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

Last updated: August 12, 2024
Sponsor: Pfizer
Overall Status: Completed

Phase

4

Condition

Pain

Chronic Pain

Blurred Vision

Treatment

Rimegepant

Clinical Study ID

NCT05207865
BHV3000-405
C4951011
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key 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 ofHeadache 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 priorto the Screening Visit (month is defined as 4 weeks for the purpose of thisprotocol)

  • Subjects ≥ 18 years

Exclusion

Key Exclusion Criteria:

  • Subject history with current evidence of uncontrolled, unstable or recentlydiagnosed cardiovascular disease, such as ischemic heart disease, coronary arteryvasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acutecoronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery,stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior tothe 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 suspectedinfection, hepatitis B or C, or cancer) that, in the investigator's opinion, wouldexpose them to undue risk of a significant adverse event (AE) or interfere withassessments of safety or efficacy during the course of the study

  • History of use of opioid- or barbiturate- (e.g. butalbital) containing medicationfor 4 or more days per month during the 3 months (12 weeks) prior to the ScreeningVisit

  • WOCBP who are unwilling or unable to use an acceptable contraceptive method orabstinence to avoid pregnancy for the entire study and for 28 days after the lastdose of study drug

  • Women who are pregnant or breastfeeding

  • Women with a positive pregnancy test at screening or prior to study drugadministration

Study Design

Total Participants: 255
Treatment Group(s): 1
Primary Treatment: Rimegepant
Phase: 4
Study Start date:
March 15, 2022
Estimated Completion Date:
July 02, 2024

Study 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.

Connect with a study center

  • Elite Clinical Studies, LLC

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California 90250
    United States

    Site Not Available

  • Velocity Clinical Research - North Hollywood

    North Hollywood, California 91606
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Phoenix Medical Research, LLC

    Miami, Florida 33165
    United States

    Site Not Available

  • The Headache Clinic

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • CVS HealthHub - East Brunswick

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • CVS HealthHub - Lawrenceville

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • CVS HealthHUB - Runnemede

    Runnemede, New Jersey 08078
    United States

    Site Not Available

  • SPRI Clinical Trials, LLC

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Velocity Clinical Research

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Aventiv Research, Inc. d/b/a/ Centricity Research

    Dublin, Ohio 43016
    United States

    Site Not Available

  • OK Clinical Research, LLC

    Edmond, Oklahoma 73034
    United States

    Site Not Available

  • Clinical Research Philadelphia, LLC

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • KCA Neurology, PLLC

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • VIP Trails

    San Antonio, Texas 78230
    United States

    Site Not Available

  • VIP Trials

    San Antonio, Texas 78230
    United States

    Site Not Available

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia 23454
    United States

    Site Not Available

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