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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05207865
Other study ID # BHV3000-405
Secondary ID C4951011
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date March 15, 2022
Est. completion date July 5, 2024

Study information

Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 208
Est. completion date July 5, 2024
Est. primary completion date July 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Rimegepant
rimegepant ODT 75mg daily

Locations

Country Name City State
United States The Headache Clinic Alexandria Louisiana
United States Michigan Head Pain & Neurological Institute Ann Arbor Michigan
United States Boston Clinical Trials Boston Massachusetts
United States SPRI Clinical Trials, LLC Brooklyn New York
United States WR-ClinSearch, LLC Chattanooga Tennessee
United States Velocity Clinical Research Cincinnati Ohio
United States CVS HealthHub - East Brunswick East Brunswick New Jersey
United States OK Clinical Research, LLC Edmond Oklahoma
United States Advanced Investigative Medicine, Inc. Hawthorne California
United States CVS HealthHub - Lawrenceville Lawrenceville New Jersey
United States Phoenix Medical Research, LLC Miami Florida
United States Velocity Clinical Research - North Hollywood North Hollywood California
United States Clinical Research Philadelphia, LLC Philadelphia Pennsylvania
United States Elite Clinical Studies, LLC Phoenix Arizona
United States CVS HealthHUB - Runnemede Runnemede New Jersey
United States VIP Trails San Antonio Texas
United States VIP Trials San Antonio Texas
United States Tidewater Integrated Medical Research Virginia Beach Virginia
United States Chase Medical Research, LLC Waterbury Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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