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
2 other identifiers
interventional
1,414
3 countries
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
November 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedAugust 13, 2025
August 1, 2025
1.5 years
August 3, 2023
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of participants with pain freedom at 2 hours post dose.
To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from pain.
2 hours post dose
Percentage of participants with an MBS (most bothersome symptom) reported before dosing that is absent at 2 hours post dose.
To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from MBS.
2 hours post dose
Study Arms (2)
Zavegepant
EXPERIMENTALZavegepant intranasal 10 mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (61)
The Second People's hospital of Hefei
Hefei, Anhui, 230011, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Renmin Hospital Of Wuhan University
Wuhan, Hebei, 430060, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471000, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000, China
Wuhan Third Hospital
Wuhan, Hubei, 430074, China
Changsha Central Hospital
Changsha, Hunan, 410004, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222006, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214125, China
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212008, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110016, China
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, 750001, China
General Hospital of Ningxia Medical Hospital
Yinchuan, Ningxia, 750003, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shaanxi Provincial People' Hospital
Xi'an, Shaanxi, 710068, China
Xian Gaoxin Hospital
Xi'an, Shaanxi, 710075, China
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi, 716099, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000, China
Liaocheng people's Hospital
Liaocheng, Shandong, 252000, China
Qingdao Central Hospital
Qingdao, Shandong, 266042, China
People's Hospital of Rizhao
Rizhao, Shandong, 276800, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Ruian People's Hospital
Rui’an, Zhejiang, 325200, China
The First Affiliated Hosptial of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Peking University People's Hospital
Beijing, 100044, China
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Chongqing University Three Gorges Hospital
Chongqing, 404000, China
The fourth people's hospital of chongqing
Chongqing, China
Shanghai East Hospital
Shanghai, 200120, China
Tianjin Union Medical Center
Tianjin, 300000, China
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Inje University - Ilsan Paik Hospital
Goyang-si, Kyǒnggi-do, 10380, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Kyǒnggi-do, 18450, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, Kyǒnggi-do, 11765, South Korea
Dong-A University Hospital
Busan, Pusan-kwangyǒkshi, 49201, South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, Seoul-teukbyeolsi [seoul], 01830, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea
Ewha Womans University Seoul Hospital
Seoul, Seoul-teukbyeolsi [seoul], 07804, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2023
First Posted
August 14, 2023
Study Start
November 29, 2023
Primary Completion
May 30, 2025
Study Completion
May 30, 2025
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.