drugset / Trial / NCT05145413
A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. The primary objective of the study is to assess the efficacy of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) versus placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.
Timeline
- Start
- 2021-11-12
- Primary completion
- 2025-03-19
- Completion
- 2025-03-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trospium | Small molecule | 20 mg | — |
| Subject | Trospium | Small molecule | 30 mg | — |
| Subject | Xanomeline | Small molecule | 50 mg | — |
| Subject | Xanomeline | Small molecule | 75 mg | — |
| Subject | Xanomeline | Small molecule | 100 mg | — |
| Subject | Xanomeline | Small molecule | 125 mg | — |