Safety and Efficacy in Adult Subjects With Acute Migraines

February 14, 2023 updated by: Pfizer

BHV3000-302 : 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1499

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Thunderbird Internal Medicine / Radiant Research, Inc.
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Woodland Research Northwest, LLC
    • California
      • 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
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group, 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
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Tampa, Florida, United States, 33634
        • Meridien Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Radiant Research, Inc.
      • 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
      • Park City, Kansas, United States, 67207
        • 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
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • NECCR Primacare Research, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience, Inc.
    • New York
      • Jamaica, New York, United States, 11432
        • Radiant Research, Inc.
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Raleigh, North Carolina, United States, 27609
        • PMG Research of Raleigh, Inc.
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • 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
      • Scranton, Pennsylvania, United States, 18503
        • Fieve Clinical Research, Inc.
    • South Carolina
      • Anderson, South Carolina, United States, 85282
        • Radiant Research, Inc.
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research
      • Fort Worth, Texas, United States, 76104
        • Ventavia Research Group
      • Lake Jackson, Texas, United States, 77566
        • Red Star Research
      • Lampasas, Texas, United States, 76550
        • FMC Science
      • Magnolia, Texas, United States, 77355
        • PCP for Life
      • Mesquite, Texas, United States, 75149
        • Research Across America
      • Plano, Texas, United States, 75093
        • Doctors of Internal Medicine, LTD / Radiant Research, Inc.
      • Tomball, Texas, United States, 77373
        • DM Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. 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
  2. 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
  3. 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.
  4. Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

  1. Patient history of HIV disease
  2. 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.
  3. 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)
  4. 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
  5. Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption.
  6. 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, hepatitisB 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 ofthe trial
  7. 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 thepast 12 months from the date of the screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rimegepant 75 mg
Participants 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.
Drug: Rimegepant
75 mg tablet QD
Other Names:
  • BHV-3000
Placebo Comparator: Placebo
Participants 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.
Drug: Placebo
Placebo tablet to match rimegepant dose QD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
Time Frame: 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.
2 Hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
Time Frame: 2 Hours
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.
2 Hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
Time Frame: 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.
2 hours post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
Time Frame: 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.
2 hours post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-dose
Time Frame: 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.
2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
Time Frame: 2 hours post-dose
Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.
2 hours post-dose
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
Time Frame: 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.
24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
Time Frame: From 2 hours up 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.
From 2 hours up to 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
Time Frame: From 2 hours up 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.
From 2 hours up to 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
Time Frame: From 2 hours up 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.
From 2 hours up to 48 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
Time Frame: From 2 hours up 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.
From 2 hours up to 48 hours post-dose
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
Time Frame: From 2 hours up 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.
From 2 hours up to 48 hours post-dose
Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose
Time Frame: 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.
2 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BHV3000-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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