AzTrials
AzTrials

Migraine, With or Without AuraPhase 3NCT03235479

Safety and Efficacy Study in Adult Subjects With Acute Migraines

A Phase 3 study testing Rimegepant in people with Migraine, With or Without Aura, run by Pfizer at 50 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 compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines 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?
Yes, some participants may receive a placebo
How many people
1,485 participants
Where
50 sitesUnited States
Study dates
18 Jul 2017to 26 Jan 2018
Phase
Phase 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

  • Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version[1] including the following:
  • Not more than 8 attacks of moderate or severe intensity per month within last 3 months
  • Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
  • Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
  • Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
  • Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Who cannot join

  • Patient history of HIV disease
  • Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
  • Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
  • Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
  • Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal-absorption
  • The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known 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 trial
  • History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

  • FutureSearch Trials of Neurology, LP

    Austin, Texas, 78731

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Hassman Research Institute, LLC

    Berlin, New Jersey, 08009

  • Central Research Associates, Inc

    Birmingham, Alabama, 35205

  • Boston Clinical Trials, Inc

    Boston, Massachusetts, 02131

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45227

  • Meridian Clinical Research

    Dakota Dunes, South Dakota, 57409

  • FutureSearch Trials of Neurology, LP

    Dallas, Texas, 75231

  • Pharmacology Research Institute

    Encino, California, 91316

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Neurological Physicians of Arizona/Radiant Research Inc

    Gilbert, Arizona, 85282

  • PharmQuest, LLC

    Greensboro, North Carolina, 27408

  • Qps Mra, Llc

    Hollywood, Florida, 33024

  • Texas Center for Drug Development

    Houston, Texas, 77081

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Multi-Specialty Research Associates, Inc

    Lake City, Florida, 32055

  • Clinical Research Consortium- Las Vegas

    Las Vegas, Nevada, 89119

  • Woodland International Research Group, LLC

    Little Rock, Arkansas, 72211

  • Central New York Clinical Research

    Manlius, New York, 13104

  • Milford Emergency Associates, Inc.

    Marlborough, Massachusetts, 01752

  • Qps Mra, Llc

    Miami, Florida, 33143

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • Clinical Research Institute, Inc

    Minneapolis, Minnesota, 55402

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Fieve Clinical Research

    New York, New York, 10168

  • Meridian Clinical Research -Norfolk

    Norfolk, Nebraska, 68701

  • Clinical Research Associates of Tidewater, Inc.

    Norfolk, Virginia, 23507

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Ormond Medical Arts Pharmaceutical Research

    Ormond Beach, Florida, 32174

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114-1029

  • Oregon Center for Clinical Investigations, Inc

    Portland, Oregon, 97214

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609

  • 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

  • Seattle Women's:Health, Research & Gynecology

    Seattle, Washington, 98105

  • J.Lewis Research Inc. / Jordan River Family Med

    South Jordan, Utah, 84095

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Clinical Research Consortium Arizona

    Tempe, Arizona, 85283

  • Radiant Research, Inc.

    Tucson, Arizona, 85712

  • 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

Other trials in United States

About this study

Official title: BHV3000-301: Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines

Being tested
Rimegepant, Placebo
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 tablet QD

  • PlaceboDrug

    Placebo tablet to match rimegepant dose QD

Study groups in NCT03235479
Study groupRoleWhat they receive
Rimegepant 75 mgExperimentalParticipants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Receives: Drug: Rimegepant
PlaceboPlacebo comparatorParticipants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants With Freedom From Pain at 2 Hours Post-dose

    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.

    Measured: 2 hours post-dose

  2. Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose

    MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.

    Measured: 2 hours post-dose

Secondary outcomes (11)

  1. Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose

    Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.

    Measured: 2 hours post-dose

  2. Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose

    Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.

    Measured: 2 hours post-dose

  3. Percentage of Participants With Pain Relief at 2 Hours Post-dose

    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.

    Measured: 2 hours post-dose

  4. Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose

    Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.

    Measured: 2 hours post-dose

  5. Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose

    Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eDiary) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary.

    Measured: 24 hours post-dose

  6. Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose

    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.

    Measured: From 2 hours up to 24 hours post-dose

  7. Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose

    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.

    Measured: From 2 hours up to 24 hours post-dose

  8. Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose

    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.

    Measured: From 2 hours up to 48 hours post-dose

  9. Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose

    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.

    Measured: From 2 hours up to 48 hours post-dose

  10. Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose

    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours for the participants who were pain-free at 2 hours post-dose.

    Measured: From 2 hours up to 48 hours post-dose

  11. Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose

    Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.

    Measured: 2 hours post-dose

Timeline

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

  1. First posted1 Aug 2017
  2. Study start18 Jul 2017
  3. Primary completion21 Jan 2018
  4. Study completion26 Jan 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03235479
Sponsor's protocol ID
BHV-3000-301
Status last verified
Feb 2023
First submitted
14 Jul 2017
Last updated
16 Feb 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Vieira JR, Fajardo M, Abbott C, Li J, Sellix MT. Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Adults of Hispanic or Latino Ethnicity: Post Hoc Analysis of Three Randomized, Placebo-Controlled Trials. Neurol Ther. 2026 Oct 6. doi: 10.1007/s40120-026-01025-8. Online ahead of print.

    PubMed 42839212

  • Charleston L 4th, Armand CE, Monteith TS, O'Brien HL, Abbott CC, Pixton GC, Fullerton T. Efficacy and safety of rimegepant for the acute treatment of migraine in Black or African American adults: A post hoc pooled subgroup analysis from three randomized, placebo-controlled clinical trials. Headache. 2026 Apr;66(4):874-884. doi: 10.1111/head.70034. Epub 2026 Feb 6.

    PubMed 41652666

  • Lipton RB, Thiry A, Morris BA, Croop R. Efficacy and Safety of Rimegepant 75 mg Oral Tablet, a CGRP Receptor Antagonist, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain Res. 2024 Jul 22;17:2431-2441. doi: 10.2147/JPR.S453806. eCollection 2024.

    PubMed 39070853

  • Lipton RB, Blumenfeld A, Jensen CM, Croop R, Thiry A, L'Italien G, Morris BA, Coric V, Goadsby PJ. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023 Feb;43(2):3331024221141686. doi: 10.1177/03331024221141686.

    PubMed 36739511

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rimegepant in people with Migraine, With or Without Aura, run by Pfizer at 50 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 6 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 50 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 23 Dec 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?

Percentage of Participants With Freedom From Pain at 2 Hours Post-dose (time frame: 2 hours post-dose). 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 NCT03235479, which also lists 4 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in