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NCT04408794 · ClinicalTrials.gov registry record · Phase 2
Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 974
- Enrollment target
NCT04408794: Completed Phase 2 study, sponsored by Pfizer.
NCT04408794 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 974 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (632% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04408794, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 974 participants
- Enrollment target
Study 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.
Primary Outcome
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 disabili
Interventions
- DRUG Zavegepant (BHV-3500)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 974 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2021-12-23 |
| Phase | Phase 2 |
What the finished NCT04408794 record still lists
NCT04408794 is an interventional study that assigns participants to a tested intervention. The registered 974 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (632% higher).
The record links to 0 conditions, and to 1 intervention - of which Zavegepant (BHV-3500) is the first listed.
NCT04408794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04408794 about?
NCT04408794 is a clinical study titled "Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine". 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) E...
What is the current status of trial NCT04408794?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 974 participants. The study started on 2020-06-29. Estimated completion is 2021-12-23.
What interventions are being tested in trial NCT04408794?
The interventions under investigation include: Zavegepant (BHV-3500) (DRUG).
Who is sponsoring clinical trial NCT04408794?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04408794's enrollment target sits among peer trials
974 28th of 2000 higher than 1,973 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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