NCT06924255

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

An 8-week Open-label, Multicenter Randomized Study of Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment to Assess the Safety, Tolerability, and Efficacy in Participants With DSM-5 Schizophrenia

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Collaborative Neuroscience Research, LLC · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be a 2-arm, multicenter, randomized, 8-week, open-label study to evaluate the safety and tolerability, as well as the efficacy, of transition in adult participants with schizophrenia in an outpatient setting from oral atypical AP treatment to X/T. The study design is a de-escalation of current oral atypical AP therapy to a X/T via accelerated or slower transition from current treatment. The study will consist of a Screening Phase of up to 14 days, a Pre-switch Baseline Visit, an 8 week open-label Treatment Phase, and a safety Follow-up/End of Study (EOS) Visit at 7+2 days following the last dose of X/T for participants who complete the Treatment Phase and those who prematurely discontinue from the study. Participants who prematurely discontinue from the study due to AEs or lack of efficacy will be encouraged to continue with study procedures even though they are no longer receiving study drug.

Conditions

• Schizophrenia Disorders

Interventions

Type	Name	Description
DRUG	Xanomeline and Trospium Chloride	accelerated titration of Xanomeline and Trospium Chloride
DRUG	Xanomeline and Trospium Chloride	slow titration of Xanomeline and Trospium Chloride

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-04-11
• Last updated: 2025-04-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study