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Migraine, With or Without AuraPhase 2/3NCT03266588

Open Label Safety Study in Acute Treatment of Migraine

A Phase 2/3 study testing Rimegepant in people with Migraine, With or Without Aura, run by Pfizer at 98 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine, With or Without Aura
What is being tested?
Rimegepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,019 participants
Where
98 sitesUnited States
Study dates
30 Aug 2017to 15 Jul 2019
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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%

Trial locations and contacts

98 sites in 1 country.

98 sites in 1 country

United States98 sites

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • PMG Research of McFrland Clinic

    Ames, Iowa, 50010

  • Radiant Research, Inc.

    Anderson, South Carolina, 29621

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • Radiant Research, Inc.

    Atlanta, Georgia, 30328

  • Heartland Research Associates, LLC

    Augusta, Kansas, 67010

  • FutureSearch Trials of Neurology, LP

    Austin, Texas, 78731

  • Tekton Research- Austin

    Austin, Texas, 78745

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Hassman Research Institute, LLC

    Berlin, New Jersey, 08009

  • United Medical Associates

    Binghamton, New York, 13901

  • Central Research Associates, Inc

    Birmingham, Alabama, 35205

  • Boston Clinical Trials, Inc.

    Boston, Massachusetts, 02131

  • PMG Research of Bristol, LLC

    Bristol, Tennessee, 37620

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

  • Christie Clinic, LLC

    Champaign, Illinois, 61820

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina, 28209

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45227

  • Radiant Research, Inc.

    Cincinnati, Ohio, 45236

  • Radiant Research, Inc.

    Columbus, Ohio, 43212

  • Meridian Clinical Research

    Dakota Dunes, South Dakota, 57049

  • FutureSearch Trials of Neurology, LP

    Dallas, Texas, 75231

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • Clinical Trials of the Rockies

    Denver, Colorado, 80209

  • Aventiv Research, Inc.

    Dublin, Ohio, 43016

  • Pharmacology Research Institute

    Encino, California, 91316

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • NECCR Primacare Research, LLC

    Fall River, Massachusetts, 02721

  • Ventavia Research Group, LLC

    Fort Worth, Texas, 76104

  • Thunderbird Internal Medicine / Radiant Research, Inc

    Glendale, Arizona, 85306

  • PharmQuest, LLC

    Greensboro, North Carolina, 27408

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • Texas Center for Drug Development

    Houston, Texas, 77081

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Radiant Research, Inc.

    Jamaica, New York, 11432

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • eStudySite

    La Mesa, California, 91942

  • Multi-Specialty Research Associates, Inc

    Lake City, Florida, 32055

  • Red Star Research, LLC

    Lake Jackson, Texas, 77566

  • FMC Science

    Lampasas, Texas, 76550

  • Clinical Research Consortium- Las Vegas

    Las Vegas, Nevada, 89119

  • Woodland International Research Group, LLC

    Little Rock, Arkansas, 72211

  • Collaborative Neuroscience Network, LLC

    Long Beach, California, 90806

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • PCP for Life

    Magnolia, Texas, 77355

  • Central New York Clinical Research

    Manlius, New York, 13104

  • Milford Emergency Associates, Inc.

    Marlborough, Massachusetts, 01752

  • Clinical Neuroscience Solutions, Inc

    Memphis, Tennessee, 38119

  • Research Across America - Mesquite

    Mesquite, Texas, 75149

  • Benchmark Research

    Metairie, Louisiana, 70006

  • MedPharmics, LLC

    Metairie, Louisiana, 70006

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Fieve Clinical Research

    New York, New York, 10168

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • Meridian Clinical Research -Norfolk

    Norfolk, Nebraska, 68701

  • Pacific Research Partners LLC

    Oakland, California, 94607

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Ormond Medical Arts Pharmaceutical Research

    Ormond Beach, Florida, 32174

  • National Research Institute

    Panorama City, California, 91402

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Doctors of Internal Medicine, LTD / Radiant Research Inc.

    Plano, Texas, 75093

  • Clinical Research Insitute

    Plymouth, Minnesota, 55441

  • Summit Research Network (Oregon), Inc.

    Portland, Oregon, 97210

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27609

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609

  • Woodland Research Northwest, LLC

    Rogers, Arkansas, 72758

  • Oregon Center for Clinical Investigations, Inc

    Salem, Oregon, 97301

  • J.Lewis Research Inc / Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Optimus Medical Group

    San Francisco, California, 94102

  • California Medical Clinic for Headache

    Santa Monica, California, 90404

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Savannah Neurology Specialists

    Savannah, Georgia, 31406

  • Fieve Clinical Research

    Scranton, Pennsylvania, 18503

  • Seattle Women's:Health, Research & Gynecology

    Seattle, Washington, 98105

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Meridien Research

    Tampa, Florida, 33634

  • Neurological Physicians of Arizona

    Tempe, Arizona, 85202

  • Clinical Research Consortium Arizona

    Tempe, Arizona, 85283

  • Montefiore Heachache Center

    The Bronx, New York, 10461

  • DM Clinical Research

    Tomball, Texas, 77375

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454

  • Diablo Clinical Research, Inc

    Walnut Creek, California, 94598

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: 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).

Being tested
Rimegepant
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RimegepantDrug

    Also called BHV-3000

    75 mg oral tablet

Study groups in NCT03266588
Study groupRoleWhat they receive
RimegepantExperimentalNot described
Receives: Drug: Rimegepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

  2. 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.

    Measured: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks

Secondary outcomes (2)

  1. 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.

    Measured: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

  2. 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.

    Measured: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2017
  2. Study start30 Aug 2017
  3. Primary completion15 Jul 2019
  4. Study completion15 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3,019 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03266588
Sponsor's protocol ID
BHV3000-201
Status last verified
Feb 2023
First submitted
23 Aug 2017
Last updated
16 Feb 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40629887

  • Kudrow 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.

    PubMed 39520634

  • True 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.

    PubMed 38985436

  • Fullerton 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.

    PubMed 38764606

  • Croop 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.

    PubMed 38659334

  • 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.

    PubMed 35038983

  • 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.

    PubMed 34455556

  • 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.

    PubMed 31932515

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rimegepant in people with Migraine, With or Without Aura, run by Pfizer at 98 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period (time frame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03266588, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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