations

Locations (19)

Boston Clinical Trials; 🇺🇸 Boston, Massachusetts, United States

Phoenix Medical Research, LLC; 🇺🇸 Miami, Florida, United States

Velocity Clinical Research; 🇺🇸 Cincinnati, Ohio, United States

VIP Trials; 🇺🇸 San Antonio, Texas, United States

Elite Clinical Studies, LLC; 🇺🇸 Phoenix, Arizona, United States

VIP Trails; 🇺🇸 San Antonio, Texas, United States

Advanced Investigative Medicine, Inc.; 🇺🇸 Hawthorne, California, United States

Velocity Clinical Research - North Hollywood; 🇺🇸 North Hollywood, California, United States

SPRI Clinical Trials, LLC; 🇺🇸 Brooklyn, New York, United States

OK Clinical Research, LLC; 🇺🇸 Edmond, Oklahoma, United States

Tidewater Integrated Medical Research; 🇺🇸 Virginia Beach, Virginia, United States

Clinical Research Philadelphia, LLC; 🇺🇸 Philadelphia, Pennsylvania, United States

CVS HealthHub - East Brunswick; 🇺🇸 East Brunswick, New Jersey, United States

Chase Medical Research, LLC; 🇺🇸 Waterbury, Connecticut, United States

The Headache Clinic; 🇺🇸 Alexandria, Louisiana, United States

Michigan Head Pain & Neurological Institute; 🇺🇸 Ann Arbor, Michigan, United States

CVS HealthHUB - Runnemede; 🇺🇸 Runnemede, New Jersey, United States

WR-ClinSearch, LLC; 🇺🇸 Chattanooga, Tennessee, United States

CVS HealthHub - Lawrenceville; 🇺🇸 Lawrenceville, New Jersey, United States