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NCT05989048CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1414 (actual)
First submitted
3 Aug 2023
Start date
29 Nov 2023
Primary completion date
30 May 2025
Lead sponsor
Pfizer
Diseases
Migraine
NCT number
NCT05989048

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1414
  • From 29 Nov 2023 to the primary completion date, 30 May 2025
  • 59 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Medication overuse headaches.

Other illness

  • 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.

Who the study is looking for

  • 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:
    • Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
    • Migraine attacks, on average, lasting about 4-72 hours if untreated.
    • Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months.
    • Participants must be able to distinguish migraine attacks from tension/cluster headaches.
    • 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).
    • 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).
    • 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.
    • Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (59)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Xuanwu Hospital, Capital Medical University
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BeijingChinaUnknown status
The First Medical Center of Chinese PLA General Hospital
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Changsha Central Hospital
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ChangshaChinaUnknown status
The Third Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Heping Hospital Affiliated to Changzhi Medical College
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ChangzhiChinaUnknown status
The fourth people's hospital of chongqing
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ChongqingChinaUnknown status
Chongqing University Three Gorges Hospital
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ChongqingChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Hainan General Hospital
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HaikouChinaUnknown status
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The Second People's Hospital of Hefei
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HefeiChinaUnknown status
Qilu Hospital of Shandong University
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JinanChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Affiliated Hospital of Jining Medical University
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JiningChinaUnknown status
First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
The Second People's Hospital of Lianyungang
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LianyungangChinaUnknown status
Liaocheng People's Hospital
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LiaochengChinaUnknown status
The First Affiliated Hospital of Henan University of Science &Technology
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LuoyangChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaUnknown status
Pingxiang People's Hospital
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PingxiangChinaUnknown status
Qingdao Central Hospital
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QingdaoChinaUnknown status
People's Hospital of Rizhao
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RizhaoChinaUnknown status
Ruian People's Hospital
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Rui’anChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
Shanghai East Hospital
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ShanghaiChinaUnknown status
The People's Hospital of Liaoning Province
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ShenyangChinaUnknown status
The Second Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
Tianjin Union Medical Center
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TianjinChinaUnknown status
The First Affiliated Hosptial of Wenzhou Medical University
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WenzhouChinaUnknown status
Renmin Hospital of Wuhan University
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WuhanChinaUnknown status
Wuhan Third Hospital
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WuhanChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
Affiliated Hospital of Jiangnan University
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WuxiChinaUnknown status
Shaanxi Provincial People' Hospital
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Xi'anChinaUnknown status
Xian Gaoxin Hospital
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Xi'anChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Xianyang Hospital of Yan'an University
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XianyangChinaUnknown status
The First People's Hospital of Yinchuan
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YinchuanChinaUnknown status
General Hospital of Ningxia Medical Hospital
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YinchuanChinaUnknown status
People's Hospital of Zhengzhou
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ZhengzhouChinaUnknown status
The Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status
Dong-A University Hospital
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BusanSouth KoreaUnknown status
Inje University Ilsan Paik Hospital
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Goyang-siSouth KoreaUnknown status
Hallym University Dongtan Sacred Heart Hospital
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Hwaseong-siSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Ewha Womans University Seoul Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Nowon Eulji Medical Center, Eulji University
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Uijeongbu St. Mary's Hospital
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Uijeongbu-siSouth KoreaUnknown status
Tri-Service General Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.