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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989048
• Other study ID #: C5301008
• Status: Recruiting
• Phase: Phase 3
• Start date: November 29, 2023
• Est. completion date: July 19, 2025

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: July 19, 2025
• Est. primary completion date: June 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

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

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

5. 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).

6. 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).

7. 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.

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

Exclusion 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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Zavegepant
The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.
• Placebo
Single dose of matching placebo taken within Treatment Phase.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking University People's Hospital	Beijing
China	The First Medical Center of Chinese PLA General Hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	Changsha Central Hospital	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Heping Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi
China	Chongqing University Three Gorges Hospital	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The fourth people's hospital of chongqing	Chongqing
China	Chinese PLA General Hospital	Haidian District	Beijing
China	Hainan General Hospital	Haikou	Hainan
China	The Second People's hospital of Hefei	Hefei	Anhui
China	Jinan Central Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Affiliated Hospital of Jining Medical University	Jining City	Shandong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan Sheng
China	The Second People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	The Second People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	Liaocheng people's Hospital	Liaocheng	Shandong
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Qingdao Central Hospital	Qingdao	Shandong
China	People's Hospital of Rizhao	Rizhao City	Shandong
China	Ruian People's Hospital	Rui'an	Zhejiang
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Tianjin Union Medical Center	Tianjin
China	The First Affiliated Hosptial of Wenzhou Medical University	Wenzhou	Zhejiang
China	Renmin Hospital Of Wuhan University	Wuhan	Hebei
China	Wuhan Third Hospital	Wuhan	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Affiliated Hospital of Jiangnan University	Wuxi City,	Jiangsu
China	Shaanxi Provincial People' Hospital	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xian Gaoxin Hospital	Xi'an	Shaanxi
China	Xianyang Hospital of Yan'an University	Xianyang City,	Shaanxi
China	General Hospital of Ningxia Medical Hospital	Yinchuan	NING XIA Province
China	The First People's Hospital of Yinchuan	Yinchuan	Ningxia Province
China	People's Hospital of Zhengzhou	Zhengzhou	Henan
China	The Affiliated Hospital of Jiangsu University	Zhenjiang City	Jiangsu
Korea, Republic of	Dong-A University Hospital	Busan	Pusan-kwangyokshi
Korea, Republic of	Inje University - Ilsan Paik Hospital	Goyang-si	Kyonggi-do
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si	Kyonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Ewha Womans University Seoul Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu-si	Kyonggi-do
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei City	Taipei
Taiwan	Tri-Service General Hospital	Taipei City
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   To obtain contact information for a study center near you, click here.