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Acute Treatment Trial in Adult Subjects With Migraines

NCT03872453 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 2154

Last updated 2023-09-25

Study results available
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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.

Conditions

Interventions

DRUG

Zavegepant

A single dose of zavegepant

DRUG

Zavegepant matching placebo

A single dose of placebo matched to zavegepant

DEVICE

Intranasal Aptar Pharma Unit Dose System

A single-dose intranasal device

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2019-10-31
Completion
2019-11-11
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03872453 on ClinicalTrials.gov