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

Sponsor
Biohaven Pharmaceutical Holding Company Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05207865
Collaborator
(none)
125
Enrollment
19
Locations
1
Arm
18.2
Anticipated Duration (Months)
6.6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 4, Open-Label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention
Actual Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Sep 20, 2023
Anticipated Study Completion Date :
Sep 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rimegepant

rimegepant 75 mg ODT daily

Drug: Rimegepant
rimegepant ODT 75mg daily
Other Names:
  • BHV-3000

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • Male and female 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 60 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Elite Clinical Studies, LLC Phoenix Arizona United States 85018
    2 AIM Hawthorne California United States 90250
    3 Velocity Clinical Research - North Hollywood North Hollywood California United States 91606
    4 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    5 Phoenix Medical Research Miami Florida United States 33165
    6 The Headache Clinic Alexandria Louisiana United States 71301
    7 Boston Clinical Trials Boston Massachusetts United States 02131
    8 MHNI Ann Arbor Michigan United States 48104
    9 CVS HealthHub-East Brunswick East Brunswick New Jersey United States 08816
    10 CVS HealthHub-Lawrenceville Lawrenceville New Jersey United States 08816
    11 CVS HealthHub-Runnemede Runnemede New Jersey United States 08078
    12 SPRI Clinical Trials, LLC Brooklyn New York United States 11235
    13 Velocity Clinical Research Cincinnati Cincinnati Ohio United States 45242
    14 Aventiv Research Dublin Ohio United States 43016
    15 OK Clinical Research, LLC Edmond Oklahoma United States 73034
    16 Clinical Research Philadelphia Philadelphia Pennsylvania United States 19114
    17 WR-ClinSearch, LLC. Chattanooga Tennessee United States 37421
    18 VIP Trials San Antonio Texas United States 78230
    19 Tidewater Integrated Medical Research Virginia Beach Virginia United States 23454

    Sponsors and Collaborators

    • Biohaven Pharmaceutical Holding Company Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biohaven Pharmaceutical Holding Company Ltd.
    ClinicalTrials.gov Identifier:
    NCT05207865
    Other Study ID Numbers:
    • BHV3000-405
    First Posted:
    Jan 26, 2022
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyperacusis
    Migraine Disorders
    Photophobia

    Study Results

    No Results Posted as of Jun 6, 2022