256
Participants
Start Date
April 6, 2021
Primary Completion Date
November 29, 2022
Study Completion Date
December 7, 2022
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
Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Smila
M.I. Pyrogov Vinnytsya National Medical University, Vinnytsia
iResearch Atlanta, LLC, Decatur
Atlanta Center for Medical Research, Atlanta
Behavioral Clinical Research, Inc., Hollywood
Larkin Behavioral Health Services, Hollywood
Regional Institution of Mental Psychiatric Care of the Poltava Regional Council, Poltava
Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov, Dnipro
AMITA Health Center for Psychiatric Research, Hoffman Estates
AMITA Health Center for Psychiatric Research, Chicago
Uptown Research Institute, Chicago
Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Kharkiv
Regional Clinical Psychiatric Hospital No. 3, Adult Psychiatric Department No. 3, Kharkiv
Regional Clinical Psychiatric Hospital No. 3, Psychiatric Department for First Episode Psychosis, Kharkiv
Woodland International Research Group, Little Rock
Pillar Clinical Research, Bentonville
Kherson Regional Institution of Mental Care, Kherson
InSite Clinical Research, LLC, DeSoto
Community Clinical Research, Inc., Austin
Lviv Regional Clinical Psychiatric Hospital, Department #20, Lviv
Lviv Regional Clinical Psychiatric Hospital, Department #25, Lviv
ProScience Research Group, Culver City
Clinical Innovations, Inc, Bellflower
CNS Network, Long Beach
Artemis Institute for Clinical Research, San Diego
Advanced Research Center, Inc., Anaheim
Collaborative Neuroscience Research, LLC., Garden Grove
NRC Research Institute, Orange
Hassman Research Institute, Berlin
Hassman Research Institute, Marlton
Kyiv City Psychoneurological Hospital #2, Kyiv
"Kyiv Regional Medical Incorporation Psychiatry, Center for Novel Treatment and Rehabilitation of Psychotic Disorders", Kyiv
Lead Sponsor
Karuna Therapeutics
INDUSTRY