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
Collaborative Neuroscience Research, LLC
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.
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…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant is aged 18 to 65 years, inclusive, at Screening. 2. Participant is capable of providing informed consent. 1. A signed informed consent form (ICF) must be provided before any study assessments are performed. 2. Participant must be fluent in English (oral and written) as the language of the ICF to consent. No translations will be permitted. 3. Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychi…
Interventions
- DrugXanomeline and Trospium Chloride
accelerated titration of Xanomeline and Trospium Chloride
- DrugXanomeline and Trospium Chloride
slow titration of Xanomeline and Trospium Chloride
Locations (7)
- CenExel CIT LABellflower, California
- CenExel CNS - Garden GroveGarden Grove, California
- CenExel CIT IERiverside, California
- CenExel CNS - TorranceTorrance, California
- CenExel RCAHollywood, Florida
- CenExel CBHGaithersburg, Maryland