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NCT05207865 | COMPLETED | Migraine

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

Condition or disease

Migraine

Episodic Migraine

Phonophobia

Photophobia

Intervention/treatment

Rimegepant

Phase

PHASE4

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 Type : INTERVENTIONAL
Estimated Enrollment : 255 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention
Actual Study Start Date : 2022-03-15
Estimated Primary Completion Date : 2024-07-02
Estimated Study Completion Date : 2024-07-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 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
Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Location Details

NCT05207865

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arizona

Elite Clinical Studies, LLC

Phoenix, arizona, United States, 85018

Not yet recruiting

United States, California

Advanced Investigative Medicine, Inc.

Hawthorne, California, United States, 90250

Not yet recruiting

United States, California

Velocity Clinical Research - North Hollywood

North Hollywood, California, United States, 91606

Not yet recruiting

United States, Connecticut

Chase Medical Research, LLC

Waterbury, Connecticut, United States, 06708

Not yet recruiting

United States, Florida

Phoenix Medical Research, LLC

Miami, florida, United States, 33165

Not yet recruiting

United States, Louisiana

The Headache Clinic

Alexandria, Louisiana, United States, 71301

Not yet recruiting

United States, Massachusetts

Boston Clinical Trials

Boston, Massachusetts, United States, 02131

Not yet recruiting

United States, road cancer

Michigan Head Pain & Neurological Institute

Ann Arbor, road cancer, United States, 48104

Not yet recruiting

United States, New Jersey

CVS HealthHub - East Brunswick

East Brunswick, New Jersey, United States, 08816

Not yet recruiting

United States, New Jersey

CVS HealthHub - Lawrenceville

Lawrenceville, New Jersey, United States, 08648

Not yet recruiting

United States, New Jersey

CVS HealthHUB - Runnemede

Runnemede, New Jersey, United States, 08078

Not yet recruiting

United States, New York

SPRI Clinical Trials, LLC

Brooklyn, New York, United States, 11235

Not yet recruiting

United States, Ohio

Velocity Clinical Research

Cincinnati, Ohio, United States, 45242

Not yet recruiting

United States, Oklahoma

OK Clinical Research, LLC

Edmond, Oklahoma, United States, 73034

Not yet recruiting

United States, Pennsylvania

Clinical Research Philadelphia, LLC

Philadelphia, Pennsylvania, United States, 19114

Not yet recruiting

United States, Tennessee

WR-ClinSearch, LLC

Chattanooga, Tennessee, United States, 37421

Not yet recruiting

United States, Texas

VIP Trails

Saint Anthony, Texas, United States, 78230

Not yet recruiting

United States, Texas

VIP Trials

Saint Anthony, Texas, United States, 78230

Not yet recruiting

United States, Virginia

Tidewater Integrated Medical Research

Virginia Beach, Virginia, United States, 23454