Clinical trial NCT05207865: Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
Official title: A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Episodic Migraine
Phonophobia
Photophobia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 migraine.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Over a 6 month period
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Hawthorne
country: United States
facility: Advanced Investigative Medicine, Inc.
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research - North Hollywood
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Miami
country: United States
facility: Phoenix Medical Research, LLC
state: Florida
city: Alexandria
country: United States
facility: The Headache Clinic
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: East Brunswick
country: United States
facility: CVS HealthHub - East Brunswick
state: New Jersey
city: Lawrenceville
country: United States
facility: CVS HealthHub - Lawrenceville
state: New Jersey
city: Runnemede
country: United States
facility: CVS HealthHUB - Runnemede
state: New Jersey
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC
state: New York
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: Clinical Research Philadelphia, LLC
state: Pennsylvania
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: San Antonio
country: United States
facility: VIP Trails
state: Texas
city: San Antonio
country: United States
facility: VIP Trials
state: Texas
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: