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drugset / Trial / NCT05919823

A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia

NCT05919823 ↗

Phase 3 Completed 202 enrolled Karuna Therapeutics, Inc. Zai Lab (Shanghai) Co., Ltd. · collab
RandomizedFactorialTriple-blindTreatment

Summary

A Phase 3, Multicenter, Two-part Study with a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects with DSM-5 Schizophrenia

Timeline

Start
2023-05-29
Primary completion
2024-09-16
Completion
2024-12-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Trospium Small molecule 20 mg Oral
Subject Trospium Small molecule 30 mg Oral
Subject Xanomeline Small molecule 100 mg Oral
Subject Xanomeline Small molecule 125 mg Oral

Indications

schizophrenia