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A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults

NCT05989048 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1414

Last updated 2026-05-22

Study results available
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Summary

The purpose of this study is to learn how safe and effective zavegepant is compared to placebo in the acute treatment of migraine in Asian adults. Migraine is a very painful headache with other associated symptoms such as nausea, photophobia and phonophobia. A placebo is a harmless treatment that has no medical effect.

This study is seeking for participants who:

* have at least 1 year of migraine history before entering the study.
* have 2 to 8 migraine headache attacks of moderate or severe intensity in each of the 3 months before entering the study.
* have less than 15 days with headaches in each of the 3 months before entering the study. The headaches could be either due to migraine or not.

The participants in this study will receive zavegepant or placebo through intranasal route. Intranasal means medicine which is given through nose. Zavegepant or placebo will be taken if the participants have a migraine headache of moderate or severe intensity.

The study will compare the experiences of people receiving zavegepant to those of the people receiving placebo. This will help see if zavegepant is safe and effective in Asian adults.

Participants will be in this study for up to about 16 weeks. Participants will have 3 study visits at the study clinic and 1 through telephone contact.

Conditions

Interventions

DRUG

Zavegepant

The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.

DRUG

Placebo

Single dose of matching placebo taken within Treatment Phase.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2025-05-30
Completion
2025-05-30
FDA Drug
Yes

Countries

  • China
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
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 NCT05989048 on ClinicalTrials.gov