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MigrainePhase 3NCT04571060

Randomized Trial in Adult Participants With Acute Migraines

A Phase 3 study testing Zavegepant in people with Migraine, run by Pfizer at 94 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 test the safety and efficacy of BHV-3500 (zavegepant) versus placebo in the acute treatment of moderate or 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,978 participants
Where
94 sitesUnited States
Study dates
27 Oct 2020to 22 Oct 2021
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

  • Participant 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, 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 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.
Show all 9Show fewer
  • 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.
  • Male and Female participants ≥18 years of age.

Who cannot join

  • Participant with a history of 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 (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 participants can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled).
  • Participants with major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder.
  • History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or participants who have met DSM-V criteria for any significant substance use disorder within the past 12 months.
  • History of nasal surgery in the 6 months.
  • Evidence at screening of significant nasal conditions that may affect the administration or absorption of the nasal product (e.g. severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosal erosion or ulceration, polyposis, nasal trauma)
  • Participation in any other investigational clinical trial while participating in this clinical trial. Participation in a COVID-19 mRNA vaccine study (vaccine must be authorized under FDA emergency use authorization or approval) who are at least 30 days post last dose of the vaccine are permitted to be screened for this study.

Trial locations and contacts

94 sites in 1 country.

94 sites in 1 country

United States94 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Michigan Headache and Neurological Institute

    Ann Arbor, Michigan, 48104

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Donald J. Garcia, Jr, MD, PA

    Austin, Texas, 78737

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Neurology Offices of South Florida

    Boca Raton, Florida, 33428

  • Northwest Clinical Trials Inc.

    Boise, Idaho, 83704

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Crescent City Headache and Neurology Center

    Chalmette, Louisiana, 70043

  • MD First Research

    Chandler, Arizona, 85286

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Hometown Urgent Care & Research/ Wellnow

    Cincinnati, Ohio, 45215

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Axiom Research, LLC

    Colton, California, 92324

  • Hometown Urgent Care and Research

    Columbus, Ohio, 43214

  • CT Clinical Research

    Cromwell, Connecticut, 06416

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45424

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • OK Clinical Research LLC

    Edmond, Oklahoma, 73034

  • Pharmacology Research Institute

    Encino, California, 91316

  • Regional Clinical Research

    Endwell, New York, 13760

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

  • PharmQuest LLC

    Greensboro, North Carolina, 27408

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Clinical Investigation Specialist, Inc.

    Kenosha, Wisconsin, 53144

  • Volunteer Research Group

    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

  • Meridien Research

    Lake Mary, Florida, 32746

  • MD First Research

    Lancaster, South Carolina, 29720

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • 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

  • Clinical Research Institute

    Los Angeles, California, 90404

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Central New York Clinical Research

    Manlius, New York, 13104

  • Community Clinical Research Network

    Marlborough, Massachusetts, 01752

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • AppleMed Research Group, LLC

    Miami, Florida, 33155

  • The Neurology Research Group

    Miami, Florida, 33176

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • Coastal Clinical Research, LLC, An AMR Co.

    Mobile, Alabama, 36608

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • The Orthopedic Foundation

    New Albany, Ohio, 43054

  • DelRicht Research

    New Orleans, Louisiana, 70124

  • Fieve Clinical Research, Inc

    New York, New York, 10017

  • Wr-Pri, Llc

    Newport Beach, California, 92660

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32819

  • Complete Health Research

    Ormond Beach, Florida, 32174

  • Ideal Clinical Research

    Pembroke Pines, Florida, 33026

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania, 15236

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • Summit Research Network

    Portland, Oregon, 97210

  • Collective Medical Research

    Prairie Village, Kansas, 66208

  • PMG of Raleigh, LLC

    Raleigh, North Carolina, 27609

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Alpine Medical Group

    Salt Lake City, Utah, 84107

  • Clinical Trials of Texas, Inc. (CTT)

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington, 98105

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403

  • Boston Neuro Research Center

    South Dartmouth, Massachusetts, 02747

  • J. Lewis Research, Inc. / Jordan River Family Medicine

    South Jordan, Utah, 84095

  • Clin-Med Research & Development, LLC

    South Miami, Florida, 33143

  • 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, 06095

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • JSV Clinical Research Study, Inc.

    Tampa, Florida, 33634

  • Montefiore Medical Center: Headache Center

    The Bronx, New York, 10461

  • DM Clinical Research

    Tomball, Texas, 77375

  • Tucson Neuroscience Research

    Tucson, Arizona, 85710

  • Preferred Primary Care Physicians, Inc.

    Union, Pennsylvania, 15401

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454

  • Medvadis Research Corporation

    Waltham, Massachusetts, 02451

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67205

  • Wilmington Health, PLLC

    Wilmington, North Carolina, 28401

  • Tekton Research, Inc.

    Yukon, Oklahoma, 73099

Other trials in United States

About this study

Official title: Double-Blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal for the Acute Treatment of Migraine

The purpose of this study is to test the safety and efficacy of BHV-3500 (zavegepant) versus placebo in the acute treatment of moderate or severe migraine.

Conditions
Migraine
Being tested
Zavegepant, Placebo
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

    One dose of zavegepant

  • PlaceboDrug

    One dose of matching placebo

Study groups in NCT04571060
Study groupRoleWhat they receive
ZavegepantExperimentalParticipants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar Unidose System (UDS) liquid spray device.
Receives: Drug: Zavegepant
PlaceboPlacebo comparatorParticipants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
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 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 immediately before dosing 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 (17)

  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 disability 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 Sustained Pain Relief From 2 Hours to 24 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 to 24 hours post-dose

  4. Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 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 to 48 hours post-dose

  5. Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 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 to 24 hours post-dose

  6. Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 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 to 48 hours post-dose

  7. 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

  8. 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

  9. 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

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

    Functional disability 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) present at on-study migraine attack onset.

    Measured: 60 minutes post-dose

  11. 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

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

    Functional disability 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

  13. Percentage of Participants With Pain Relief at 15 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: 15 minutes post-dose

  14. Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose

    Functional disability 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: 15 minutes post-dose

  15. 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

  16. 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-dose in the subset of participants with nausea present at on-study migraine attack onset.

    Measured: 2 hours post-dose

  17. 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 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 posted30 Sep 2020
  2. Study start27 Oct 2020
  3. Primary completion10 Oct 2021
  4. Study completion22 Oct 2021

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
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,978 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04571060
Sponsor's protocol ID
BHV3500-301
Other IDs
C5301001
Status last verified
Apr 2023
First submitted
11 Sep 2020
Last updated
24 Apr 2023
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lipton RB, Croop R, Stock DA, Madonia J, Forshaw M, Lovegren M, Mosher L, Coric V, Goadsby PJ. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023 Mar;22(3):209-217. doi: 10.1016/S1474-4422(22)00517-8.

    PubMed 36804093

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zavegepant in people with Migraine, run by Pfizer at 94 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 9 inclusion and 8 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 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 16 Mar 2023). 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 NCT04571060, which also lists 1 linked publication.

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 24 Apr 2023.

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