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

Last updated: October 5, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Oral Facial Pain

Chronic Pain

Headaches

Treatment

Placebo

Zavegepant

Clinical Study ID

NCT05989048
C5301008
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Asian participants aged 18 years or older at screening.

  • Participants with minimum 1 year history of migraine (with or without aura) prior tothe Screening Visit, consistent with a diagnosis according to the InternationalClassification of Headache Disorders, 3rd Edition, including the following:

  1. Migraine attacks present for more than 1 year with the age of onset prior to 50years 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 withinlast 3 months.

  4. Participants must be able to distinguish migraine attacks from tension/clusterheadaches.

  5. At least 2 consistent migraine headache attacks of moderate or severe intensityin each of the 3 months prior to the Screening Visit and throughout theScreening Phase (participant self-report).

  6. Less than 15 days with headaches (migraine or non-migraine) per month in eachof 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 ontherapy if they have been on a stable dose for at least 3 months prior toScreening Visit, and if the dose is not expected to change through the End ofTreatment Visit.

  8. Participants with contraindications for use of triptans may be includedprovided they meet all other study entry criteria.

Exclusion

Exclusion Criteria:

  • History of retinal migraine, basilar migraine or hemiplegic migraine.

  • History or current evidence of uncontrolled, unstable or recently diagnosedcardiovascular or cardiometabolic disease.

  • Major depressive disorder, anxiety disorder, or other significant psychiatricdisorder.

  • Acute or chronic pain syndromes, psychiatric conditions, dementia, or significantneurological disorders (other than migraine) that interfere with study assessments.

  • Conditions that may affect the administration or absorption of the nasal product.

  • Medication overuse headaches.

Study Design

Total Participants: 1400
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 29, 2023
Estimated Completion Date:
July 19, 2025

Connect with a study center

  • The Second People's hospital of Hefei

    Hefei, Anhui 230011
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • The First Medical Center of Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

  • Chinese PLA General Hospital

    Haidian District, Beijing 100853
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Active - Recruiting

  • Hainan General Hospital

    Haikou, Hainan 570311
    China

    Active - Recruiting

  • Renmin Hospital Of Wuhan University

    Wuhan, Hebei 430060
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan 471000
    China

    Active - Recruiting

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan 450014
    China

    Active - Recruiting

  • Wuhan Third Hospital

    Wuhan, Hubei 430074
    China

    Active - Recruiting

  • Changsha Central Hospital

    Changsha, Hunan 410004
    China

    Active - Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu 222006
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215004
    China

    Active - Recruiting

  • Wuxi People's Hospital

    Wuxi, Jiangsu 214023
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi City,, Jiangsu 214125
    China

    Active - Recruiting

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang City, Jiangsu 212008
    China

    Active - Recruiting

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi 337055
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin 130000
    China

    Active - Recruiting

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning 110016
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical Hospital

    Yinchuan, NING XIA Province 750003
    China

    Active - Recruiting

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia Province 750001
    China

    Active - Recruiting

  • Shaanxi Provincial People' Hospital

    Xi'an, Shaanxi 710068
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

  • Xian Gaoxin Hospital

    Xi'an, Shaanxi 710075
    China

    Active - Recruiting

  • Xianyang Hospital of Yan'an University

    Xianyang City,, Shaanxi 716099
    China

    Active - Recruiting

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining City, Shandong 272000
    China

    Active - Recruiting

  • Liaocheng people's Hospital

    Liaocheng, Shandong 252000
    China

    Active - Recruiting

  • Qingdao Central Hospital

    Qingdao, Shandong 266042
    China

    Active - Recruiting

  • People's Hospital of Rizhao

    Rizhao City, Shandong 276800
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi 046000
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan Sheng 650032
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • Ruian People's Hospital

    Rui'an, Zhejiang 325200
    China

    Active - Recruiting

  • The First Affiliated Hosptial of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, 100044
    China

    Active - Recruiting

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053
    China

    Active - Recruiting

  • Chongqing University Three Gorges Hospital

    Chongqing, 404000
    China

    Active - Recruiting

  • The fourth people's hospital of chongqing

    Chongqing,
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, 200120
    China

    Active - Recruiting

  • Tianjin Union Medical Center

    Tianjin, 300000
    China

    Active - Recruiting

  • Seoul National University Bundang Hospital

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

    Active - Recruiting

  • Inje University - Ilsan Paik Hospital

    Goyang-si, Kyǒnggi-do 10380
    Korea, Republic of

    Active - Recruiting

  • Hallym University Dongtan Sacred Heart Hospital

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

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • Uijeongbu St. Mary's Hospital

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

    Active - Recruiting

  • Dong-A University Hospital

    Busan, Pusan-kwangyǒkshi 49201
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

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

    Active - Recruiting

  • Ewha Womans University Seoul Hospital

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

    Active - Recruiting

  • Nowon Eulji Medical Center, Eulji University

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

    Active - Recruiting

  • Seoul National University Hospital

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

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

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

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Active - Recruiting

  • Tri-Service General Hospital

    Taipei City, Taipei 114
    Taiwan

    Site Not Available

  • Chiayi Christian Hospital

    Chiayi, 600
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Tri-Service General Hospital

    Taipei, 114
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Active - Recruiting

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