AzTrials
AzTrials

MigrainePhase 2/3NCT03872453

Acute Treatment Trial in Adult Subjects With Migraines

A Phase 2/3 study testing Zavegepant and Intranasal Aptar Pharma Unit Dose System in people with Migraine, run by Pfizer at 82 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 the study is to evaluate the safety and efficacy of three different intranasal dose levels of zavegepant (BHV-3500), relative to placebo, in the acute treatment of moderate to severe migraine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
Zavegepant and Intranasal Aptar Pharma Unit Dose System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,154 participants
Where
82 sitesUnited States
Study dates
25 Mar 2019to 11 Nov 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

  • 1. Participants have 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, including the following:
  • Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
  • Migraine attacks, on average, lasting about 4-72 hours if untreated.
  • Not more than 8 attacks of moderate to severe intensity per month within the last 3 months.
  • At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout 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 throughout the Screening Period.
  • Participants 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 Screening Visit and the dose is not expected to change during the course of the study.
  • Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Who cannot join

  • Participant with a history of basilar migraine or hemiplegic migraine.
  • Participant with a history of human immunodeficiency virus (HIV) disease.
  • Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Participants with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
  • Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled).
  • Participant has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (for example, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
  • Participant has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.), or has disease that causes malabsorption.
Show all 10Show fewer
  • The participant has a history of current or evidence of any significant and/ or unstable medical conditions (for example, 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 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 subjects who have met Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM-V) criteria for any significant substance use disorder within the past 12 months from the date of the Screening Visit.
  • History of nasal surgery in the 6 months preceding the Screening Visit.
  • Participation in any other investigational clinical trial while participating in this clinical trial.

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

United States82 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Northwest Clinical Research

    Bellevue, Washington, 98007

  • MedPharmics, LLC

    Biloxi, Mississippi, 39531

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Crescent City Headache and Neurology Center, LLC

    Chalmette, Louisiana, 70043

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina, 28209

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Hometown Urgent Care and Research

    Cincinnati, Ohio, 45215

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Hometown Urgent Care and Research

    Columbus, Ohio, 43214

  • CT Clinical Research

    Cromwell, Connecticut, 06416

  • Meridian Clinical Research

    Dakota Dunes, South Dakota, 57049

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75231

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45424

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Denver Neurological Research, LLC

    Denver, Colorado, 80210

  • Pharmacology Research Institute

    Encino, California, 91316

  • Ventavia Research Group

    Fort Worth, Texas, 76104

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

  • PharmQuest

    Greensboro, North Carolina, 27408

  • MD Clinical

    Hallandale, Florida, 33009

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Center for Pharmaceutical Research, LLC

    Kansas City, Missouri, 64114

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53144

  • Alliance for Multispecialty Research/New Orleans Center for Clinical Research/Volunteer Research

    Knoxville, Tennessee, 37920

  • eStudySite

    La Mesa, California, 91942

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 32055

  • Red Star Research, LLC

    Lake Jackson, Texas, 77566

  • Synergy San Diego

    Lemon Grove, California, 91945

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Collaborative Neuroscience Network, LLC

    Long Beach, California, 90806

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Advanced Pharmaceutical Development Clinical Research

    Magnolia, Texas, 77355

  • Community Clinical Research Network

    Marlborough, Massachusetts, 01752

  • Clinical Neuroscience Solutions DBA CNS Healthcare

    Memphis, Tennessee, 38119

  • AGA Clinical Trials

    Miami, Florida, 33012

  • Qps Mra, Llc

    Miami, Florida, 33143

  • 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

  • DelRicht Research

    New Orleans, Louisiana, 70124

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Regeneris Medical

    North Attleboro, Massachusetts, 02169

  • Meritas Health Neurology

    North Kansas City, Missouri, 64116

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73134

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Ormond Medical Arts Pharmaceutical Research Center

    Ormond Beach, Florida, 32174

  • National Research Institute

    Panorama City, California, 91402

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Clinical Research Institute, Inc.

    Plymouth, Minnesota, 55441

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • Phoenix Medical Research

    Prairie Village, Kansas, 66208

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27609

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)

    Salem, Oregon, 97301

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Victorium Clinical Research

    San Antonio, Texas, 78230

  • Optimus Medical Group

    San Francisco, California, 94102

  • Neurological Research Institute

    Santa Monica, California, 90404

  • Meridian Clinical Research

    Savannah, Georgia, 31405

  • QPS Bio-Kinetic Clinical Applications, LLC

    Springfield, Missouri, 65802

  • Clinvest Research LLC

    Springfield, Missouri, 65810

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Ki Health Partners, LLC, dba New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Meridien Research

    Tampa, Florida, 33634

  • Montefiore Medical Center: Headache Center

    The Bronx, New York, 10461

  • Dynamed Clinical Research

    Tomball, Texas, 77375

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • MedVadis Research Corporation

    Watertown, Massachusetts, 02472

  • Family Medicine Specialists/CIS

    Wauconda, Illinois, 60084

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Upstate Clinical Research Associates, LLC

    Williamsville, New York, 14221

  • Wilmington Health, PLLC

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: Phase II/III: Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine

The purpose of the study is to evaluate the safety and efficacy of three different intranasal dose levels of zavegepant (BHV-3500), relative to placebo, in the acute treatment of moderate to severe migraine.

Conditions
Migraine
Being tested
Zavegepant, Zavegepant matching placebo, Intranasal Aptar Pharma Unit Dose System
Keywords
Acute Migraine, phonophobia, photophobia, nausea
Medical subject headings
Migraine Disorders, Hyperacusis, Photophobia, Nausea

What participants receive

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

  • ZavegepantDrug

    Also called BHV3500

    A single dose of zavegepant

  • Zavegepant matching placeboDrug

    A single dose of placebo matched to zavegepant

  • Intranasal Aptar Pharma Unit Dose SystemDevice

    A single-dose intranasal device

Study groups in NCT03872453
Study groupRoleWhat they receive
Zavegepant 5 mgExperimentalParticipants administered a single intranasal dose of zavegepant 5 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar Unidose System (UDS) liquid spray device.
Receives: Drug: Zavegepant; Device: Intranasal Aptar Pharma Unit Dose System
Zavegepant 10 mgExperimentalParticipants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device.
Receives: Drug: Zavegepant; Device: Intranasal Aptar Pharma Unit Dose System
Zavegepant 20 mgExperimentalParticipants administered a single intranasal dose of zavegepant 20 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device.
Receives: Drug: Zavegepant; Device: Intranasal Aptar Pharma Unit Dose System
PlaceboPlacebo comparatorParticipants administered a single intranasal dose of zavegepant-matching placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device.
Receives: Drug: Zavegepant matching placebo; Device: Intranasal Aptar Pharma Unit Dose System

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 clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.

    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 eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack onset that was absent post-dose.

    Measured: 2 hours post-dose

Secondary outcomes (15)

  1. 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 eCOA handheld device. Pain relief was defined as pain level of none or mild.

    Measured: 2 hours post-dose

  2. Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose

    Functional disbaility level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.

    Measured: 2 hours post-dose

  3. 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 eCOA handheld device) 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 (for example, metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the site on a case report form.

    Measured: Through 24 hours post-dose

  4. 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 eCOA handheld device. Freedom from photophobia was defined as photophobia absent post-dose in the subset of participants with photophobia present at on-study migraine attack onset.

    Measured: 2 hours post-dose

  5. 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 eCOA handheld device. Freedom from phonophobia was defined as phonophobia absent post-dose in the subset of participants with phonophobia present at on-study migraine attack onset.

    Measured: 2 hours post-dose

  6. Percentage of Participants With Pain Relief at 60 Minutes Post-dose

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

    Measured: 60 minutes post-dose

  7. Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose

    Functional disbaility level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.

    Measured: 60 minutes post-dose

  8. Percentage of Participants With Pain Relief at 30 Minutes Post-dose

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

    Measured: 30 minutes post-dose

  9. Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose

    Functional disbaility level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.

    Measured: 30 minutes post-dose

  10. 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 eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose.

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

  11. 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 eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose.

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

  12. 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 eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose.

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

  13. 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 eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose.

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

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

    Nausea status was measured as absent or present in the eCOA handheld device. Freedom from nausea was defined as nausea absent post-odse in the subset of participants with nausea present at on-study migraine attack onset.

    Measured: 2 hours post-dose

  15. 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 eCOA handheld device. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose in the subset of participants with pain level of none at 2 hours post-dose.

    Measured: From 2 hours up to 48 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 posted13 Mar 2019
  2. Study start25 Mar 2019
  3. Primary completion31 Oct 2019
  4. Study completion11 Nov 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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03872453
Sponsor's protocol ID
BHV3500-201
Status last verified
Sep 2023
First submitted
6 Mar 2019
Last updated
25 Sep 2023
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Zavegepant and Intranasal Aptar Pharma Unit Dose System in people with Migraine, run by Pfizer at 82 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 8 inclusion and 10 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 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 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 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 13 Oct 2022). 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 NCT03872453.

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 25 Sep 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