Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine
2 other identifiers
interventional
974
1 country
67
Brief Summary
The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine. \* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
Shorter than P25 for phase_2
67 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
May 26, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedStudy Start
First participant enrolled
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2021
CompletedResults Posted
Study results publicly available
March 16, 2023
CompletedMay 18, 2023
May 1, 2023
1.4 years
May 26, 2020
February 17, 2023
May 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes.
From study drug dosing up to the end of the study (up to 52 weeks)
Number Of Participants With Clinically Significant Laboratory Abnormalities
Clinically significant laboratory abnormalities were defined as Grades 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome. Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, low-density lipoprotein (LDL)-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in to be included for a given parameter. Laboratory results were presented in US units.
From study drug dosing up to the end of the study (up to 52 weeks)
Study Arms (1)
Zavegepant (BHV-3500)
EXPERIMENTAL10 mg intranasal (IN) up to 8 times per month, up to 1 year
Interventions
10 mg IN up to 8 times per month, up to 1 year
Eligibility Criteria
You may qualify if:
- moderate to severe migraines/month within the last 3 months
- Migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting about 4-72 hours if untreated
- Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit
- Ability to distinguish migraine attacks from tension/cluster headaches
- Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria
You may not qualify if:
- History of human immunodeficiency virus disease
- History of basilar or hemiplegic migraine
- Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
- History of nasal surgery in the 6 months preceding the screening visit
- History of gallstones or cholecystectomy
- History of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etcetera), or other disease or condition (for example, chronic pancreatitis, ulcerative colitis, etcetera) that causes malabsorption.
- Body mass index ≥ 33
- Hemoglobin A1c ≥6.5%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (67)
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
Coastal Clinical Research, LLC, An AMR Co.
Mobile, Alabama, 36608, United States
Tucson Neuroscience Research
Tucson, Arizona, 85710, 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
Wr-Pri, Llc
Newport Beach, California, 92660, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Artemis Institute for Clinical Research
San Marcos, California, 92078, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, 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
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32819, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174, United States
Meridien Research
Tampa, Florida, 33634, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Northwest Clinical Trials Inc.
Boise, Idaho, 83704, United States
Community Hospital of Anderson and Madison County Inc
Anderson, Indiana, 46011, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804, United States
Collective Medical Research
Prairie Village, Kansas, 66208, United States
Crescent City Headache and Neurology Center
Chalmette, Louisiana, 70043, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Community Clinical Research Network
Marlborough, Massachusetts, 01752, United States
Boston Neuro Research Center
South Dartmouth, Massachusetts, 02747, United States
Medvadis Research Corporation
Waltham, Massachusetts, 02451, United States
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65810, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Dartmouth-Hitchcock Heater Road
Lebanon, New Hampshire, 03766, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Regional Clinical Research
Endwell, New York, 13760, United States
Fieve Clinical Research, Inc
New York, New York, 10017, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Montefiore Medical Center: Headache Center
The Bronx, New York, 10461, United States
Headache Wellness Center
Greensboro, North Carolina, 27405, United States
PharmQuest LLC
Greensboro, North Carolina, 27408, United States
Wilmington Health, PLLC
Wilmington, North Carolina, 28401, United States
OK Clinical Research LLC
Edmond, Oklahoma, 73034, United States
Tekton Research, Inc.
Yukon, Oklahoma, 73099, United States
Summit Research Network
Portland, Oregon, 97210, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236, United States
Preferred Primary Care Physicians, Inc.
Union, Pennsylvania, 15401, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, 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
Red Star Research LLC
Lake Jackson, Texas, 77566, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, 84095, 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 Center
Bellevue, Washington, 98007, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105, United States
Clinical Investigation Specialist, Inc.
Kenosha, Wisconsin, 53144, United States
Related Publications (2)
Lipton RB, Mosher L, Fountaine RJ. Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week, Open-Label Study. Pain Ther. 2025 Dec 11. doi: 10.1007/s40122-025-00800-z. Online ahead of print.
PMID: 41379282DERIVEDMullin K, Croop R, Mosher L, Fullerton T, Madonia J, Lipton RB. Long-term safety of zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 open-label study. Cephalalgia. 2024 Aug;44(8):3331024241259456. doi: 10.1177/03331024241259456.
PMID: 39210835DERIVED
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2020
First Posted
May 29, 2020
Study Start
June 29, 2020
Primary Completion
December 9, 2021
Study Completion
December 23, 2021
Last Updated
May 18, 2023
Results First Posted
March 16, 2023
Record last verified: 2023-05