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SchizophreniaPhase 4NCT06923891

An Open-Label Study to Evaluate the Efficacy and Tolerability of Xanomeline/Trospium In First Episode/Early Phase Schizophrenia Patients

A Phase 4 study testing Xanomeline/Trospium in people with Schizophrenia, run by Vanguard Research Group at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is an open label study of the treatment satisfaction, efficacy and tolerability of xanomeline/ trospium in a population of 172 participants diagnosed with schizophrenia in the early phase of illness. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Schizophrenia
What is being tested?
Xanomeline/Trospium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteUnited States
Study dates
16 Apr 2025to 30 Nov 2026
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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participant is aged 18-40 years, inclusive, at time of signing the ICF
  • Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2.
  • Participant Scores MSQ ≤3 for the Medication Satisfaction Questionnaire (MSQ)
  • Within 5 years of first antipsychotic treatment for psychosis at time of signing ICF
  • Clinical reason to seek a change in antipsychotic treatment due to psychosis symptom severity, it is clinically appropriate for the participant to seek a change in antipsychotic treatment due to psychosis symptom severity, adverse effects, both, or overall patient judgement/choice.
  • Symptom Severity Criteria:
Show all 17Show fewer
  • Clinical reasons include Positive and Negative Syndrome Scale (PANSS) total score of ≤ 120 at screening if participant is experiencing inefficacy from current antipsychotic treatment and
  • A score of ≥ 4 (moderate or greater) for ≥ 1 of the following PANSS Positive Subscale (P) items: i. Item 1 (P1; delusions), ii. Item 2 (P2; conceptual disorganization), iii. Item 3 (P3; hallucinatory behavior), iv. Item 6 (P6; suspiciousness/persecution) and
  • A Clinical Global Impressions-Severity scale (CGI-S) score of ≥ 4 at screening and baseline visits.
  • OR
  • Adverse Event or Overall Patient Choice Criteria:
  • A score of <4 for all the following PANSS Positive Subscale (P) items: i. Item 1 (P1; delusions), ii. Item 2 (P2; conceptual disorganization), iii. Item 3 (P3; hallucinatory behavior), iv. Item 6 (P6; suspiciousness/persecution)
  • Participant Scores MSQ ≤3 for the Medication Satisfaction Questionnaire (MSQ)Clinical reason to seek a change in antipsychotic treatment due to adverse effects or overall patient judgement/choice.
  • Upon screening, the treatment plan is for outpatient level of care. Transition to inpatient level of care after enrollment does not exclude the patient from participating in the study
  • Participant is taking an antipsychotic (AP) and the AP regimen has been stable for at least 8 weeks with at least the last 4 weeks on the same dose (i.e., untreated patients or patients receiving antipsychotic polypharmacy are excluded) prior to Screening. Participants are permitted to remain on non-prohibited (see, Exclusion Criterion, and Section 9) psychotropic medications (that are not secondary AP treatments) other than the primary pre-switch AP that have been part of their ongoing treatment regimen.
  • Anticholinergic drugs (e.g., benztropine) are allowed at baseline but need to be washed out during cross titration within 1 week after initiating xanomeline/trospium.
  • Subject can provide informed consent. A signed informed consent form must be provided before any study assessments are performed. Subject must be fluent (oral and written) in English to consent. Female participants must be willing and capable to use birth control throughout the time of the trial as defined in Section 3.1.3

Who cannot join

  • Any DSM-5 disorder other than schizophrenia within 6 months before screening (confirmed using MINI version 7.0.2 at screening) requiring clinical attention.
  • Active substance or alcohol abuse or dependence in the past 6 months (cannabis use is allowed if not fulfilling abuse criteria)
  • Urine toxicology screen is positive for phencyclidine, amphetamines, opiates, cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator)
  • Developmental disorder or intellectual disability
  • History of serious suicide attempt within the past 6 months
  • Risk of suicidal behavior as determined by the Investigator's clinical assessment. Lifetime history of clinically significant head trauma, or current history of other acute or serious medical condition or
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  • History or presence of clinically significant cardiovascular (eg, 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.
  • Active biliary disease (eg, symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the medical monitor
  • History or high risk of urinary retention, gastric retention,
  • Untreated narrow-angle glaucoma
  • An estimated glomerular filtration rate (eGFR) of < 60 mL/min at the screening visit.
  • Elevations in hepatic transaminases at screening ≥ 3× ULN for ALT and AST and/or ≥ 2× ULN for total bilirubin
  • History of hypersensitivity or prior exposure to xanomeline/trospium or trospium chloride
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
  • Intellectual disability or autism spectrum disorder (by history)
  • Active substance dependence within the past 3 months (except for tobacco and cannabis)
  • Participant has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 6 weeks at an adequate dose per the label), based on TRIPP guidelines (Howes, et al 2017).
  • Participant is on or has history of clozapine treatment
  • Participant is on≥ 2 antipsychotics at baseline
  • Participant has received a long-acting injectable antipsychotic within one injection cycle for that formulation at the time of baseline (i.e., cycles are defined by the interval in which the LAI is administered. If it is a monthly administration, then the exclusion is for one month since the last LAI administration).
  • Participant is receiving other psychotropic medications other than the antipsychotic to be switched, for psychiatric and neurological drugs with Anticholinergic Risk Scale (ARS) scores >1 (tricyclic antidepressants, paroxetine, antispasmodics, antihistamines with anticholinergic properties).
  • Active biliary disease (eg, symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the medical monitor
  • Pregnancy, breastfeeding or less than 3 months postpartum or intent to get pregnant within the next 6 months
  • Participants with any of the following:
  • history of bladder stones
  • history of recurrent urinary tract infections
  • History of unstable hypertension or tachycardia as evidenced by:
  • Blood pressure of ≥ 160/100 mmHg (seated measures) at screening
  • Heart rate of ≥ 110 bpm (seated measures) at screening
  • Clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at Screening
  • Current participation in another clinical trial, or 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

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patricia Marcy contact

9043020811

pmarcy@northwell.edu

Cristina Gonzalez contact

3478043605

cgomes@northwell.edu

United States1 site

  • Clinical Site

    Richmond, Texas, 77407

    coordinator, amnag@perceptivepharmaresearch.com

Other trials in United States

About this study

This is an open label study of the treatment satisfaction, efficacy and tolerability of xanomeline/ trospium in a population of 172 participants diagnosed with schizophrenia in the early phase of illness. Participants will be followed for 24 weeks with scheduled assessments conducted by centralized raters, local mental health professionals and self-assessments completed by patients. Recruitment will be based on insufficient efficacy of previous antipsychotic or due to dissatisfaction with treatment as a result of unacceptable side effects on previous antipsychotic/patient choice, with approximately 50% for each enrollment criteria. Participants who present with both insufficient efficacy and unacceptable side effects will be considered as belonging to the insufficient efficacy subgroup. Treatment and assessments will be identical for the 2 groups. Primary outcome for participants enrolled will be improvement in overall treatment satisfaction as measured by the MSQ.

Conditions
Schizophrenia
Being tested
Xanomeline/Trospium
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xanomeline/TrospiumDrug

    Also called Cobenfy

    Xanomeline/Trospium (titrated dose)

Study groups in NCT06923891
Study groupRoleWhat they receive
Xanomeline/TrospiumActive comparatorCobenfy
Receives: Drug: Xanomeline/Trospium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication Satisfaction Questionnaire (MSQ)

    Change in total MSQ from baseline to week 12

    Measured: 12 weeks

Secondary outcomes (8)

  1. Positive and Negative Syndrome Scale (PANSS)

    PANSS total score from baseline to week 12

    Measured: 12 weeks

  2. Clinical Global Impression - Severity Scale (CGI-S)

    CGI-S score from baseline to week 12

    Measured: 12 weeks

  3. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Change in TSMQ global satisfaction from baseline to week 12

    Measured: 12 weeks

  4. Personal and social performance scale (PSP)

    Personal and social performance scale (PSP) scores from baseline to week 12

    Measured: 12 weeks

  5. All cause discontinuation

    All-cause and specific-cause discontinuation by week 12

    Measured: 12 weeks

  6. Merck Adherence Estimator

    Adherence (Merck Adherence Estimator), from baseline to week 12

    Measured: 12 weeks

  7. Adverse Effects

    Incidence of adverse effects for overall study period to and of safety follow up by week 12

    Measured: 12 weeks

  8. Columbia Suicidal Severity Rating Scale (C-SSRS)

    Columbia Suicidal Severity Rating Scale (C-SSRS) by week 12

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2025
  2. Study start16 Apr 2025 (estimated)
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06923891
Sponsor's protocol ID
FEP Cobenfy
Status last verified
Apr 2025
First submitted
4 Apr 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

Publications

  • Howes OD, McCutcheon R, Agid O, de Bartolomeis A, van Beveren NJ, Birnbaum ML, Bloomfield MA, Bressan RA, Buchanan RW, Carpenter WT, Castle DJ, Citrome L, Daskalakis ZJ, Davidson M, Drake RJ, Dursun S, Ebdrup BH, Elkis H, Falkai P, Fleischacker WW, Gadelha A, Gaughran F, Glenthoj BY, Graff-Guerrero A, Hallak JE, Honer WG, Kennedy J, Kinon BJ, Lawrie SM, Lee J, Leweke FM, MacCabe JH, McNabb CB, Meltzer H, Moller HJ, Nakajima S, Pantelis C, Reis Marques T, Remington G, Rossell SL, Russell BR, Siu CO, Suzuki T, Sommer IE, Taylor D, Thomas N, Ucok A, Umbricht D, Walters JT, Kane J, Correll CU. Treatment-Resistant Schizophrenia: Treatment Response and Resistance in Psychosis (TRRIP) Working Group Consensus Guidelines on Diagnosis and Terminology. Am J Psychiatry. 2017 Mar 1;174(3):216-229. doi: 10.1176/appi.ajp.2016.16050503. Epub 2016 Dec 6.

    PubMed 27919182

  • Logan F, Marsh M, Hively A, Warner J, Davis A, Jackson JL, Black W. Resilience factors, pain, and physical activity in adolescent chronic musculoskeletal pain: Design and protocol of a pilot phase 2 single-group, non-randomized clinical trial. PLoS One. 2026 Jul 30;21(7):e0353010. doi: 10.1371/journal.pone.0353010. eCollection 2026.

    PubMed 42531291

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Xanomeline/Trospium in people with Schizophrenia, run by Vanguard Research Group at 1 site 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 17 inclusion and 31 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 1 site 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?

Contact Patricia Marcy (9043020811, pmarcy@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication Satisfaction Questionnaire (MSQ) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06923891, which also lists 2 linked publications.

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.

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