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
1 other identifier
interventional
3,019
1 country
98
Brief Summary
The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2017
98 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
August 23, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
August 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2019
CompletedResults Posted
Study results publicly available
July 2, 2020
CompletedFebruary 16, 2023
February 1, 2023
1.9 years
August 23, 2017
June 16, 2020
February 14, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
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
PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Study Arms (1)
Rimegepant
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (98)
Central Research Associates, Inc
Birmingham, Alabama, 35205, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Thunderbird Internal Medicine / Radiant Research, Inc
Glendale, Arizona, 85306, United States
Neurological Physicians of Arizona
Tempe, Arizona, 85202, United States
Clinical Research Consortium Arizona
Tempe, Arizona, 85283, United States
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758, United States
Pharmacology Research Institute
Encino, California, 91316, United States
eStudySite
La Mesa, California, 91942, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Pacific Research Partners LLC
Oakland, California, 94607, United States
National Research Institute
Panorama City, California, 91402, United States
Optimus Medical Group
San Francisco, California, 94102, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Diablo Clinical Research, Inc
Walnut Creek, California, 94598, United States
Clinical Trials of the Rockies
Denver, Colorado, 80209, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Multi-Specialty Research Associates, Inc
Lake City, Florida, 32055, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Ormond Medical Arts Pharmaceutical Research
Ormond Beach, Florida, 32174, United States
Meridien Research
Tampa, Florida, 33634, United States
Radiant Research, Inc.
Atlanta, Georgia, 30328, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Savannah Neurology Specialists
Savannah, Georgia, 31406, United States
Christie Clinic, LLC
Champaign, Illinois, 61820, United States
PMG Research of McFrland Clinic
Ames, Iowa, 50010, United States
Heartland Research Associates, LLC
Augusta, Kansas, 67010, United States
Heartland Research Associates, LLC
Newton, Kansas, 67114, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67205, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Benchmark Research
Metairie, Louisiana, 70006, United States
MedPharmics, LLC
Metairie, Louisiana, 70006, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Boston Clinical Trials, Inc.
Boston, Massachusetts, 02131, United States
NECCR Primacare Research, LLC
Fall River, Massachusetts, 02721, United States
Milford Emergency Associates, Inc.
Marlborough, Massachusetts, 01752, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Clinical Research Insitute
Plymouth, Minnesota, 55441, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Meridian Clinical Research -Norfolk
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Clinical Research Consortium- Las Vegas
Las Vegas, Nevada, 89119, United States
Hassman Research Institute, LLC
Berlin, New Jersey, 08009, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
United Medical Associates
Binghamton, New York, 13901, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Radiant Research, Inc.
Jamaica, New York, 11432, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
Fieve Clinical Research
New York, New York, 10168, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
Montefiore Heachache Center
The Bronx, New York, 10461, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
PharmQuest, LLC
Greensboro, North Carolina, 27408, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45227, United States
Radiant Research, Inc.
Cincinnati, Ohio, 45236, United States
Radiant Research, Inc.
Columbus, Ohio, 43212, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459, United States
Aventiv Research, Inc.
Dublin, Ohio, 43016, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210, United States
Oregon Center for Clinical Investigations, Inc
Salem, Oregon, 97301, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
Fieve Clinical Research
Scranton, Pennsylvania, 18503, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
FutureSearch Trials of Neurology, LP
Austin, Texas, 78731, United States
Tekton Research- Austin
Austin, Texas, 78745, United States
FutureSearch Trials of Neurology, LP
Dallas, Texas, 75231, United States
Ventavia Research Group, LLC
Fort Worth, Texas, 76104, United States
Texas Center for Drug Development
Houston, Texas, 77081, United States
Red Star Research, LLC
Lake Jackson, Texas, 77566, United States
FMC Science
Lampasas, Texas, 76550, United States
PCP for Life
Magnolia, Texas, 77355, United States
Research Across America - Mesquite
Mesquite, Texas, 75149, United States
Doctors of Internal Medicine, LTD / Radiant Research Inc.
Plano, Texas, 75093, United States
DM Clinical Research
Tomball, Texas, 77375, United States
J.Lewis Research Inc / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Seattle Women's:Health, Research & Gynecology
Seattle, Washington, 98105, United States
Related Publications (8)
Ailani J, Pavlovic J, Pixton GC, Fullerton T. Rimegepant safety and patient-reported outcomes among triptan-naive, triptan-using, and triptan-failure participants: Subgroup analysis of an open-label, multicenter study. Cephalalgia. 2025 Jul;45(7):3331024251343309. doi: 10.1177/03331024251343309. Epub 2025 Jul 9.
PMID: 40629887DERIVEDKudrow D, Hutchinson S, Pixton GC, Fullerton T. Safety of Rimegepant in Adults with Migraine and Anxiety, Depression, or Using Antidepressants: Analysis of a Multicenter, Long-Term, Open-Label Study. Pain Ther. 2025 Feb;14(1):237-255. doi: 10.1007/s40122-024-00675-6. Epub 2024 Nov 9.
PMID: 39520634DERIVEDTrue D, Mullin K, Croop R. Safety of Rimegepant in Adults with Migraine and Cardiovascular Risk Factors: Analysis of a Multicenter, Long-Term, Open-Label Study. Pain Ther. 2024 Oct;13(5):1203-1218. doi: 10.1007/s40122-024-00626-1. Epub 2024 Jul 10.
PMID: 38985436DERIVEDFullerton T, Pixton G. Long-Term Use of Rimegepant 75 mg for the Acute Treatment of Migraine is Associated with a Reduction in the Utilization of Select Analgesics and Antiemetics. J Pain Res. 2024 May 15;17:1751-1760. doi: 10.2147/JPR.S456006. eCollection 2024.
PMID: 38764606DERIVEDCroop R, Berman G, Kudrow D, Mullin K, Thiry A, Lovegren M, L'Italien G, Lipton RB. A multicenter, open-label long-term safety study of rimegepant for the acute treatment of migraine. Cephalalgia. 2024 Apr;44(4):3331024241232944. doi: 10.1177/03331024241232944.
PMID: 38659334DERIVEDJohnston 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.
PMID: 35038983DERIVEDJohnston 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.
PMID: 34455556DERIVEDMullin 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.
PMID: 31932515DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Biohaven Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2017
First Posted
August 30, 2017
Study Start
August 30, 2017
Primary Completion
July 15, 2019
Study Completion
July 15, 2019
Last Updated
February 16, 2023
Results First Posted
July 2, 2020
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share