A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
Status:
Completed
Trial end date:
2019-09-04
Target enrollment:
Participant gender:
Summary
This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine
the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with
DSM-5 schizophrenia who are in an acute exacerbation phase. The primary objective of the
study is to assess the efficacy of KarXT (a fixed combination of xanomeline and trospium
chloride) (xanomeline 125 mg/trospium 30 mg twice daily [BID]) versus placebo in reducing
Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a
Diagnostic and Statistical Manual-Fifth Edition (DSM-5) diagnosis of schizophrenia. The
secondary objectives of the study are to assess overall safety and tolerability of KarXT in
adult inpatients with a DSM-5 diagnosis of schizophrenia.