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

Pfizer

Status and phase

Active, not recruiting

Phase 4

Conditions

Photophobia

Migraine

Phonophobia

Episodic Migraine

Treatments

Drug: Rimegepant

Study type

Interventional

Funder types

Industry

Identifiers

NCT05207865

BHV3000-405

C4951011 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

208 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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