Acute Treatment Trial in Adult Subjects With Migraines
Phase II/III: Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine
1 other identifier
interventional
2,154
1 country
82
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2019
Shorter than P25 for phase_2
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2019
CompletedResults Posted
Study results publicly available
October 13, 2022
CompletedSeptember 25, 2023
September 1, 2023
7 months
March 6, 2019
September 14, 2022
September 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
2 hours post-dose
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.
2 hours post-dose
Secondary Outcomes (15)
Percentage of Participants With Pain Relief at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
Through 24 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
2 hours post-dose
- +10 more secondary outcomes
Study Arms (4)
Zavegepant 5 mg
EXPERIMENTALParticipants 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 10 mg
EXPERIMENTALParticipants 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 20 mg
EXPERIMENTALParticipants 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.
Placebo
PLACEBO 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.
Interventions
A single dose of zavegepant
A single-dose intranasal device
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (82)
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Pharmacology Research Institute
Encino, California, 91316, United States
eStudySite
La Mesa, California, 91942, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
National Research Institute
Panorama City, California, 91402, United States
Optimus Medical Group
San Francisco, California, 94102, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Denver Neurological Research, LLC
Denver, Colorado, 80210, United States
CT Clinical Research
Cromwell, Connecticut, 06416, United States
Ki Health Partners, LLC, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
MD Clinical
Hallandale, Florida, 33009, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
AGA Clinical Trials
Miami, Florida, 33012, United States
Qps Mra, Llc
Miami, Florida, 33143, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174, United States
Meridien Research
Tampa, Florida, 33634, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Meridian Clinical Research
Savannah, Georgia, 31405, United States
Family Medicine Specialists/CIS
Wauconda, Illinois, 60084, United States
Phoenix Medical Research
Prairie Village, Kansas, 66208, United States
Crescent City Headache and Neurology Center, LLC
Chalmette, Louisiana, 70043, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
DelRicht Research
New Orleans, Louisiana, 70124, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Community Clinical Research Network
Marlborough, Massachusetts, 01752, United States
Regeneris Medical
North Attleboro, Massachusetts, 02169, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Clinical Research Institute, Inc.
Plymouth, Minnesota, 55441, United States
MedPharmics, LLC
Biloxi, Mississippi, 39531, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114, United States
Meritas Health Neurology
North Kansas City, Missouri, 64116, United States
QPS Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, 65802, United States
Clinvest Research LLC
Springfield, Missouri, 65810, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Montefiore Medical Center: Headache Center
The Bronx, New York, 10461, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
Headache Wellness Center
Greensboro, North Carolina, 27405, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
Wilmington Health, PLLC
Wilmington, North Carolina, 28401, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215, United States
Hometown Urgent Care and Research
Columbus, Ohio, 43214, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45424, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73134, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon, 97301, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049, United States
Alliance for Multispecialty Research/New Orleans Center for Clinical Research/Volunteer Research
Knoxville, Tennessee, 37920, United States
Clinical Neuroscience Solutions DBA CNS Healthcare
Memphis, Tennessee, 38119, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
Ventavia Research Group
Fort Worth, Texas, 76104, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Red Star Research, LLC
Lake Jackson, Texas, 77566, United States
Advanced Pharmaceutical Development Clinical Research
Magnolia, Texas, 77355, United States
Victorium Clinical Research
San Antonio, Texas, 78230, United States
Dynamed Clinical Research
Tomball, Texas, 77375, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Northwest Clinical Research
Bellevue, Washington, 98007, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53144, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Biohaven Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-blind to Sponsor, Investigator and Subject
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2019
First Posted
March 13, 2019
Study Start
March 25, 2019
Primary Completion
October 31, 2019
Study Completion
November 11, 2019
Last Updated
September 25, 2023
Results First Posted
October 13, 2022
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
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.