Open Label Safety Study in Acute Treatment of Migraine

A Multicenter, Open Label Long-Term Safety Study of BHV-3000 in the Acute Treatment of Migraine

The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).

Study Overview

• Status: Completed
• Conditions: Migraine, With or Without Aura
• Intervention / Treatment: Drug: Rimegepant

• Study Type: Interventional
• Enrollment (Actual): 3019
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, Inc
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Thunderbird Internal Medicine / Radiant Research, Inc
    • Tempe, Arizona, United States, 85283
      • Clinical Research Consortium Arizona
    • Tempe, Arizona, United States, 85202
      • Neurological Physicians of Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group, LLC
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest, LLC
  • California
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • La Mesa, California, United States, 91942
      • eStudySite
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • Oakland, California, United States, 94607
      • Pacific Research Partners LLC
    • Panorama City, California, United States, 91402
      • National Research Institute
    • San Francisco, California, United States, 94102
      • Optimus Medical Group
    • Santa Monica, California, United States, 90404
      • California Medical Clinic for Headache
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc.
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc
  • Colorado
    • Denver, Colorado, United States, 80209
      • Clinical Trials of the Rockies
  • Florida
    • Hialeah, Florida, United States, 33012
      • AGA Clinical Trials
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Lake City, Florida, United States, 32055
      • Multi-Specialty Research Associates, Inc
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc
    • Ormond Beach, Florida, United States, 32174
      • Ormond Medical Arts Pharmaceutical Research
    • Tampa, Florida, United States, 33634
      • Meridien Research
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Radiant Research, Inc.
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research
    • Savannah, Georgia, United States, 31406
      • Savannah Neurology Specialists
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Christie Clinic, LLC
  • Iowa
    • Ames, Iowa, United States, 50010
      • PMG Research of McFrland Clinic
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Heartland Research Associates, LLC
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
    • Metairie, Louisiana, United States, 70006
      • Benchmark Research
    • New Orleans, Louisiana, United States, 70119
      • New Orleans Center for Clinical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials, Inc.
    • Fall River, Massachusetts, United States, 02721
      • NECCR PrimaCare Research, LLC
    • Marlborough, Massachusetts, United States, 01752
      • Milford Emergency Associates, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain and Neurological Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc.
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Insitute
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research -Norfolk
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium- Las Vegas
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience, Inc.
  • New York
    • Binghamton, New York, United States, 13901
      • United Medical Associates
    • Bronx, New York, United States, 10461
      • Montefiore Heachache Center
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
    • Endwell, New York, United States, 13760
      • Regional Clinical Research, Inc.
    • Jamaica, New York, United States, 11432
      • Radiant Research, Inc.
    • Manlius, New York, United States, 13104
      • Central New York Clinical Research
    • New York, New York, United States, 10168
      • Fieve Clinical Research
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte, LLC
    • Greensboro, North Carolina, United States, 27408
      • Pharmquest, LLC
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45236
      • Radiant Research, Inc.
    • Columbus, Ohio, United States, 43212
      • Radiant Research, Inc.
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • Dayton, Ohio, United States, 45459
      • Neurology Diagnostics, Inc.
    • Dublin, Ohio, United States, 43016
      • Aventiv Research, Inc.
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network (Oregon), Inc.
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations, Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Of Philadelphia, Llc
    • Scranton, Pennsylvania, United States, 18503
      • Fieve Clinical Research
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Meridian Clinical Research
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • PMG Research of Bristol, LLC
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology, LP
    • Austin, Texas, United States, 78745
      • Tekton Research- Austin
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Neurology, LP
    • Fort Worth, Texas, United States, 76104
      • Ventavia Research Group, LLC
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development
    • Lake Jackson, Texas, United States, 77566
      • Red Star Research, LLC
    • Lampasas, Texas, United States, 76550
      • FMC Science
    • Magnolia, Texas, United States, 77355
      • PCP for Life
    • Mesquite, Texas, United States, 75149
      • Research Across America - Mesquite
    • Plano, Texas, United States, 75093
      • Doctors of Internal Medicine, LTD / Radiant Research Inc.
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • J.Lewis Research Inc / Foothill Family Clinic South
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Tidewater Integrated Medical Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Seattle, Washington, United States, 98105
      • Seattle Women's:Health, Research & Gynecology

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

• Subjects with 2-8 moderate to severe migraines/month
• Age of onset of migraines prior to 50 years of age
• Migraine attacks, on average, lasting 4-72 hours if untreated
• Ability to distinguish migraine attacks from tension/cluster headaches
• Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria

Key Exclusion Criteria:

• History of basilar migraine or hemiplegic migraine
• History of HIV disease
• History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia.
• Uncontrolled hypertension or uncontrolled diabetes (however, patients can be included who have stable hypertension and /or diabetes for 3 months prior to screening
• History of gastric or small intestinal surgery or has a disease that causes malabsorption
• BMI ≥ 30
• HbA1c ≥ 6.5%

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	Drug: Rimegepant; 75 mg oral tablet; Other Names: BHV-3000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period	Clinically significant laboratory abnormalities were defined as Grade 3 to 4 on-treatment laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for Glucose, LDL-Cholesterol, Uric Acid, and Urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the on-treatment period to be included for a given parameter.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin > 2 x ULN During the Treatment Period	Elevations of on-treatment AST or ALT > 3 x ULN concurrent with total bilirubin > 2 x ULN were defined as elevations on the same collection date.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation patient administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Hepatic AEs were defined as all on-treatment PTs under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those PTs in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Johnston K, Harris L, Powell L, Popoff E, Coric V, L'Italien G, Schreiber CP. Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant - post hoc results from an open label safety study (BHV3000-201). J Headache Pain. 2022 Jan 17;23(1):10. doi: 10.1186/s10194-021-01378-5.
• Johnston KM, L'Italien G, Popoff E, Powell L, Croop R, Thiry A, Harris L, Coric V, Lipton RB. Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant. Adv Ther. 2021 Oct;38(10):5209-5220. doi: 10.1007/s12325-021-01897-2. Epub 2021 Aug 29.
• Mullin K, Kudrow D, Croop R, Lovegren M, Conway CM, Coric V, Lipton RB. Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology. 2020 May 19;94(20):e2121-e2125. doi: 10.1212/WNL.0000000000008944. Epub 2020 Jan 13. Erratum In: Neurology. 2020 May 19;94(20):900.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): July 15, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: BHV3000-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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