202
Participants
Start Date
May 29, 2023
Primary Completion Date
September 16, 2024
Study Completion Date
December 9, 2024
Xanomeline and Trospium Chloride Capsules
Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-35 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability.
Placebo
Placebo Capsules
Beijing Anding Hospital Capital Medical University, Beijing
Peking University Sixth Hospital, Beijing
Beijing HuiLongGuan Hospital, Changping
Daqing City Third Hospital, Daqing
Shanghai Mental Health Center, Shanghai
Wuxi Mental Health Center, Wuxi
Anhui Mental Health Center, Hefei
Wuhu Hospital of Beijing Anding Hospital, Wuhu
Shandong Mental Health Center, Jinan
Shandong Daizhuang Hospital, Jining
Tianjin Anding Hospital, Tianjin
Hangzhou Seventh People's Hospital, Hangzhou
HuZhou Third Municipal Hospital, Huzhou
Ningbo Kangning Hospital, Ningbo
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou
Jiangxi Mental Health Center, Nanchang
Chongqing 11th People's Hospital, Chongqing
Chongqing Mental Health Center, Jiangbei
The Second Xiangya Hospital of Central South University, Changsha
Wuhan Mental Health Center, Wuhan
Renmin Hospital of Wuhan University, Wuhan
Zhumadian Second People's Hospital, Zhumadian
The Affiliated Brain Hospital of Guangzhou Medical University, Guanzhou
The Fourth People's Hospital of Chengdu, Chengdu
Guangyuan Mental Health Center, Guangyuan
Mental Health Center of Xi'an City, Xi'an
Urumqi Fourth People's Hospital, Ürümqi
The Sixth People's Hosptial of Hebei Province, Baoding
Lead Sponsor
Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
Karuna Therapeutics
INDUSTRY