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

Part of paid clinical trials in Bellflower, California.

Sponsor
Collaborative Neuroscience Research, LLC
Study ID
NCT06924255
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Schizophrenia Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Xanomeline and Trospium Chloride — DRUG
    accelerated titration of Xanomeline and Trospium Chloride
  • Xanomeline and Trospium Chloride — DRUG
    slow titration of Xanomeline and Trospium Chloride

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: accelerated transition
    accelerated transition arm will reduce the atypical AP treatment at a rate of 50% of the initial treatment over a 2-week period,
  • Other: slower transition
    slower transition arm will reduce the atypical AP treatment at a rate of 25% of the initial treatment over a 4-week period

Primary Outcome Measure

discontinuation rate of accelerated and slower switching of atypical antipsychotic (AP) treatment to xanomeline and trospium chloride (X/T) [ Time Frame: 8 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
CenExel CIT LABellflowerCalifornia90706
866-478-8391
Gerald Maguire, M.D. (SUB_INVESTIGATOR)
CenExel CNS - Garden GroveGarden GroveCalifornia92845
844-562-3232
David Walling, Ph.D. (PRINCIPAL_INVESTIGATOR)
CenExel CIT IERiversideCalifornia92506
866-478-8391
Evagelos Coskinas, M.D. (SUB_INVESTIGATOR)
CenExel CNS - TorranceTorranceCalifornia90504-
CenExel RCAHollywoodFlorida33024
954-919-7723
Edwin Gomez, M.D. (SUB_INVESTIGATOR)
CenExel CBHGaithersburgMaryland20877
301-251-4702
Elia Acevedo-Diaz, M.D. (SUB_INVESTIGATOR)
CenExel HRI MarltonMarltonNew Jersey08053-

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