drugset / Trial / NCT06924255
An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia
Phase 4
Not yet recruiting
100 enrolled
Collaborative Neuroscience Research, LLC
Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study design is a de-escalation of current atypical AP treatment to X/T at a maintenance dose of X/T established either at 100 mg xanomeline/20 mg trospium chloride BID (total daily dose 200 mg xanomeline/40 mg trospium chloride) or 125 mg xanomeline/30 mg trospium chloride BID (total daily dose 250 mg xanomeline/60 mg trospium chloride) based on participants' clinical response and/or tolerability. While the package insert for X/T provides guidance for clinicians on dosing, this study is designed to assess how transitioning will occur in the "real world" situation.
Timeline
- Start
- 2025-04
- Primary completion
- 2025-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trospium | Small molecule | 20 mg | — |
| Subject | Trospium | Small molecule | 30 mg | — |
| Subject | Xanomeline | Small molecule | 100 mg | — |
| Subject | Xanomeline | Small molecule | 125 mg | — |