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
Sites (59)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Medical Center of Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Changsha Central Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Heping Hospital Affiliated to Changzhi Medical College Coordinator of this site? Confirm its status | Changzhi | China | Unknown status |
| The fourth people's hospital of chongqing Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing University Three Gorges Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Hainan General Hospital Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second People's Hospital of Hefei Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Affiliated Hospital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| The Second People's Hospital of Lianyungang Coordinator of this site? Confirm its status | Lianyungang | China | Unknown status |
| Liaocheng People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science &Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| Qingdao Central Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| People's Hospital of Rizhao Coordinator of this site? Confirm its status | Rizhao | China | Unknown status |
| Ruian People's Hospital Coordinator of this site? Confirm its status | Rui’an | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The People's Hospital of Liaoning Province Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Union Medical Center Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hosptial of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuhan Third Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuxi People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Affiliated Hospital of Jiangnan University Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Shaanxi Provincial People' Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Xian Gaoxin Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Xianyang Hospital of Yan'an University Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| The First People's Hospital of Yinchuan Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| General Hospital of Ningxia Medical Hospital Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| People's Hospital of Zhengzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Dong-A University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Inje University Ilsan Paik Hospital Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Hallym University Dongtan Sacred Heart Hospital Coordinator of this site? Confirm its status | Hwaseong-si | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Ewha Womans University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Nowon Eulji Medical Center, Eulji University Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Uijeongbu St. Mary's Hospital Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.