Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
- Registration Number
- NCT04408794
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 974
- 2-8 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
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zavegepant (BHV-3500) Zavegepant (BHV-3500) 10 mg intranasal (IN) up to 8 times per month, up to 1 year
- Primary Outcome Measures
Name Time Method Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation From study drug dosing up to the end of the study (up to 52 weeks) 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.
Number Of Participants With Clinically Significant Laboratory Abnormalities From study drug dosing up to the end of the study (up to 52 weeks) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Ki Health Partners, LLC dba New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Headache Wellness Center
🇺🇸Greensboro, North Carolina, United States
OK Clinical Research LLC
🇺🇸Edmond, Oklahoma, United States
Wilmington Health, PLLC
🇺🇸Wilmington, North Carolina, United States
Tekton Research, Inc.
🇺🇸Yukon, Oklahoma, United States
Clinical Research of Philadelphia, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
🇺🇸Union, Pennsylvania, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Wasatch Clinical Research, LLC
🇺🇸Salt Lake City, Utah, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
Montefiore Medical Center: Headache Center
🇺🇸Bronx, New York, United States
eStudySite
🇺🇸La Mesa, California, United States
Collective Medical Research
🇺🇸Prairie Village, Kansas, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
Boston Neuro Research Center
🇺🇸South Dartmouth, Massachusetts, United States
Community Hospital of Anderson and Madison County Inc
🇺🇸Anderson, Indiana, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Clinical Research Institute, Inc.
🇺🇸Minneapolis, Minnesota, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Dartmouth-Hitchcock Heater Road
🇺🇸Lebanon, New Hampshire, United States
Regional Clinical Research
🇺🇸Endwell, New York, United States
Red Star Research LLC
🇺🇸Lake Jackson, Texas, United States
PharmQuest LLC
🇺🇸Greensboro, North Carolina, United States
Clinical Investigation Specialist, Inc.
🇺🇸Kenosha, Wisconsin, United States
Tucson Neuroscience Research
🇺🇸Tucson, Arizona, United States
Coastal Clinical Research, LLC, An AMR Co.
🇺🇸Mobile, Alabama, United States
Collaborative Neuroscience Network, LLC
🇺🇸Long Beach, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
California Medical Clinic for Headache
🇺🇸Santa Monica, California, United States
Wr-Pri, Llc
🇺🇸Newport Beach, California, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
Michigan Headache and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Medvadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Fieve Clinical Research, Inc
🇺🇸New York, New York, United States
Seattle Women's: Health, Research, Gynecology
🇺🇸Seattle, Washington, United States
CT Clinical Research
🇺🇸Cromwell, Connecticut, United States
Northwest Clinical Trials Inc.
🇺🇸Boise, Idaho, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
🇺🇸Ormond Beach, Florida, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Community Clinical Research Network
🇺🇸Marlborough, Massachusetts, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
Crescent City Headache and Neurology Center
🇺🇸Chalmette, Louisiana, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States