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

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.

Study Overview

• Status: Completed
• Conditions: Acute Migraine
• Intervention / Treatment: Drug: Zavegepant (BHV-3500)

• Study Type: Interventional
• Enrollment (Actual): 974
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, LLC, An AMR Co.
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Tucson Neuroscience Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • La Mesa, California, United States, 91942
      • eStudySite
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Newport Beach, California, United States, 92660
      • Wr-Pri, Llc
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Marcos, California, United States, 92078
      • Artemis Institute for Clinical Research
    • Santa Monica, California, United States, 90404
      • California Medical Clinic for Headache
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc.
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • CT Clinical Research
    • Stamford, Connecticut, United States, 06905
      • Ki Health Partners, LLC dba New England Institute for Clinical Research
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Lake City, Florida, United States, 32055
      • Multi-Specialty Research Associates, Inc.
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Orlando, Florida, United States, 32819
      • Clinical Neuroscience Solutions, Inc.
    • Ormond Beach, Florida, United States, 32174
      • Ormond Medical Arts Pharmaceutical Research Center
    • Tampa, Florida, United States, 33634
      • Meridien Research
  • Georgia
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research, LLC
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials Inc.
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Community Hospital of Anderson and Madison County Inc
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Neurological Center
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • Collective Medical Research
  • Louisiana
    • Chalmette, Louisiana, United States, 70043
      • Crescent City Headache and Neurology Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Marlborough, Massachusetts, United States, 01752
      • Community Clinical Research Network
    • South Dartmouth, Massachusetts, United States, 02747
      • Boston Neuro Research Center
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corporation
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Headache and Neurological Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc.
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
    • Springfield, Missouri, United States, 65810
      • Clinvest Research LLC
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Heater Road
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center: Headache Center
    • Endwell, New York, United States, 13760
      • Regional Clinical Research
    • New York, New York, United States, 10017
      • Fieve Clinical Research, Inc
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest LLC
    • Wilmington, North Carolina, United States, 28401
      • Wilmington Health, PLLC
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research LLC
    • Yukon, Oklahoma, United States, 73099
      • Tekton Research, Inc.
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Of Philadelphia, Llc
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Inc.
    • Union, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians, Inc.
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • Lake Jackson, Texas, United States, 77566
      • Red Star Research LLC
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research, LLC
    • South Jordan, Utah, United States, 84095
      • J. Lewis Research, Inc. / Jordan River Family Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center, LLC
    • Virginia Beach, Virginia, United States, 23454
      • Tidewater Integrated Medical Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Seattle, Washington, United States, 98105
      • Seattle Women's: Health, Research, Gynecology
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Clinical Investigation Specialist, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zavegepant (BHV-3500); 10 mg intranasal (IN) up to 8 times per month, up to 1 year	Drug: Zavegepant (BHV-3500); 10 mg IN up to 8 times per month, up to 1 year; Other Names: Vazegepant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 23, 2021

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: migraine, headache, intranasal
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: BHV3500-202; C5301029 (Other Identifier: Pfizer)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No