Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention
2 other identifiers
interventional
441
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2022
Typical duration for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2024
CompletedResults Posted
Study results publicly available
September 3, 2025
CompletedSeptember 3, 2025
July 1, 2025
2.3 years
January 12, 2022
July 2, 2025
August 13, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in \>=5% participants are reported in this OM.
From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Number of Participants With On-Treatment Serious Adverse Events (SAEs)
An SAE was any event that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; was persistent or caused significant disability/incapacity or congenital anomaly/birth defect in the offspring of a participant who received Rimegepant, or other important medical events. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment.
From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Number of Participants With AEs Leading to Study Drug Discontinuation
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. Number of participants with AEs leading to study drug discontinuations are reported in this outcome measure.
From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
The following laboratory parameters were assessed: eosinophils, hemoglobin low and high, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium low and high, cholesterol, creatine kinase, creatinine, glomerular filtration rate estimated, glucose low and high, lactate dehydrogenase, low-density lipoprotein (LDL) cholesterol, LDL cholesterol fasting and not fasting, potassium low and high, sodium low and high, triglycerides, triglycerides fasting and not fasting, uric acid, urine glucose and urine protein. Laboratory abnormalities were graded according to NCI CTCAE v5.0; where grade 3=severe and grade 4=life-threatening except for glucose, LDL cholesterol, and urinalysis where DAIDS v2.1 was used. (grade 3= severe and grade 4= life-threatening).
From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urine nitrogen, calcium low and high, cholesterol, creatine, glucose low and high, potassium low and high, protein, sodium low and high, urine glucose and urine protein. Laboratory abnormality events were graded according to FDA toxicity grading scale (grade 3= severe and grade 4= life-threatening).
From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Study Arms (1)
Rimegepant
EXPERIMENTALrimegepant 75 mg ODT daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (19)
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018, United States
Advanced Investigative Medicine, Inc.
Hawthorne, California, 90250, United States
Velocity Clinical Research - North Hollywood
North Hollywood, California, 91606, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Phoenix Medical Research, LLC
Miami, Florida, 33165, United States
The Headache Clinic
Alexandria, Louisiana, 71301, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
CVS HealthHub - East Brunswick
East Brunswick, New Jersey, 08816, United States
CVS HealthHub - Lawrenceville
Lawrenceville, New Jersey, 08648, United States
CVS HealthHUB - Runnemede
Runnemede, New Jersey, 08078, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
Velocity Clinical Research
Cincinnati, Ohio, 45242, United States
OK Clinical Research, LLC
Edmond, Oklahoma, 73034, United States
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
VIP Trails
San Antonio, Texas, 78230, United States
VIP Trials
San Antonio, Texas, 78230, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Related Publications (1)
Antinew J, Fountaine RJ, Loprinzo V, Straghan E, Dubrovin S, DeBesi P, Vatakis N, Fullerton T. A phase 4, 24-week, open-label study to evaluate the safety and tolerability of once-daily dosing of 75 mg rimegepant for episodic migraine prevention. J Headache Pain. 2025 Dec 9. doi: 10.1186/s10194-025-02225-7. Online ahead of print.
PMID: 41366286DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2022
First Posted
January 26, 2022
Study Start
March 15, 2022
Primary Completion
July 2, 2024
Study Completion
July 2, 2024
Last Updated
September 3, 2025
Results First Posted
September 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
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.