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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Photophobia; Episodic Migraine; Phonophobia
• Intervention / Treatment: Drug: Rimegepant

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.

• Study Type: Interventional
• Enrollment (Actual): 441
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies, LLC
  • California
    • Hawthorne, California, United States, 90250
      • Advanced Investigative Medicine, Inc.
    • North Hollywood, California, United States, 91606
      • Velocity Clinical Research - North Hollywood
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Miami, Florida, United States, 33165
      • Phoenix Medical Research, LLC
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • The Headache Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain & Neurological Institute
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • CVS HealthHub - East Brunswick
    • Lawrenceville, New Jersey, United States, 08648
      • CVS HealthHub - Lawrenceville
    • Runnemede, New Jersey, United States, 08078
      • CVS HealthHUB - Runnemede
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Philadelphia, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-Clinsearch, LLC
  • Texas
    • San Antonio, Texas, United States, 78230
      • VIP Trials
    • San Antonio, Texas, United States, 78230
      • VIP Trails
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Tidewater Integrated Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rimegepant; rimegepant 75 mg ODT daily	Drug: Rimegepant; rimegepant ODT 75mg daily; Other Names: BHV-3000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): July 2, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Headache Disorders, Primary; Headache Disorders; Otorhinolaryngologic Diseases; Vision Disorders; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Photophobia; Hyperacusis; rimegepant sulfate
• Other Study ID Numbers: BHV3000-405; C4951011 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No