18 and older, any sex, with Acute Migraine. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To DiscontinuationPrimary· 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
AEs
Group
Value
95% CI
Zavegepant 10 mg
460
SAEs
Group
Value
95% CI
Zavegepant 10 mg
7
AEs leading to discontinuation
Group
Value
95% CI
Zavegepant 10 mg
41
Number Of Participants With Clinically Significant Laboratory AbnormalitiesPrimary· 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
Alanine Aminotransferase
Group
Value
95% CI
Zavegepant 10 mg
3
Aspartate Aminotransferase
Group
Value
95% CI
Zavegepant 10 mg
5
Albumin
Group
Value
95% CI
Zavegepant 10 mg
0
Alkaline Phosphatase
Group
Value
95% CI
Zavegepant 10 mg
0
Bicarbonate
Group
Value
95% CI
Zavegepant 10 mg
0
Biliburin
Group
Value
95% CI
Zavegepant 10 mg
0
Calcium, low
Group
Value
95% CI
Zavegepant 10 mg
0
Calcium, high
Group
Value
95% CI
Zavegepant 10 mg
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From study drug dosing up to the end of the study (up to 52 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04346615 — Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxyge
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 18 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04408794.