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

Acute Migraine Clinical Trial

Official title:

A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408794
• Other study ID #: BHV3500-202
• Secondary ID: C5301029
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 29, 2020
• Est. completion date: December 23, 2021

Study information

• Verified date: May 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 974
• Est. completion date: December 23, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Drug:
• Zavegepant (BHV-3500)
10 mg IN up to 8 times per month, up to 1 year

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Community Hospital of Anderson and Madison County Inc	Anderson	Indiana
United States	Michigan Headache and Neurological Institute	Ann Arbor	Michigan
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Northwest Clinical Trials Inc.	Boise	Idaho
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Montefiore Medical Center: Headache Center	Bronx	New York
United States	Crescent City Headache and Neurology Center	Chalmette	Louisiana
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	CT Clinical Research	Cromwell	Connecticut
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	OK Clinical Research LLC	Edmond	Oklahoma
United States	Pharmacology Research Institute	Encino	California
United States	Regional Clinical Research	Endwell	New York
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Headache Wellness Center	Greensboro	North Carolina
United States	PharmQuest LLC	Greensboro	North Carolina
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Clinical Investigation Specialist, Inc.	Kenosha	Wisconsin
United States	Volunteer Research Group	Knoxville	Tennessee
United States	eStudySite	La Mesa	California
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Red Star Research LLC	Lake Jackson	Texas
United States	Dartmouth-Hitchcock Heater Road	Lebanon	New Hampshire
United States	Synergy San Diego	Lemon Grove	California
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Community Clinical Research Network	Marlborough	Massachusetts
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Coastal Clinical Research, LLC, An AMR Co.	Mobile	Alabama
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Fieve Clinical Research, Inc	New York	New York
United States	Wr-Pri, Llc	Newport Beach	California
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	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	Summit Research Network	Portland	Oregon
United States	Collective Medical Research	Prairie Village	Kansas
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Wasatch Clinical Research, LLC	Salt Lake City	Utah
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	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Boston Neuro Research Center	South Dartmouth	Massachusetts
United States	J. Lewis Research, Inc. / Jordan River Family Medicine	South Jordan	Utah
United States	Clinvest Research LLC	Springfield	Missouri
United States	Ki Health Partners, LLC dba New England Institute for Clinical Research	Stamford	Connecticut
United States	Meridien Research	Tampa	Florida
United States	DM Clinical Research	Tomball	Texas
United States	Tucson Neuroscience Research	Tucson	Arizona
United States	Preferred Primary Care Physicians, Inc.	Union	Pennsylvania
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Medvadis Research Corporation	Waltham	Massachusetts
United States	Wilmington Health, PLLC	Wilmington	North Carolina
United States	Tekton Research, Inc.	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)