Clinical Trial

An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia

Not Yet Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated April 11, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06924255
Lead Sponsor Collaborative Neuroscience Research, LLC
Collaborators: Bristol-Myers Squibb
Conditions Schizophrenia Disorders
Enrollment 100 participants
Start Date 2025-04
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-11