Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine

Phase 2

Completed

• Conditions: Acute Migraine
• Interventions: Drug: Zavegepant (BHV-3500)

• 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

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-05-29
• Study Start: 2020-06-29
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-23
• Disposition First Submitted: 2022-09-25
• Results First Submitted: 2023-02-17
• Results First Submitted QC: 2023-03-15
• Results First Posted: 2023-03-16
• Disposition First Posted: 2023-03-16
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 974

Inclusion Criteria

• 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

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Exclusion 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%

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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.

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