A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults
- Registration Number
- NCT05989048
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1238
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Zavegepant Zavegepant Zavegepant intranasal 10 mg
- Primary Outcome Measures
Name Time Method Percentage of participants with pain freedom at 2 hours post dose. 2 hours post dose To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from pain.
Percentage of participants with an MBS (most bothersome symptom) reported before dosing that is absent at 2 hours post dose. 2 hours post dose To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from MBS.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
Chang Gung Medical Foundation-Linkou Branch
π¨π³Taoyuan, Taiwan
Liaocheng people's Hospital
π¨π³Liaocheng, Shandong, China
The Second People's hospital of Hefei
π¨π³Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
π¨π³Beijing, Beijing, China
The First Medical Center of Chinese PLA General Hospital
π¨π³Beijing, Beijing, China
Chinese PLA General Hospital
π¨π³Haidian District, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
π¨π³Chongqing, Chongqing, China
Hainan General Hospital
π¨π³Haikou, Hainan, China
Renmin Hospital Of Wuhan University
π¨π³Wuhan, Hebei, China
The First Affiliated Hospital of Henan University of Science &Technology
π¨π³Luoyang, Henan, China
People's Hospital of Zhengzhou
π¨π³Zhengzhou, Henan, China
Wuhan Third Hospital
π¨π³Wuhan, Hubei, China
Changsha Central Hospital
π¨π³Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
π¨π³Changsha, Hunan, China
The Second People's Hospital of Lianyungang
π¨π³Lianyungang, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
π¨π³Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
π¨π³Suzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University
π¨π³Wuxi City,, Jiangsu, China
Wuxi People's Hospital
π¨π³Wuxi, Jiangsu, China
The Affiliated Hospital of Jiangsu University
π¨π³Zhenjiang City, Jiangsu, China
Pingxiang People's Hospital
π¨π³Pingxiang, Jiangxi, China
The First Hospital of Jilin University
π¨π³Changchun, Jilin, China
The People's Hospital of Liaoning Province
π¨π³Shenyang, Liaoning, China
General Hospital of Ningxia Medical Hospital
π¨π³Yinchuan, NING XIA Province, China
The First People's Hospital of Yinchuan
π¨π³Yinchuan, Ningxia Province, China
The First Affiliated Hospital of Xi'an Jiaotong University
π¨π³Xi'an, Shaanxi, China
Shaanxi Provincial People' Hospital
π¨π³Xi'an, Shaanxi, China
Xian Gaoxin Hospital
π¨π³Xi'an, Shaanxi, China
Xianyang Hospital of Yan'an University
π¨π³Xianyang City,, Shaanxi, China
Jinan Central Hospital
π¨π³Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
π¨π³Jining City, Shandong, China
Qingdao Central Hospital
π¨π³Qingdao, Shandong, China
People's Hospital of Rizhao
π¨π³Rizhao City, Shandong, China
Huashan Hospital, Fudan University
π¨π³Shanghai, Shanghai, China
Heping Hospital Affiliated to Changzhi Medical College
π¨π³Changzhi, Shanxi, China
First Affiliated Hospital of Kunming Medical University
π¨π³Kunming, Yunnan Sheng, China
Qilu Hospital of Shandong University
π¨π³Jinan, Shandong, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
π¨π³Hangzhou, Zhejiang, China
Ruian People's Hospital
π¨π³Rui'an, Zhejiang, China
The First Affiliated Hosptial of Wenzhou Medical University
π¨π³Wenzhou, Zhejiang, China
Peking University People's Hospital
π¨π³Beijing, China
Xuanwu Hospital Capital Medical University
π¨π³Beijing, China
Chongqing University Three Gorges Hospital
π¨π³Chongqing, China
The fourth people's hospital of chongqing
π¨π³Chongqing, China
Shanghai East Hospital
π¨π³Shanghai, China
Tianjin Union Medical Center
π¨π³Tianjin, China
Seoul National University Bundang Hospital
π°π·Seongnam, KyΗnggi-do, Korea, Republic of
Inje University - Ilsan Paik Hospital
π°π·Goyang-si, KyΗnggi-do, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
π°π·Hwaseong-si, KyΗnggi-do, Korea, Republic of
Uijeongbu St. Mary's Hospital
π°π·Uijeongbu-si, KyΗnggi-do, Korea, Republic of
Taipei Veterans General Hospital
π¨π³Taipei, Taiwan
Dong-A University Hospital
π°π·Busan, Pusan-kwangyΗkshi, Korea, Republic of
Nowon Eulji Medical Center, Eulji University
π°π·Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Seoul National University Hospital
π°π·Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System
π°π·Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Asan Medical Center
π°π·Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Ewha Womans University Seoul Hospital
π°π·Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Kangbuk Samsung Hospital
π°π·Seoul, Korea, Republic of
Tri-Service General Hospital
π¨π³Taipei, Taiwan
Chiayi Christian Hospital
π¨π³Chiayi, Taiwan