Status:
COMPLETED
Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
Lead Sponsor:
Pfizer
Conditions:
Migraine
Episodic Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 m...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2024
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT05207865
Start Date
March 15 2022
End Date
July 2 2024
Last Update
September 3 2025
Active Locations (19)
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1
Elite Clinical Studies, LLC
Phoenix, Arizona, United States, 85018
2
Advanced Investigative Medicine, Inc.
Hawthorne, California, United States, 90250
3
Velocity Clinical Research - North Hollywood
North Hollywood, California, United States, 91606
4
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708