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

Migraine Clinical Trial

Official title:

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

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
• Start date: March 15, 2022
• Est. completion date: July 24, 2024

Study information

• Verified date: January 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• 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 24, 2024
• Est. primary completion date: July 24, 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

Related Conditions & MeSH terms

• Episodic Migraine
• Hyperacusis
• Migraine
• Migraine Disorders
• Phonophobia
• Photophobia

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

External Links

•   To obtain contact information for a study center near you, click here.