CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 974 enrolled
Drug / intervention
Zavegepant (BHV-3500)drug
Likely dose
Zavegepant (BHV-3500) 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04408794
NCT04408794Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted May 29, 2020·Updated May 18, 2023

In Brief

A Phase 3 clinical trial evaluating Zavegepant (BHV-3500) for Acute Migraine. Completed, enrolled 974 participants across 67 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Migraine
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMay 29, 2020
Enrollment StartJun 29, 2020
Primary CompletionDec 9, 2021
Study CompletionDec 23, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.1 years ago

Interventions

Zavegepant (BHV-3500)drug

10 mg IN up to 8 times per month, up to 1 year