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COMPLETED

NCT05989048

PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1414

Start Date

2023-11-29

Completion Date

2025-05-30

Last Updated

2026-05-22

Healthy Volunteers

Conditions

Migraine

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.

Inclusion Criteria: * Asian participants aged 18 years or older at screening. * Participants with minimum 1 year history of migraine (with or without aura) prior to the Screening Visit, consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following: 1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age. 2. Migraine attacks, on average, lasting about 4-72 hours if untreated. 3. Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months. 4. Participants must be able to distinguish migraine attacks from tension/cluster headaches. 5. At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report). 6. Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report). 7. Participants on prophylactic migraine medication are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to Screening Visit, and if the dose is not expected to change through the End of Treatment Visit. 8. Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria. Exclusion Criteria: * History of retinal migraine, basilar migraine or hemiplegic migraine. * History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease. * Major depressive disorder, anxiety disorder, or other significant psychiatric disorder. * Acute or chronic pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that interfere with study assessments. * Conditions that may affect the administration or absorption of the nasal product. * Medication overuse headaches.

Locations (61)

The Second People's hospital of Hefei

Hefei, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Hainan General Hospital

Haikou, Hainan, China

Renmin Hospital Of Wuhan University

Wuhan, Hebei, China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, Henan, China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, Henan, China

People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Wuhan Third Hospital

Wuhan, Hubei, China

Changsha Central Hospital

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The Second People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

The Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China

General Hospital of Ningxia Medical Hospital

Yinchuan, Ningxia, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shaanxi Provincial People' Hospital

Xi'an, Shaanxi, China

Xian Gaoxin Hospital

Xi'an, Shaanxi, China

Xianyang Hospital of Yan'an University

Xianyang, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Liaocheng people's Hospital

Liaocheng, Shandong, China

Qingdao Central Hospital

Qingdao, Shandong, China

People's Hospital of Rizhao

Rizhao, Shandong, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Ruian People's Hospital

Rui’an, Zhejiang, China

The First Affiliated Hosptial of Wenzhou Medical University

Wenzhou, Zhejiang, China

Peking University People's Hospital

Beijing, China

Xuanwu Hospital Capital Medical University

Beijing, China

Chongqing University Three Gorges Hospital

Chongqing, China

The fourth people's hospital of chongqing

Chongqing, China

Shanghai East Hospital

Shanghai, China

Tianjin Union Medical Center

Tianjin, China

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Inje University - Ilsan Paik Hospital

Goyang-si, Kyǒnggi-do, South Korea

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Kyǒnggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Uijeongbu-si, Kyǒnggi-do, South Korea

Dong-A University Hospital

Busan, Pusan-kwangyǒkshi, South Korea

Nowon Eulji Medical Center, Eulji University