Study Stopped
Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
A Phase 2/3 Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
2 other identifiers
interventional
1,753
1 country
116
Brief Summary
The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.
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 2021
Typical duration for phase_2
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 18, 2021
CompletedStudy Start
First participant enrolled
March 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2024
CompletedResults Posted
Study results publicly available
March 27, 2025
CompletedMarch 27, 2025
March 1, 2025
3 years
March 5, 2021
March 6, 2025
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. \>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \>= 1 of following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28\*(total number of migraine days through Month 3\[Weeks 1 to 12\] in on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3\[Weeks 1 to 12\] in the on-DBT efficacy analysis period).
Observation Phase: 28 days prior to randomization and baseline; Entire DBT Phase: 12 weeks (Week 1 through 12)
Secondary Outcomes (20)
Percentage of Participants With >= 50 % Reduction in Number of Moderate to Severe Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
Entire DBT Phase: 12 weeks (Week 1 through 12)
Mean Change From Observation Phase in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase
Observation Phase: 28 days prior to randomization and baseline; DBT Phase: last 4 weeks (Week 9 through 12)
Mean Change From Observation Phase in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase
Observation Phase: 28 days prior to randomization and baseline; DBT Phase: first 4 weeks (Week 1 through 4)
Mean Number of Acute Migraine -Specific Medication Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
Entire DBT Phase: 12 weeks (Week 1 through 12)
Mean Change From Baseline in the Migraine-specific Quality of Life Questionnaire (MSQ) v 2.1 Restrictive Role Function Domain Score at Week 12
DBT Phase: Baseline (before dose on Day 1), Week 12
- +15 more secondary outcomes
Study Arms (4)
BHV-3500 200mg
ACTIVE COMPARATORZavegepant 200mg oral soft gel capsule.
Placebo 200mg
PLACEBO COMPARATORMatching placebo 200mg oral soft gel capsule.
BHV-3500 100mg
ACTIVE COMPARATORZavegepant 100mg oral soft gel capsule.
Placebo 100mg
PLACEBO COMPARATORMatching placebo 100mg oral soft gel capsule.
Interventions
Eligibility Criteria
You may qualify if:
- Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of
- Headache Disorders, 3rd Edition, including the following:
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4 - 72 hours if untreated
- Per subject report, at least 15 headache days per month, at lest 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit
- Eight or more migraine days during the Observation Period
- or more headache days during the Observation Period
- One or more non-headache days during the Observation Period
- Ability to distinguish migraine attacks from tension/cluster headaches
- Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.
You may not qualify if:
- Subject with a history of HIV disease
- Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects 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 subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
- Subjects with major depressive episode or anxiety disorder which require more than 1 daily medication for each disorder or subjects with a major depressive episode within the last 12 months. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit.
- Subjects with active chronic pain syndromes, other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion interfere with study assessments of safety or efficacy.
- Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
- Body mass index \> 33 kg/m2
- History of gallstones or cholecystectomy.
- The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or 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 (AE) or interfere with assessments of safety or efficacy during the course of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (116)
Xenoscience, Inc
Phoenix, Arizona, 85004, United States
Tucson Neuroscience Research
Tucson, Arizona, 85710, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Axiom Research, Llc
Colton, California, 92324, United States
Wr-Pri, Llc
Encino, California, 91316, United States
eStudySite
La Mesa, California, 91942, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
Collaborative Neuroscience Research, LLC.
Long Beach, California, 90806, United States
Clinical Research Institute
Los Angeles, California, 90048, United States
Wr-Pri, Llc
Newport Beach, California, 92660, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
California Neuroscience Research Medical Group, inc.
Sherman Oaks, California, 91403, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428, United States
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida, 32132, United States
Complete Health Research
Edgewater, Florida, 32132, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
AppleMed Research Group, LLC
Miami, Florida, 33126, United States
AppleMed Research Group, LLC
Miami, Florida, 33155, United States
Brainstorm Research
Miami, Florida, 33176, United States
The Neurology Research Group
Miami, Florida, 33176, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Complete Health Research
Ormond Beach, Florida, 32174, United States
Ideal Clinical Research
Pembroke Pines, Florida, 33026, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
Clin-Med Research & Development LLC
South Miami, Florida, 33143, United States
Accel Research Sites Network - St. Petersburg Clinical Research Unit
St. Petersburg, Florida, 33709, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
JSV Clinical Research Study Inc
Tampa, Florida, 33634, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
iResearch Atlanta LLC
Decatur, Georgia, 30030, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031, United States
Clinical Investigation Specialists, Inc
Gurnee, Illinois, 60031, United States
MediSphere Medical Research Center, LLC.
Evansville, Indiana, 47714, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Meridian Clinical Research, LLC
Sioux City, Iowa, 51106, United States
Alliance for Multispecialty Reseach, LLC
El Dorado, Kansas, 67042, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114, United States
Collevtive Medical Research
Overland Park, Kansas, 66210, United States
Kansas Institute of Research
Overland Park, Kansas, 66211, United States
The Research Group of Lexington, Llc.
Lexington, Kentucky, 40503, United States
The Research Group of Lexington, Llc
Lexington, Kentucky, 40503, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Crescent City Headache and Neurology Center
Chalmette, Louisiana, 70043, United States
Alliance for Multispecialty Research, LLC.
New Orleans, Louisiana, 70119, United States
DelRicht Research
New Orleans, Louisiana, 70124, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Neurology Center of New England P.C.
Foxborough, Massachusetts, 02035, United States
Community Clinical Research Network Inc
Marlborough, Massachusetts, 01752, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Romedica LLC
Rochester, Michigan, 48307, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Alliance for Multispecialty Reseach, LLC
Kansas City, Missouri, 64114, United States
Clinvest Research, LLC
Springfield, Missouri, 65807, United States
Clinvest Research, LLC
Springfield, Missouri, 65810, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701, United States
Excel Clinical research
Las Vegas, Nevada, 89109, United States
Wr-Crcn, Llc
Las Vegas, Nevada, 89118, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, 14226, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
New York Neurology Associates
New York, New York, 10003, United States
Fieve Clinical Research, Inc
New York, New York, 10017, United States
North Suffolk Neurology, PC
Port Jefferson Station, New York, 11776, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221, United States
Headache Wellness Center
Greensboro, North Carolina, 27405, United States
Accellacare
Raleigh, North Carolina, 27609, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Carolina Research Center, Inc.
Shelby, North Carolina, 28150, United States
Accellacare
Wilmington, North Carolina, 28401, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
WellNow Urgent Care and Research
Cincinnati, Ohio, 45215, United States
Wellnow Urgent Care
Cincinnati, Ohio, 45215, United States
Hometown Urgent Care and Research
Columbus, Ohio, 43214, United States
Wellnow Urgent Care and Research
Columbus, Ohio, 43214, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45424, United States
WellNow Urgent Care and Research
Dayton, Ohio, 45424, United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720, United States
WellNow Urgent Care and Research
Troy, Ohio, 45373, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73134, United States
Summit Headlands LLC, dba Summit Research
Portland, Oregon, 97210, United States
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Reading Hospital Clinical Trials Office
West Reading, Pennsylvania, 19611, United States
Tower Health Medical Group - Neurology
West Reading, Pennsylvania, 19611, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Accellacare (Administrative Only)
Bristol, Tennessee, 37620, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
KCA Neurology, PLLC
Franklin, Tennessee, 37067, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
North Texas Institute of Neurology and Headache - NextStage Clinical Research
Frisco, Texas, 75034, United States
North Texas Institute of Neurology and Headache
Frisco, Texas, 75034, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Red Star Research. LLC
Lake Jackson, Texas, 77566, United States
FMC Science
Lampasas, Texas, 76550, United States
Radiance Clinical Research
Lampasas, Texas, 76550, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Wasatch Clinical Research , LLC(Administrative Location)
Salt Lake City, Utah, 84107, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
Meridian Clinical Research, LLC
Norfolk, Virginia, 23502, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Seattle Clinical Research Center
Seattle, Washington, 98105, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2021
First Posted
March 18, 2021
Study Start
March 26, 2021
Primary Completion
March 21, 2024
Study Completion
March 21, 2024
Last Updated
March 27, 2025
Results First Posted
March 27, 2025
Record last verified: 2025-03
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.