Back to resultsSafety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
Primary Purpose
Migraine, Episodic Migraine, Phonophobia
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rimegepant
Sponsored by
About this trial
This is an interventional treatment trial for 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
- 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
Sites / Locations
- Elite Clinical Studies, LLCRecruiting
- Advanced Investigative Medicine, Inc.Recruiting
- Velocity Clinical Research - North HollywoodRecruiting
- Chase Medical Research, LLCRecruiting
- Phoenix Medical Research, LLCRecruiting
- The Headache ClinicRecruiting
- Boston Clinical TrialsRecruiting
- Michigan Head Pain & Neurological InstituteRecruiting
- CVS HealthHub - East BrunswickRecruiting
- CVS HealthHub - LawrencevilleRecruiting
- CVS HealthHUB - RunnemedeRecruiting
- SPRI Clinical Trials, LLCRecruiting
- Velocity Clinical ResearchRecruiting
- OK Clinical Research, LLCRecruiting
- Clinical Research Philadelphia, LLCRecruiting
- WR-ClinSearch, LLCRecruiting
- VIP TrailsRecruiting
- VIP TrialsRecruiting
- Tidewater Integrated Medical ResearchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rimegepant
Arm Description
rimegepant 75 mg ODT daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05207865
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
October 9, 2024 (Anticipated)
Study Completion Date
February 8, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Episodic Migraine, Phonophobia, Photophobia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
285 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rimegepant
Arm Type
Experimental
Arm Description
rimegepant 75 mg ODT daily
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Other Intervention Name(s)
BHV-3000
Intervention Description
rimegepant ODT 75mg daily
Primary Outcome Measure Information:
Title
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.
Time Frame
Over a 6 month period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Investigative Medicine, Inc.
City
Hawthorne
State/Province
California
ZIP/Postal Code
90250
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - North Hollywood
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Individual Site Status
Recruiting
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
The Headache Clinic
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Recruiting
Facility Name
CVS HealthHub - East Brunswick
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Name
CVS HealthHub - Lawrenceville
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Individual Site Status
Recruiting
Facility Name
CVS HealthHUB - Runnemede
City
Runnemede
State/Province
New Jersey
ZIP/Postal Code
08078
Country
United States
Individual Site Status
Recruiting
Facility Name
SPRI Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
OK Clinical Research, LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Name
WR-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Name
VIP Trails
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Individual Site Status
Recruiting
Facility Name
VIP Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Individual Site Status
Recruiting
Facility Name
Tidewater Integrated Medical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=BHV3000-405
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
We'll reach out to this number within 24 hrs