Clinical trial NCT05989048: A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 1414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with pain freedom at 2 hours post dose.
timeFrame: 2 hours post dose
measure: Percentage of participants with an MBS (most bothersome symptom) reported before dosing that is absent at 2 hours post dose.
timeFrame: 2 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second People's hospital of Hefei
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: The First Medical Center of Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Wuhan
country: China
facility: Renmin Hospital Of Wuhan University
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Wuhan Third Hospital
state: Hubei
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Lianyungang
country: China
facility: The Second People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi City
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Zhenjiang City
country: China
facility: The Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical Hospital
state: NING XIA Province
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia Province
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People' Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xian Gaoxin Hospital
state: Shaanxi
city: Xianyang City
country: China
facility: Xianyang Hospital of Yan'an University
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jining City
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng people's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Rizhao City
country: China
facility: People's Hospital of Rizhao
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan Sheng
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Rui'an
country: China
facility: Ruian People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hosptial of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
city: Chongqing
country: China
facility: The fourth people's hospital of chongqing
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Tianjin
country: China
facility: Tianjin Union Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Inje University - Ilsan Paik Hospital
state: Kyǒnggi-do
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Uijeongbu-si
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Pusan-kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Chiayi
country: Taiwan
facility: Chiayi Christian Hospital
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: