566
Participants
Start Date
June 2, 2021
Primary Completion Date
May 24, 2024
Study Completion Date
May 24, 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 8-364 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. 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.
INSPIRA Clinical Research, San Juan
Local Institution - 011-256, New York
Manhattan Behavioral Medicine, PLLC, New York
Local Institution - 011-210, New York
The Medical Research Network, LLC, New York
Finger Lakes Clinical Research, Rochester
Local Institution - 011-250, Rochester
Global Medical Institutes LLC Scranton Medical Institute, Moosic
Suburban Research Associates, Media
Local Institution - 011-207, West Chester
CBH Health, LLC, Gaithersburg
Local Institution - 011-211, Gaithersburg
Clinical Trials of America, Hickory
Local Institution - 011-259, Atlanta
Synexus Clinical Research US, Inc., Atlanta
Atlanta Center for Medical Research, Atlanta
Local Institution - 011-237, Atlanta
Local Institution - 011-224, Hallandale
Velocity Clinical Research, Hallandale Beach, Hallandale
Innovative Clinical Research, Miami Lakes
Local Institution - 011-234, Miami Lakes
Local Institution - 011-261, Hollywood
Local Institution - 011-219, Pembroke Pines
Pines Care Research Center, Pembroke Pines
Homestead Research Institute, Inc., Homestead
Local Institution - 011-231, Homestead
Premier Clinical Research Institute, Miami
Central Miami Medical Institute, Miami
Local Institution - 011-215, Miami
Local Institution - 011-220, Miami
Phoenix Medical Research, Miami
Research Centers of America at Fort Lauderdale Behavioral Health Center, Oakland Park
Local Institution - 011-262, West Palm Beach
Neuroscience Research Institute, West Palm Beach
Health Synergy Clinical Research, Okeechobee
Local Institution - 011-216, Okeechobee
Psychiatric Consultants, Franklin
Local Institution - 011-226, Flowood
Precise Research Centers, Flowood
Local Institution - 011-248, North Canton
Neuro-Behavioral Clinical Research, Inc, North Canton
Cincy Science, West Chester
Local Institution - 011-221, West Chester
Local Institution - 011-218, Dayton
Midwest Clinical Research Center, Dayton
Michigan Clinical Research Institute PC, Ann Arbor
Uptown Research Institute, Chicago
Arch Clinical Trials, St Louis
Local Institution - 011-241, St Louis
Local Institution - 011-227, Saint Charles
Midwest Research Group - St. Charles Psychiatric Associates, Saint Charles
St. Charles Psychiatric Associates/Midwest Research Group, Saint Charles
Ascension Via Christi Research, Wichita
Local Institution - 011-205, Shreveport
Louisiana Clinical Research, Shreveport
Woodland International Research Group, Little Rock
Local Institution - 011-201, Rogers
Woodland Research Northwest, Rogers
SP Research PLLC, Oklahoma City
InSite Clinical Research, LLC, DeSoto
Local Institution - 011-236, DeSoto
Local Institution - 011-258, Fort Worth
Core Clinical Research, Richmond
healthTx, Richmond
Community Clinical Research, Austin
Local Institution - 011-243, Austin
BioBehavioral Research of Austin P.C., Austin
BioBehavioral Research of Austin, Austin
Cedar Clinical Research, Draper
Altea Research Institute, Las Vegas
Local Institution - 011-239, Las Vegas
Local Institution - 011-206, Culver City
ProScience Research Group, Culver City
Collaborative Neuroscience Research, Torrance
Local Institution - 011-252, Torrance
Omega Clinical Trials, La Habra
CNRI-Los Angeles, LLC, Pico Rivera
Local Institution - 011-244, Pico Rivera
Local Institution - 011-257, Cerritos
Clinical Innovations, Inc, Bellflower
Local Institution - 011-222, Bellflower
Local Institution - 011-263, Bellflower
Alliance for Wellness dba Alliance for Research, Long Beach
Alliance for Wellness, Long Beach
Behavioral Clinical Research, Inc., Glendale
Schuster Medical Research Institute, Sherman Oaks
North County Clinical Research (NCCR), Oceanside
Excell Research Inc, Oceanside
Local Institution - 011-229, Oceanside
CITrials, Riverside
Local Institution - 011-233, Riverside
ATP Clinical Research Inc, Costa Mesa
ATP Clinical Research, Inc., Costa Mesa
CITrials, Santa Ana
Advanced Research Center, Inc., Anaheim
Local Institution - 011-253, Garden Grove
Local Institution - 011-242, Orange
NRC Research Institute, Orange
Siyan Clinical Research, Santa Rosa
Northwest Clinical Research Center, Bellevue
Local Institution - 011-260, Everett
Local Institution - 011-238, Little Rock
Local Institution - 011-240, Anaheim
Local Institution - 011-202, Glendale
Omega Clinical Trials, La Habra
Local Institution - 011-251, Santa Rosa
Local Institution - 011-246, Sherman Oaks
Local Institution - 011-203, Miami
Local Institution - 011-235, Decatur
Local Institution - 011-204, Chicago
Local Institution - 011-223, Wichita
Local Institution - 011-232, Ann Arbor
Hassman Research Institute, Berlin
Local Institution - 011-230, Berlin
Hassman Research Institute, Marlton
Local Institution - 011-249, Marlton
Local Institution - 011-209, Bellevue
Lead Sponsor
Karuna Therapeutics
INDUSTRY