At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,978 enrolled
Drug / intervention
Zavegepant +1 moredrug
Likely dose
Not stated in 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.
Double-Blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal for the Acute Treatment of Migraine
In Brief
A Phase 3 clinical trial evaluating Zavegepant and Placebo for Migraine. Completed, enrolled 1,978 participants across 94 sites.
Detailed Summary
The purpose of this study is to test the safety and efficacy of BHV-3500 (zavegepant) versus placebo in the acute treatment of moderate or severe migraine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartOct 2020
Primary CompletionOct 2021
Study CompletionOct 2021
TodayJul 2026
First PostedSep 30, 2020
Enrollment StartOct 27, 2020
Primary CompletionOct 10, 2021
Study CompletionOct 22, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.8 years ago
Interventions
Zavegepantdrug
One dose of zavegepant
Placebodrug
One dose of matching placebo