Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
NCT ID: NCT05207865
Last Updated: 2025-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
441 participants
INTERVENTIONAL
2022-03-15
2024-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rimegepant
rimegepant 75 mg ODT daily
Rimegepant
rimegepant ODT 75mg daily
Interventions
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Rimegepant
rimegepant ODT 75mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Advanced Investigative Medicine, Inc.
Hawthorne, California, United States
Velocity Clinical Research - North Hollywood
North Hollywood, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Phoenix Medical Research, LLC
Miami, Florida, United States
The Headache Clinic
Alexandria, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
CVS HealthHub - East Brunswick
East Brunswick, New Jersey, United States
CVS HealthHub - Lawrenceville
Lawrenceville, New Jersey, United States
CVS HealthHUB - Runnemede
Runnemede, New Jersey, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
OK Clinical Research, LLC
Edmond, Oklahoma, United States
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4951011
Identifier Type: OTHER
Identifier Source: secondary_id
BHV3000-405
Identifier Type: -
Identifier Source: org_study_id
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