CLINICAL TRIALS PROFILE FOR TROSPIUM CHLORIDE; XANOMELINE TARTRATE
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All Clinical Trials for TROSPIUM CHLORIDE; XANOMELINE TARTRATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02831231 ↗ | Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium | Completed | Karuna Pharmaceuticals | Phase 1 | 2016-09-07 | This study is intended to determine whether the addition of trospium chloride to xanomeline tartrate will ameliorate the peripheral cholinergic side effects that have been previously experienced with xanomeline tartrate when administered alone. |
| NCT02831231 ↗ | Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium | Completed | Karuna Therapeutics | Phase 1 | 2016-09-07 | This study is intended to determine whether the addition of trospium chloride to xanomeline tartrate will ameliorate the peripheral cholinergic side effects that have been previously experienced with xanomeline tartrate when administered alone. |
| NCT06937229 ↗ | A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) | NOT_YET_RECRUITING | Bristol-Myers Squibb | PHASE3 | 2025-11-21 | The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024. |
| NCT07084831 ↗ | A Prospective, Open-label, Single-arm, Multicenter Study Evaluating the Efficacy of One Year Treatment With Xanomeline/Trospium on Cognitive Impairment in Clinically Stable Adult Participants With Schizophrenia. | NOT_YET_RECRUITING | Bristol-Myers Squibb | PHASE3 | 2026-01-01 | Schizophrenia is a chronic, severe psychiatric disorder affecting approximately 1% of the global population. Symptoms are usually treated with antipsychotics (AP). All currently available APs work by blocking dopamine receptors in the brain. This is effective to treat the symptoms, but also leads to side-effects. Side effects contribute to poor medication adherence, resulting in frequent relapses and hospitalizations. In addition, the cognitive symptoms are not treated by the current APs. Xanomeline/Trospium (US brand name: COBENFY) is a novel combination of xanomeline tartrate (a muscarinic agonist) and trospium chloride (a muscarinic antagonist). It offers significant therapeutic benefits through its unique mechanism of action, selectively targeting central muscarinic acetylcholine receptors while mitigating peripheral side effects. This makes Xanomeline/Trospium a promising alternative to existing antipsychotics. This combination has demonstrated robust efficacy in reducing psychotic symptoms in recent trials, with a favorable side-effect profile. These findings led to the FDA approval of Xanomeline/Trospium (Cobenfy) in 2024 for the treatment of schizophrenia. Preliminary exploratory cognitive assessments in these trials have suggested potential pro-cognitive effects, particularly in domains such as attention and working memory, although these were not powered to detect changes in cognition 1,2. Most antipsychotic trials include only superficial cognitive assessments, often limited to brief screening tools or exploratory endpoints. Furthermore, few studies explore the longitudinal course of cognition over extended treatment periods. In the current study, we propose to conduct a deep-dive into cognitive functioning in patients with schizophrenia who are treated with Xanomeline/Trospium for a one-year period. Cognitive functioning is highly integrated within the study design with other relevant domains, such as clinical symptoms, functioning, and quality of life, offering a more holistic picture of treatment impact. By focusing on cognition as a primary outcome in a naturalistic yet rigorous study design, this trial addresses a critical unmet need in schizophrenia research and has the potential to inform a paradigm shift in treatment strategies beyond symptom stabilization toward cognitive and functional recovery. By investing in this level of cognitive phenotyping, the study aligns with calls from both scientific and regulatory bodies for precision in cognitive outcomes and contributes to a growing body of work aimed at establishing cognition as a co-primary treatment target in schizophrenia. |
| NCT07084831 ↗ | A Prospective, Open-label, Single-arm, Multicenter Study Evaluating the Efficacy of One Year Treatment With Xanomeline/Trospium on Cognitive Impairment in Clinically Stable Adult Participants With Schizophrenia. | NOT_YET_RECRUITING | University Medical Center Groningen | PHASE3 | 2026-01-01 | Schizophrenia is a chronic, severe psychiatric disorder affecting approximately 1% of the global population. Symptoms are usually treated with antipsychotics (AP). All currently available APs work by blocking dopamine receptors in the brain. This is effective to treat the symptoms, but also leads to side-effects. Side effects contribute to poor medication adherence, resulting in frequent relapses and hospitalizations. In addition, the cognitive symptoms are not treated by the current APs. Xanomeline/Trospium (US brand name: COBENFY) is a novel combination of xanomeline tartrate (a muscarinic agonist) and trospium chloride (a muscarinic antagonist). It offers significant therapeutic benefits through its unique mechanism of action, selectively targeting central muscarinic acetylcholine receptors while mitigating peripheral side effects. This makes Xanomeline/Trospium a promising alternative to existing antipsychotics. This combination has demonstrated robust efficacy in reducing psychotic symptoms in recent trials, with a favorable side-effect profile. These findings led to the FDA approval of Xanomeline/Trospium (Cobenfy) in 2024 for the treatment of schizophrenia. Preliminary exploratory cognitive assessments in these trials have suggested potential pro-cognitive effects, particularly in domains such as attention and working memory, although these were not powered to detect changes in cognition 1,2. Most antipsychotic trials include only superficial cognitive assessments, often limited to brief screening tools or exploratory endpoints. Furthermore, few studies explore the longitudinal course of cognition over extended treatment periods. In the current study, we propose to conduct a deep-dive into cognitive functioning in patients with schizophrenia who are treated with Xanomeline/Trospium for a one-year period. Cognitive functioning is highly integrated within the study design with other relevant domains, such as clinical symptoms, functioning, and quality of life, offering a more holistic picture of treatment impact. By focusing on cognition as a primary outcome in a naturalistic yet rigorous study design, this trial addresses a critical unmet need in schizophrenia research and has the potential to inform a paradigm shift in treatment strategies beyond symptom stabilization toward cognitive and functional recovery. By investing in this level of cognitive phenotyping, the study aligns with calls from both scientific and regulatory bodies for precision in cognitive outcomes and contributes to a growing body of work aimed at establishing cognition as a co-primary treatment target in schizophrenia. |
| NCT07084831 ↗ | A Prospective, Open-label, Single-arm, Multicenter Study Evaluating the Efficacy of One Year Treatment With Xanomeline/Trospium on Cognitive Impairment in Clinically Stable Adult Participants With Schizophrenia. | NOT_YET_RECRUITING | European Group for Research In Schizophrenia | PHASE3 | 2026-01-01 | Schizophrenia is a chronic, severe psychiatric disorder affecting approximately 1% of the global population. Symptoms are usually treated with antipsychotics (AP). All currently available APs work by blocking dopamine receptors in the brain. This is effective to treat the symptoms, but also leads to side-effects. Side effects contribute to poor medication adherence, resulting in frequent relapses and hospitalizations. In addition, the cognitive symptoms are not treated by the current APs. Xanomeline/Trospium (US brand name: COBENFY) is a novel combination of xanomeline tartrate (a muscarinic agonist) and trospium chloride (a muscarinic antagonist). It offers significant therapeutic benefits through its unique mechanism of action, selectively targeting central muscarinic acetylcholine receptors while mitigating peripheral side effects. This makes Xanomeline/Trospium a promising alternative to existing antipsychotics. This combination has demonstrated robust efficacy in reducing psychotic symptoms in recent trials, with a favorable side-effect profile. These findings led to the FDA approval of Xanomeline/Trospium (Cobenfy) in 2024 for the treatment of schizophrenia. Preliminary exploratory cognitive assessments in these trials have suggested potential pro-cognitive effects, particularly in domains such as attention and working memory, although these were not powered to detect changes in cognition 1,2. Most antipsychotic trials include only superficial cognitive assessments, often limited to brief screening tools or exploratory endpoints. Furthermore, few studies explore the longitudinal course of cognition over extended treatment periods. In the current study, we propose to conduct a deep-dive into cognitive functioning in patients with schizophrenia who are treated with Xanomeline/Trospium for a one-year period. Cognitive functioning is highly integrated within the study design with other relevant domains, such as clinical symptoms, functioning, and quality of life, offering a more holistic picture of treatment impact. By focusing on cognition as a primary outcome in a naturalistic yet rigorous study design, this trial addresses a critical unmet need in schizophrenia research and has the potential to inform a paradigm shift in treatment strategies beyond symptom stabilization toward cognitive and functional recovery. By investing in this level of cognitive phenotyping, the study aligns with calls from both scientific and regulatory bodies for precision in cognitive outcomes and contributes to a growing body of work aimed at establishing cognition as a co-primary treatment target in schizophrenia. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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