152
Participants
Start Date
February 1, 2021
Primary Completion Date
October 3, 2023
Study Completion Date
October 3, 2023
Xanomeline and Trospium Chloride Capsules
Oral xanomeline 50 mg/trospium chloride 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium chloride 20 mg BID on days 3-7. The dosage is increased to xanomeline 125 mg/trospium chloride 30 mg BID on days 8-364 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium chloride 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium chloride 30 mg will have the option to return to xanomeline 100 mg/ trospium chloride 20 mg depending on clinical response and tolerability. Re-escalation to 125/30 BID or re-titration in cases in which the subject has been off KarXT for a longer period of time (at least a week) is allowed and will require a discussion between the principal investigator and the medical monitor.
Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12, Smila
M.I. Pyrogov Vinnytsya National Medical University, Vinnytsia
iResearch Atlanta, LLC, Decatur
Atlanta Center for Medical Research, Atlanta
Innovative Clinical Research, Inc., Miami Lakes
Behavioral Clinical Research, Inc., Hollywood
Research Centers of America, Hollywood
Regional Facility for Psychiatric Care of Poltava Regional Council, 2-A acute general psychiatric male ward, 5-B acute, quiet, general psychiatric female ward, Poltava State Medical University, Academic Department of Psychiatry, Addictology and Medical, Poltava
Neuro-Behavioral Clinical Research, Inc., North Canton
Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov, Dnipro
AMITA Health Center for Psychiatric Research, Hoffman Estates
Mitchell L. Glaser, Chicago
Uptown Research Institute, Chicago
Pillar Clinical Research, Lincolnwood
Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Kharkiv
Arch Clinical Trials, St Louis
Woodland International Research Group, Little Rock
Pillar Clinical Research, Bentonville
Kherson Regional Insititution of Mental Care of Kherson Regional Council Male Psychiatric Department #3, Femail Psychiatric Department #10, Kherson
Pillar Clinical Research, LLC, Richardson
InSite Clinical Research, DeSoto
Community Clinical Research, Austin
Lviv Regional Clinical Psychiatric Hospital, Department #20, Lviv
Lviv Regional Clinical Psychiatric Hospital, Department #25, Lviv
Altea Research Institute, Las Vegas
Proscience Research Group, Culver City
Collaborative Neuroscience Research, LLC., Torrance
California Neuropsychopharmacology Clinical Research Institute, Pico Rivera
Advanced Research Center Inc, Bellflower
CITrials, Bellflower
CNS Network, Long Beach
California Clinical Trial Medical Group, Glendale
Schuster Medical Research Institute, Sherman Oaks
Catalina Research Institute, LLC, Montclair
Synergy San Diego, Lemon Grove
California Neuropsychopharmacology Clinical Research Institute, San Diego
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
Regional Clinical Psychiatric Hospital No. 3, Adult Psychiatric Department No. 3, Kharkiv
"Kyiv Regional Medical Incorporation Psychiatry, Center for Novel Treatment and Rehabilitation of Psychotic Disorders", Kyiv
Lead Sponsor
Karuna Therapeutics
INDUSTRY