Trials / Completed

CompletedNCT04408794

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

Status: Completed
Phase: Phase 2 / Phase 3
Study type: Interventional
Enrollment: 974 (actual)

Sponsor: Pfizer · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Acute Migraine

Interventions

Type	Name	Description
DRUG	Zavegepant (BHV-3500)	10 mg IN up to 8 times per month, up to 1 year

Timeline

Start date: 2020-06-29
Primary completion: 2021-12-09
Completion: 2021-12-23
First posted: 2020-05-29
Last updated: 2023-05-18
Results posted: 2023-03-16

Locations

67 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04408794. Inclusion in this directory is not an endorsement.