182
Participants
Start Date
September 18, 2018
Primary Completion Date
September 4, 2019
Study Completion Date
September 4, 2019
Xanomeline and Trospium Chloride Capsules
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 8-34 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. Dosing must not change after Visit 7 of the study (at 21 ± 2 days of dosing) and may be decreased for tolerability reasons no more than once during the study.
Placebo Capsules
Placebo Capsules
CBH Health, LLC, Gaithersburg
Atlanta Center for Medical Research, Atlanta
Midwest Clinical Research Center (and IP Shipment), Dayton
Woodland International Research Group, LLC, Little Rock
Pillar Clinical Research, LLC, Richardson
InSite Clinical Research, LLC, DeSoto
Community Clinical Research, Inc., Austin
Collaborative Neuroscience Network, LLC., Long Beach
Synergy East, Lemon Grove
Artemis Institute for Clinical Research, San Diego
NRC Research Institute, Orange
Hassman Research Institute, Berlin
Lead Sponsor
Karuna Therapeutics
INDUSTRY