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

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

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 & 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): Medical Affiliated Research Center
🇺🇸
Huntsville, Alabama, United States
Coastal Clinical Research, LLC, An AMR Co.
🇺🇸
Mobile, Alabama, United States
Tucson Neuroscience Research
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Tucson, Arizona, United States
Baptist Health Center for Clinical Research
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Little Rock, Arkansas, United States
Pharmacology Research Institute
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Los Alamitos, California, United States
eStudySite
🇺🇸
La Mesa, California, United States
Synergy San Diego
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Lemon Grove, California, United States
Collaborative Neuroscience Network, LLC
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Long Beach, California, United States
Wr-Pri, Llc
🇺🇸
Newport Beach, California, United States
Artemis Institute for Clinical Research
🇺🇸
San Marcos, California, United States
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Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States