Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
NCT ID: NCT04408794
Last Updated: 2023-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
974 participants
INTERVENTIONAL
2020-06-29
2021-12-23
Brief Summary
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\* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zavegepant (BHV-3500)
10 mg intranasal (IN) up to 8 times per month, up to 1 year
Zavegepant (BHV-3500)
10 mg IN up to 8 times per month, up to 1 year
Interventions
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Zavegepant (BHV-3500)
10 mg IN up to 8 times per month, up to 1 year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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%
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Locations
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Medical Affiliated Research Center
Huntsville, Alabama, United States
Coastal Clinical Research, LLC, An AMR Co.
Mobile, Alabama, United States
Tucson Neuroscience Research
Tucson, 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
Wr-Pri, Llc
Newport Beach, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
CT Clinical Research
Cromwell, Connecticut, United States
Ki Health Partners, LLC dba New England Institute for Clinical Research
Stamford, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, 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
iResearch Atlanta, LLC
Decatur, Georgia, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Northwest Clinical Trials Inc.
Boise, Idaho, United States
Community Hospital of Anderson and Madison County Inc
Anderson, Indiana, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Collective Medical Research
Prairie Village, Kansas, United States
Crescent City Headache and Neurology Center
Chalmette, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Community Clinical Research Network
Marlborough, Massachusetts, United States
Boston Neuro Research Center
South Dartmouth, Massachusetts, United States
Medvadis Research Corporation
Waltham, Massachusetts, United States
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Clinvest Research LLC
Springfield, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Dartmouth-Hitchcock Heater Road
Lebanon, New Hampshire, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Regional Clinical Research
Endwell, New York, United States
Fieve Clinical Research, Inc
New York, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Montefiore Medical Center: Headache Center
The Bronx, New York, United States
Headache Wellness Center
Greensboro, North Carolina, United States
PharmQuest LLC
Greensboro, North Carolina, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States
OK Clinical Research LLC
Edmond, Oklahoma, United States
Tekton Research, Inc.
Yukon, Oklahoma, United States
Summit Research Network
Portland, Oregon, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Union, Pennsylvania, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Red Star Research LLC
Lake Jackson, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States
Clinical Investigation Specialist, Inc.
Kenosha, Wisconsin, United States
Countries
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References
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Mullin 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C5301029
Identifier Type: OTHER
Identifier Source: secondary_id
BHV3500-202
Identifier Type: -
Identifier Source: org_study_id
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