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NCT05989048 | RECRUITING | Migraine

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

Pfizer

Brief 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.

Condition or disease

Migraine

Intervention/treatment

Zavegepant

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1400 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-11-29
Estimated Primary Completion Date : 2025-06-14
Estimated Study Completion Date : 2025-07-19

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults

Location Details

NCT05989048

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Anhui

The Second People's hospital of Hefei

Hefei, Anhui, China, 230011

RECRUITING

China, Beijing

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing, China, 100050

RECRUITING

China, Beijing

The First Medical Center of Chinese PLA General Hospital

Beijing, Beijing, China, 100853

NOT YET RECRUITING

China, Beijing

Chinese PLA General Hospital

Haidian District, Beijing, China, 100853

RECRUITING

China, Chongqing

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing, China, 400016

RECRUITING

China, Hainan

Hainan General Hospital

Haikou, Hainan, China, 570311

RECRUITING

China, Hebei

Renmin Hospital Of Wuhan University

Wuhan, Hebei, China, 430060

RECRUITING

China, Henan

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, Henan, China, 471000

RECRUITING

China, Henan

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, Henan, China, 471003

RECRUITING

China, Henan

People's Hospital of Zhengzhou

Zhengzhou, Henan, China, 450014

RECRUITING

China, Hubei

Wuhan Third Hospital

Wuhan, Hubei, China, 430074

RECRUITING

China, Hunan

Changsha Central Hospital

Changsha, Hunan, China, 410004

RECRUITING

China, Hunan

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

NOT YET RECRUITING

China, Jiangsu

The Second People's Hospital of Lianyungang

Lianyungang, Jiangsu, China, 222002

RECRUITING

China, Jiangsu

The Second People's Hospital of Lianyungang

Lianyungang, Jiangsu, China, 222006

RECRUITING

China, Jiangsu

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210011

RECRUITING

China, Jiangsu

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215004

RECRUITING

China, Jiangsu

Affiliated Hospital of Jiangnan University

Wuxi City,, Jiangsu, China, 214125

RECRUITING

China, Jiangsu

Wuxi People's Hospital

Wuxi, Jiangsu, China, 214023

RECRUITING

China, Jiangsu

The Affiliated Hospital of Jiangsu University

Z is Jiang city, Jiangsu, China, 212008

RECRUITING

China, Jiangxi

Pingxiang People's Hospital

Pingxiang, Jiangxi, China, 337055

RECRUITING

China, Jiangxi

Pingxiang People's Hospital

Pingxiang, Jiangxi, China,

RECRUITING

China, Jilin

The First Hospital of Jilin University

Changchun, Jilin, China, 130000

NOT YET RECRUITING

China, Jilin

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

RECRUITING

China, Liaoning

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China, 110016

NOT YET RECRUITING

China, Liaoning

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China, 110067

RECRUITING

China, n ing X IA province

General Hospital of Ningxia Medical Hospital

Yinchuan, n ing X IA province, China, 750003

RECRUITING

China, n ing lower province

The First People's Hospital of Yinchuan

Yinchuan, n ing lower province, China, 750001

RECRUITING

China, Shaanxi

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710061

RECRUITING

China, Shaanxi

Shaanxi Provincial People' Hospital

Xi'an, Shaanxi, China, 710068

RECRUITING

China, Shaanxi

ξPress GAustralia and New Zealand Hospital

Xi'an, Shaanxi, China, 710075

RECRUITING

China, Shaanxi

Xianyang Hospital of Yan’an University

ξAnyang city,, Shaanxi, China, 716099

RECRUITING

China, Shandong

Qilu Hospital of Shandong University

women, Shandong, China, 250012

RECRUITING

China, Shandong

Jinan Central Hospital

women, Shandong, China, 250013

RECRUITING

China, Shandong

Affiliated Hospital of Jining Medical University

Jining City, Shandong, China, 272000

RECRUITING

China, Shandong

Liaocheng people's Hospital

Done, Shandong, China, 252000

RECRUITING

China, Shandong

Qingdao Central Hospital

Qingdao, Shandong, China, 266042

RECRUITING

China, Shandong

People's Hospital of Rizhao

Rizhao City, Shandong, China, 276800

RECRUITING

China, Shanghai

huAhshan hospital, F Udanuniversity

Shanghai, Shanghai, China, 200040

RECRUITING

China, Shanxi

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China, 046000

RECRUITING

China, Yunnan S Heng

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan S Heng, China, 650032

RECRUITING

China, Zhejiang

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310016

RECRUITING

China, Zhejiang

Ruian People's Hospital

Rui'an, Zhejiang, China, 325200

RECRUITING

China, Zhejiang

The First Affiliated Hosptial of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

RECRUITING

China,

Peking University People's Hospital

Beijing, China, 100044

RECRUITING

China,

Xuanwu Hospital Capital Medical University

Beijing, China, 100053

RECRUITING

China,

Chongqing University Three Gorges Hospital

Chongqing, China, 404000

RECRUITING

China,

The fourth people's hospital of chongqing

Chongqing, China,

RECRUITING

China,

Shanghai East Hospital

Shanghai, China, 200120

RECRUITING

China,

Tianjin Union Medical Center

Tianjin, China, 300000

RECRUITING

Korea, Republic of, Gyeonggi-do

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620

RECRUITING

Korea, Republic of, Kyǒnggi-do

Inje University - Ilsan Paik Hospital

Shake it, Kyǒnggi-do, Korea, Republic of, 10380

RECRUITING

Korea, Republic of, Kyǒnggi-do

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Kyǒnggi-do, Korea, Republic of, 18450

RECRUITING

Korea, Republic of, Kyǒnggi-do

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, Korea, Republic of, 13620

RECRUITING

Korea, Republic of, Kyǒnggi-do

Uijeongbu St. Mary's Hospital

Uijeongbu-si, Kyǒnggi-do, Korea, Republic of, 11765

RECRUITING

Korea, Republic of, Pusan-kwangyǒkshi

Dong-A University Hospital

Busan, Pusan-kwangyǒkshi, Korea, Republic of, 49201

RECRUITING

Korea, Republic of, Seoul-teukbyeolsi [seoul]

Nowon Eulji Medical Center, Eulji University

Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 01830

RECRUITING

Korea, Republic of, Seoul-teukbyeolsi [seoul]

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03080

RECRUITING

Korea, Republic of, Seoul-teukbyeolsi [seoul]

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03722

RECRUITING

Korea, Republic of, Seoul-teukbyeolsi [seoul]

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 05505

RECRUITING

Korea, Republic of, Seoul-teukbyeolsi [seoul]

Ewha Womans University Seoul Hospital

Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 07804

RECRUITING

Korea, Republic of,

Kangbuk Samsung Hospital

Seoul, Korea, Republic of, 03181

NOT YET RECRUITING

Taiwan, Taipei

Tri-Service General Hospital

Taipei City, Taipei, Taiwan, 114

NOT YET RECRUITING

Taiwan,

Chiayi Christian Hospital

No, Taiwan, 600

RECRUITING

Taiwan,

Tri-Service General Hospital

Taipei City, Taiwan, 11490

RECRUITING

Taiwan,

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

NOT YET RECRUITING

Taiwan,

Tri-Service General Hospital

Taipei, Taiwan, 114

RECRUITING

Taiwan,

Chang Gung Medical Foundation-Linkou Branch

tao yuan, Taiwan, 333