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

NCT05207865

CompletedPhase 4

Sponsor: Pfizer

Conditions: Migraine, Episodic Migraine, Phonophobia, Photophobia

Interventions: Rimegepant

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (19)

Phoenix, Arizona, United States
Hawthorne, California, United States
North Hollywood, California, United States
Waterbury, Connecticut, United States
Miami, Florida, United States
Alexandria, Louisiana, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
East Brunswick, New Jersey, United States
Lawrenceville, New Jersey, United States
Runnemede, New Jersey, United States
Brooklyn, New York, United States
Cincinnati, Ohio, United States
Edmond, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Chattanooga, Tennessee, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Virginia Beach, Virginia, United States