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
Verified date | April 2024 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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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