252
Participants
Start Date
December 16, 2020
Primary Completion Date
May 24, 2022
Study Completion Date
May 24, 2022
Xanomeline and Trospium Chloride Capsules
Oral xanomeline 50 mg/trospium chloride 20 mg BID (twice a day) for the first 2 days (Days 1 and 2) followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). At Visit 5 (Day 8), dosing was to be titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the subject was continuing to experience adverse events (AEs) from the previous dose of KarXT 100/20 BID. All subjects who were increased to KarXT 125/30 BID, depending on clinical response and tolerability, had the option to return to KarXT 100/20 BID for the remainder of the treatment period.
Placebo
Placebo Capsules twice a day (BID)
iResearch Atlanta, LLC, Decatur
Innovative Clinical Research, Inc., Miami Lakes
Research Centers of America, Oakland Park
Neuro-Behavioral Clinical Research, North Canton
Uptown Research Institute, Chicago
Pillar Clinical Research, Lincolnwood
Arch Clinical Trials, St Louis
Woodland International Research Group, LLC, Little Rock
Pillar Clinical Research, Richardson
Community Clinical Research, Austin
Altea Research Institute, Las Vegas
ProScience Research Institute, Culver City
California Neuropsychopharmacology Clinical Research Institute, Pico Rivera
CITrials, Bellflower
CNS Network, Long Beach
California Clinical Trials 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
NRC Research Institute, Orange
Hassman Research Institute, Marlton
Lead Sponsor
Karuna Therapeutics
INDUSTRY