At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,154 enrolled
Drug / intervention
Zavegepant +2 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.
Phase II/III: Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine
In Brief
A Phase 3 clinical trial evaluating Zavegepant, Zavegepant matching placebo, and 1 other intervention for Migraine. Completed, enrolled 2,154 participants across 82 sites.
Detailed Summary
The purpose of the study is to evaluate the safety and efficacy of three different intranasal dose levels of zavegepant (BHV-3500), relative to placebo, in the acute treatment of moderate to severe migraine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartMar 2019
Primary CompletionOct 2019
Study CompletionNov 2019
TodayJul 2026
First PostedMar 13, 2019
Enrollment StartMar 25, 2019
Primary CompletionOct 31, 2019
Study CompletionNov 11, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.3 years ago
Interventions
Zavegepantdrug
A single dose of zavegepant
Zavegepant matching placebodrug
A single dose of placebo matched to zavegepant
Intranasal Aptar Pharma Unit Dose Systemdevice
A single-dose intranasal device