A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia

PHASE2CompletedINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

September 18, 2018

Primary Completion Date

September 4, 2019

Study Completion Date

September 4, 2019

Conditions
Schizophrenia
Interventions
DRUG

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.

DRUG

Placebo Capsules

Placebo Capsules

Trial Locations (12)

20877

CBH Health, LLC, Gaithersburg

30331

Atlanta Center for Medical Research, Atlanta

45417

Midwest Clinical Research Center (and IP Shipment), Dayton

72211

Woodland International Research Group, LLC, Little Rock

75080

Pillar Clinical Research, LLC, Richardson

75115

InSite Clinical Research, LLC, DeSoto

78754

Community Clinical Research, Inc., Austin

90806

Collaborative Neuroscience Network, LLC., Long Beach

91945

Synergy East, Lemon Grove

92103

Artemis Institute for Clinical Research, San Diego

92868

NRC Research Institute, Orange

08009

Hassman Research Institute, Berlin

Sponsors
All Listed Sponsors
lead

Karuna Therapeutics

INDUSTRY

NCT03697252 - A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia | Biotech Hunter | Biotech Hunter