NCT05989048

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Zavegepant Intranasal (IN) for the Acute Treatment of Migraine in Asian Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,414 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Migraine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-29
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-08-14
• Last updated: 2025-08-13

Locations

61 sites across 3 countries: China, South Korea, Taiwan

Regulatory

• FDA-regulated drug study