Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
2154 participants
INTERVENTIONAL
2019-03-25
2019-11-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Trial in Adult Participants With Acute Migraines
NCT04571060
Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
NCT04408794
A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
NCT04804033
Safety and Efficacy in Adult Subjects With Acute Migraines
NCT03237845
Safety and Efficacy Study in Adult Subjects With Acute Migraines
NCT03235479
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Zavegepant 5 mg
Participants 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.
Zavegepant
A single dose of zavegepant
Intranasal Aptar Pharma Unit Dose System
A single-dose intranasal device
Zavegepant 10 mg
Participants 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.
Zavegepant
A single dose of zavegepant
Intranasal Aptar Pharma Unit Dose System
A single-dose intranasal device
Zavegepant 20 mg
Participants 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.
Zavegepant
A single dose of zavegepant
Intranasal Aptar Pharma Unit Dose System
A single-dose intranasal device
Placebo
Participants 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.
Zavegepant matching placebo
A single dose of placebo matched to zavegepant
Intranasal Aptar Pharma Unit Dose System
A single-dose intranasal device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zavegepant
A single dose of zavegepant
Zavegepant matching placebo
A single dose of placebo matched to zavegepant
Intranasal Aptar Pharma Unit Dose System
A single-dose intranasal device
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
2. Migraine attacks, on average, lasting about 4-72 hours if untreated.
3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months.
4. 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.
5. 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.
6. 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.
7. Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion Criteria
2. Participant with a history of human immunodeficiency virus (HIV) disease.
3. 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.
4. 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).
5. 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.
6. 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.
7. 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.
8. 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.
9. History of nasal surgery in the 6 months preceding the Screening Visit.
10. Participation in any other investigational clinical trial while participating in this clinical trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Pharmacology Research Institute
Encino, California, United States
eStudySite
La Mesa, California, United States
Synergy San Diego
Lemon Grove, California, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
National Research Institute
Panorama City, California, United States
Optimus Medical Group
San Francisco, California, United States
Neurological Research Institute
Santa Monica, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Denver Neurological Research, LLC
Denver, Colorado, United States
CT Clinical Research
Cromwell, Connecticut, United States
Ki Health Partners, LLC, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
MD Clinical
Hallandale, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
AGA Clinical Trials
Miami, Florida, United States
Qps Mra, Llc
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States
Meridien Research
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Family Medicine Specialists/CIS
Wauconda, Illinois, United States
Phoenix Medical Research
Prairie Village, Kansas, United States
Crescent City Headache and Neurology Center, LLC
Chalmette, Louisiana, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Community Clinical Research Network
Marlborough, Massachusetts, United States
Regeneris Medical
North Attleboro, Massachusetts, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Clinical Research Institute, Inc.
Plymouth, Minnesota, United States
MedPharmics, LLC
Biloxi, Mississippi, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, United States
Meritas Health Neurology
North Kansas City, Missouri, United States
QPS Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, United States
Clinvest Research LLC
Springfield, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Dent Neurosciences Research Center
Amherst, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Montefiore Medical Center: Headache Center
The Bronx, New York, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
Headache Wellness Center
Greensboro, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, United States
Hometown Urgent Care and Research
Columbus, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, United States
Alliance for Multispecialty Research/New Orleans Center for Clinical Research/Volunteer Research
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions DBA CNS Healthcare
Memphis, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Ventavia Research Group
Fort Worth, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Red Star Research, LLC
Lake Jackson, Texas, United States
Advanced Pharmaceutical Development Clinical Research
Magnolia, Texas, United States
Victorium Clinical Research
San Antonio, Texas, United States
Dynamed Clinical Research
Tomball, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Northwest Clinical Research
Bellevue, Washington, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BHV3500-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.