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NCT03872453 · ClinicalTrials.gov registry record · Phase 2

Acute Treatment Trial in Adult Subjects With Migraines

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
2,154
Enrollment target

NCT03872453: Completed Phase 2 study, sponsored by Pfizer.

NCT03872453 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 2,154 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1520% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03872453, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
2,154 participants
Enrollment target

Study 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.

Primary Outcome

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.

Interventions

  • DRUG Zavegepant
  • DRUG Zavegepant matching placebo
  • DEVICE Intranasal Aptar Pharma Unit Dose System

Trial Details

FieldValue
Enrollment Target 2,154 participants
Start Date 2019-03-25
Est. Completion 2019-11-11
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT03872453 record still lists

NCT03872453 is an interventional study that assigns participants to a tested intervention. Its 2,154 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1520% higher).

The record links to 0 conditions, and to 3 interventions - of which Zavegepant is the first listed.

NCT03872453 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03872453 about?

NCT03872453 is a clinical study titled "Acute Treatment Trial in Adult Subjects With Migraines". 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.

What is the current status of trial NCT03872453?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,154 participants. The study started on 2019-03-25. Estimated completion is 2019-11-11.

What interventions are being tested in trial NCT03872453?

The interventions under investigation include: Zavegepant (DRUG), Zavegepant matching placebo (DRUG), Intranasal Aptar Pharma Unit Dose System (DEVICE).

Who is sponsoring clinical trial NCT03872453?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03872453's enrollment target sits among peer trials

2,154 8th of 2000 higher than 1,993 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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Source: ClinicalTrials.gov NCT03872453, the US trial registry maintained by the National Library of Medicine. NCT03872453 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.