SHINENCT07084831

A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia

StatusWithdrawn

PhasePhase 3

SponsorEuropean Group for Research In Schizophrenia

Primary completionJan 1, 2029 (estimated)

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

Stopped Oct 28, 2026 Withdrawn before enrolling Sponsor's reason: Ethical committee in Europe did not provide approval Show 5 more changesShow less
- Enrollment target: estimated 171 to confirmed 0
- Interventions: Xanomeline/trospium (Drug) to Xanomeline/trospium (Drug)
- Eligibility criteria expanded, about 19 words
- Secondary endpoints: details revised at 1 of 1 entry
- Site contacts updated at 16 of 16 sites
Notable May 12, 2026 Primary completion pushed from Jan 1, 2028 to Jan 1, 2029v3 Show 4 more changesShow less
- Start date: Jan 14, 2026 to Jan 1, 2027
- Trial status changed: Recruiting → Not Yet Recruiting
- Study completion pushed from Jul 1, 2028 to Jul 1, 2029
- Site details revised at 16 of 16 sites
Notable Feb 27, 2026 Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
- Study sites: 2 to 16
- Start date changed from estimate of Jan 1, 2026 to Jan 14, 2026
- Eligibility criteria expanded, about 214 words
- Secondary endpoints: 2 to 1
- Study description expanded, about 10 words
- Study title shortened, about 2 words
Jul 23, 2025 Study First Submitted

Stopped: terminated, suspended or withdrawn
Notable: the plan changed

Endpoints

Primary

Change in cognitive performance after 24 weeks of treatment, relative to baseline.

Timeframe: 24 weeks

Secondary (1)

Change in negative symptoms after 24 weeks of treatment, relative to baseline.

Arms and interventions

Xanomeline/trospiumExperimental

Xanomeline/trospium that is provided to all participants

Drugs: Xanomeline/trospium

Sites

16 sites in 10 countries

Germany 4, Spain 3, Italy 2, Austria 1, Belgium 1, Czechia 1, Denmark 1, Hungary 1, Israel 1, Netherlands 1

About this trial

Schizophrenia is a long-lasting and serious mental health disorder that affects about 1% of people worldwide. It can cause symptoms such as hallucinations and delusions (called positive symptoms), confused or disorganized thinking, reduced motivation and emotional expression (negative symptoms), difficulties with memory and concentration (cognitive symptoms), and movement problems like restlessness or slowed activity. Current treatments, called antipsychotics, mainly work by blocking dopamine in the brain. These medicines are helpful for hallucinations and delusions, but they do little to improve negative or cognitive symptoms. A new medicine, Xanomeline/Trospium (XT), works differently. It targets a brain system called the muscarinic acetylcholine receptors while limiting side effects elsewhere in the body. Clinical trials have shown that XT reduces psychotic symptoms effectively and is generally well tolerated. The FDA approved XT in 2024 for adults with schizophrenia. Importantly, early results also suggest that XT may help improve thinking and memory (cognition domains), though this has not yet been studied in depth. Most schizophrenia drug studies pay little attention to long-term changes in cognition, often using only short screening tests. This study will be the first to take a deep look at cognitive function over a full year of XT treatment. It will also examine how changes in thinking skills connect with other aspects of life, such as symptom control, daily functioning, and quality of life. By making cognition a central outcome, the study responds to an urgent need in schizophrenia research: moving beyond just controlling hallucinations and delusions toward improving real-world recovery. The results could help shape future treatment strategies and support the idea that cognition should be a core treatment target in schizophrenia.

Trial details

Started: Jan 1, 2027
Study completion: Jul 1, 2029 (estimated)
Eligibility: 18 to 55, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Oversight: Data monitoring committee
Conditions: Cognitive Dysfunction, Psychotic Disorders, Schizophrenia, Schizophrenia; Psychosis, Cognitive Impairment
Collaborators: Bristol-Myers Squibb, University Medical Center Groningen
Official title: A Prospective, Open-label, Single-arm, Multicenter Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia
First posted: Jul 25, 2025
Registry updated: Oct 30, 2026
Last verified: Oct 2026

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