Schizophrenia DisordersPhase 4NCT06924255
An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia
A Phase 4 study testing Xanomeline and Trospium Chloride in people with Schizophrenia Disorders, run by Collaborative Neuroscience Research, LLC at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Disorders
- What is being tested?
- Xanomeline and Trospium Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2025to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is aged 18 to 65 years, inclusive, at Screening.
- Participant is capable of providing informed consent.
- A signed informed consent form (ICF) must be provided before any study assessments are performed.
- Participant must be fluent in English (oral and written) as the language of the ICF to consent. No translations will be permitted.
- 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 Psychiatric Association 2013) criteria and confirmed by MINI for Schizophrenia and Psychotic Disorder Studies version 7.0.2.
- Participant has not required psychiatric hospitalization, acute crisis intervention, or other increase in level of care due to symptom exacerbation within 12 weeks of Screening and is psychiatrically stable in the opinion of the Investigator.
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- PANSS Total Score of ≤80 at Screening and Baseline Visits.
- Score of ≤4 for the following core Positive Subscale items on PANSS: i. Item 2 (P2): Conceptual disorganization ii. Item 7 (P7): Hostility
- CGI-S score of ≤4 at Screening and Baseline Visits.
- Participant must be judged by the Investigator to be an appropriate candidate for transitioning from current oral AP medication due to safety or tolerability concerns and/or insufficient efficacy.
- Participant is taking an oral AP and the AP regimen has been stable for at least 6 weeks prior to Screening. Participants are permitted to remain on non-prohibited (see Section 5.2, Exclusion Criterion #14, and Section 7.8) psychotropic medications (that are not secondary AP treatments) other than the primary pre-switch AP that have been part of their ongoing treatment regimen.
- For at least 6 weeks prior to Screening, the participant must be taking a single oral atypical AP medication at a dose and frequency consistent with the drug label. Low dose quetiapine (e.g., taken for sleep) taken in the 6 week prior to Screening is not exclusionary but must be discontinued by the Baseline Visit.
- Participant must be currently treated with one of the following selected atypical oral AP at the same dosing regimen at package insert specified dose range for schizophrenia for ≥6 weeks:
- Risperidone
- Paliperidone
- Aripiprazole
- Ziprasidone
- Quetiapine
- Lurasidone
- Lumateperone
- Brexpiprazole
- Olanzapine No participants taking first-generation (typical) AP are to be included in the study.
- In the opinion of the Investigator, it is clinically appropriate for the participant to discontinue current AP therapy and initiate treatment with X/T.
- Participant is willing and able, in the opinion of the Investigator, to discontinue all secondary AP medications prior to Baseline visit.
- BMI must be ≥18 and ≤40 kg/m2.
- Participant resides in a stable living situation and is anticipated to remain in a stable living situation for the duration of study enrollment, in the opinion of the investigator.
- Individuals of childbearing potential (IOCBP) must be willing and able to adhere to the contraception guidelines as defined in Appendix 1.
Who cannot join
- Any primary DSM-5 disorder other than schizophrenia within 6 months before Screening (confirmed using MINI version 7.0.2 at Screening). Exclusionary disorders include, but are not limited to, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild mood dysphoria or anxiety are allowed as long as these symptoms are not the primary focus of treatment.
- Participant has a history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 6 months or a positive urine drug screen (UDS) for a substance other than cannabis at Screening or Baseline.
- Participants with mild substance use disorder within the 6 months before Screening must be discussed and agreed upon with the Principal Investigator (PI) before they can be allowed into the study.
- Participants with positive UDS for cannabis are permitted to enroll in the study provided that the participants' pattern of use is not indicative of a substance use disorder.
- Urine toxicology screen positive for phencyclidine, amphetamines, opiates, cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator).
- History or presence of clinically significant cardiovascular (e.g., untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal (GI, e.g., obstructive disorders [including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis], endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.
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- Participant with cirrhosis, biliary duct abnormalities, and/or hepatobiliary carcinoma based on either medical history or liver function test results.
- All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]).
- History or high risk of urinary retention or gastric retention.
- History of narrow-angle glaucoma.
- History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment. Non-suicidal self-injurious behavior is not exclusionary.
- Clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at Screening.
- An eGFR of < 60 mL/min
- Elevations in hepatic transaminases at screening ≥3× ULN for ALT and AST and/or bilirubin > 2× ULN, unless in the context of Gilbert's syndrome
- History of unstable hypertension or tachycardia as evidenced by:
- Blood pressure of ≥160/100 mmHg (single seated measure) at screening
- Heart rate of ≥110 bpm (single seated measure) at Screening
- Participant is receiving other psychotropic medications for psychiatric and neurological conditions with Anticholinergic Risk Scale (ARS) scores >1 (tricyclic antidepressants, paroxetine, antispasmodics, antihistamines with anticholinergic properties).
- History of treatment resistance to schizophrenia medications defined as:
- Failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) within the past 12 months OR
- Has a history of having received clozapine
- Participant is receiving a long-acting injectable AP.
- Developmental disorder, intellectual disability, or autism spectrum disorder (by history), with the exception of participants diagnosed with autism at age <18 due to historic diagnostic criteria precluding schizophrenia diagnoses of minors (at discretion of Investigator).
- Lifetime history of clinically significant head trauma.
- Pregnant, breastfeeding, or less than 3 months postpartum.
- Active biliary disease (e.g., symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the Medical Monitor.
- Participants with any of the following:
- History of bladder stones
- History of recurrent urinary tract infections
- For male participants, serum prostate-specific antigen >10 ng/mL at Screening
- For male participants ≥45 years of age, International Prostate Symptom Score (IPSS) of 5 (i.e., "almost always") on items 1, 3, 5, or 6
- For male participants ≥45 years of age, an IPSS ≥9 for the sum of items 1, 3, 5, and 6
- In the opinion of the Investigator (and/or Sponsor), participant is unsuitable for enrollment in the study, or participant has any finding that, in the opinion of the Investigator (and/or Sponsor), may compromise the safety of the participant or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements.
- Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 12 months before Screening.
- Participant with prior exposure to X/T or who has a history of prior X/T intolerability (allergy/hypersensitivity).
- Risk of violent or destructive behavior in the opinion of the Investigator.
- Current involuntary hospitalization or incarceration.
- Participation in another clinical study in which the participant received an experimental or investigational drug agent within 3 months prior to Screening.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
CenExel CIT LA
Bellflower, California, 90706
866-478-8391
Gerald Maguire, M.D.
CenExel CBH
Gaithersburg, Maryland, 20877
301-251-4702
Elia Acevedo-Diaz, M.D.
CenExel CNS - Garden Grove
Garden Grove, California, 92845
844-562-3232
David Walling, Ph.D.
CenExel RCA
Hollywood, Florida, 33024
954-919-7723
Edwin Gomez, M.D.
CenExel HRI Marlton
Marlton, New Jersey, 08053
CenExel CIT IE
Riverside, California, 92506
866-478-8391
Evagelos Coskinas, M.D.
CenExel CNS - Torrance
Torrance, California, 90504
About this study
Official title: 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
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.
Read the 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
- Being tested
- Xanomeline and Trospium Chloride
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanomeline and Trospium ChlorideDrug
accelerated titration of Xanomeline and Trospium Chloride
Xanomeline and Trospium ChlorideDrug
slow titration of Xanomeline and Trospium Chloride
| Study group | Role | What they receive |
|---|---|---|
| accelerated transition | Other | accelerated transition arm will reduce the atypical AP treatment at a rate of 50% of the initial treatment over a 2-week period, Receives: Drug: Xanomeline and Trospium Chloride |
| slower transition | Other | slower transition arm will reduce the atypical AP treatment at a rate of 25% of the initial treatment over a 4-week period Receives: Drug: Xanomeline and Trospium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
discontinuation rate of accelerated and slower switching of atypical antipsychotic (AP) treatment to xanomeline and trospium chloride (X/T)
To evaluate all-cause X/T discontinuation rate of accelerated and slower switching of atypical antipsychotic (AP) treatment to xanomeline and trospium chloride (X/T) over a period of 8 weeks
Measured: 8 weeks
Secondary outcomes (2)
evaluate the effectiveness of switching outpatients from standard atypical AP treatment to X/T
To evaluate the effectiveness of switching outpatients from standard atypical AP treatment to X/T over a period of 8 weeks
Measured: 8 weeks
evaluate the safety and tolerability of X/T following switch from atypical AP
To evaluate the safety and tolerability of X/T following switch from atypical AP
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collaborative Neuroscience Research, LLC
- Sponsor type
- Research network
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924255
- Sponsor's protocol ID
- CN012-0079
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deciding on what journals to submit data
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06924255
- Acronym / sponsor ID
- CN012-0079
- Conditions
- Schizophrenia Disorders
- Keywords
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Collaborative Neuroscience Research, LLCResearch network
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| accelerated transition | Other | Drug: Xanomeline and Trospium Chlorideaccelerated transition arm will reduce the atypical AP treatment at a rate of 50% of the initial treatment over a 2-week period, |
| slower transition | Other | Drug: Xanomeline and Trospium Chlorideslower transition arm will reduce the atypical AP treatment at a rate of 25% of the initial treatment over a 4-week period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Participant is aged 18 to 65 years, inclusive, at Screening.
- Participant is capable of providing informed consent.
- 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 Psychiatric Association 2013) criteria and confirmed by MINI for Schizophrenia and Psychotic Disorder Studies version 7.0.2.
- Participant has not required psychiatric hospitalization, acute crisis intervention, or other increase in level of care due to symptom exacerbation within 12 weeks of Screening and is psychiatrically stable in the opinion of the Investigator.
- PANSS Total Score of ≤80 at Screening and Baseline Visits.
Key exclusion criteria (39 listed)
- Any primary DSM-5 disorder other than schizophrenia within 6 months before Screening (confirmed using MINI version 7.0.2 at Screening). Exclusionary disorders include, but are not limited to, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild mood dysphoria or anxiety are allowed as long as these symptoms are not the primary focus of treatment.
- Participant has a history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 6 months or a positive urine drug screen (UDS) for a substance other than cannabis at Screening or Baseline.
- History or presence of clinically significant cardiovascular (e.g., untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal (GI, e.g., obstructive disorders [including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis], endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.
- Participant with cirrhosis, biliary duct abnormalities, and/or hepatobiliary carcinoma based on either medical history or liver function test results.
- All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xanomeline and Trospium Chlorideaccelerated titration of Xanomeline and Trospium Chloride | Drug | accelerated transition, slower transition |
| Xanomeline and Trospium Chlorideslow titration of Xanomeline and Trospium Chloride | Drug | accelerated transition, slower transition |
Primary outcome
discontinuation rate of accelerated and slower switching of atypical antipsychotic (AP) treatment to xanomeline and trospium chloride (X/T)
Time frame: 8 weeks
To evaluate all-cause X/T discontinuation rate of accelerated and slower switching of atypical antipsychotic (AP) treatment to xanomeline and trospium chloride (X/T) over a period of 8 weeks
2 secondary outcomes
evaluate the effectiveness of switching outpatients from standard atypical AP treatment to X/T
Time frame: 8 weeks
evaluate the safety and tolerability of X/T following switch from atypical AP
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Undecided. Deciding on what journals to submit data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xanomeline and Trospium Chloride in people with Schizophrenia Disorders, run by Collaborative Neuroscience Research, LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.