A Prospective, Observational, Single-Arm, Multicenter Real-World Study Evaluating the Treatment Pattern, Safety and Effectiveness of Xanomeline and Trospium Chloride Capsules (KarXT) in the Treatment of Chinese Adult Participants With Schizophrenia
30 de agosto de 2026 actualizado por: Zai Lab (Shanghai) Co., Ltd.
This study is a prospective, observational, single-arm, open-label, multicenter, real-world study conducted in Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria.
The total study duration is up to 17 weeks, including a screening/baseline data collection period followed by an observational part during which KarXT treatmentpattern, schizophrenia treatment decisions and compliance will be observed in the real-world setting.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
250
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Hua Shi WANG
- Número de teléfono: +8618601287374
- Correo electrónico: shihua.wang@zailaboratory.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
In Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria
Descripción
Inclusion Criteria:
- Adult participants (age: ≥18 and ≤65 years) who meet the ICD-10 diagnostic criteria for schizophrenia.
- The participant is capable of providing written informed consent in the study, agrees to receive KarXT monotherapy, is willing to follow the protocol-specified follow-up schedule, and signs the informed consent form, or, where applicable, both the participant and the participant's legal guardian sign the informed consent form.
Exclusion Criteria:
- Participants who have contraindications listed in the prescribing information: urinary retention, moderate or severe hepatic impairment, gastric retention, history of hypersensitivity to this product or trospium chloride, or untreated narrow-angle glaucoma.
- Participants who have conditions not recommended in the prescribing information, such as moderate or severe renal impairment, mild hepatic impairment, or active biliary disease (e.g., symptomatic gallstones).
- Participants diagnosed with treatment-resistant schizophrenia (TRS), defined as having previously received at least two courses of treatment with different antipsychotic medications, with each course administered at an adequate dose, as determined by the investigator based on clinical judgment, for at least 4 weeks, but without response.
- Participants with severe suicidal ideations. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS as confirmed by the following: Answers "Yes" on items 4 or 5 (C -SSRS ideation) with the most recent episode occurring within the 2 months before screening, or answers "Yes" to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before screening. Non-suicidal self-injurious behavior is not exclusionary.
- Participants who are pregnant, planning to become pregnant, or breastfeeding.
- Participants who have any medical conditions that in the investigator's opinion should exclude them from starting KarXT or participate in this study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
KarXT Treatment Cohort
The participant is capable of providing written informed consent in this study, agrees to receive KarXT monotherapy
|
Participants will receive KarXT for a treatment/observation period of 17 weeks. The recommended dosage and administration of KarXT should refer to the prescribing information: The recommended starting dosage is one 50 mg/20 mg capsule orally twice daily for at least two days, then increase to one 100 mg/20 mg capsule orally twice daily for at least five days, the dosage may be increased to one 125 mg/30 mg capsule orally twice daily based on participant tolerability and response. All participants who are increased to 125 mg/30 mg, depending on clinician's decision, will have the option to return to 100 mg/20 mg for the remainder of the treatment/observation period. Maintenance doses may be set at 125 mg/30 mg or 100 mg/20 mg twice daily. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
KarXTtreatment pattern according to clinicians'decision
Periodo de tiempo: through Week 17
|
Treatment duration (days)for each doseof KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 17
|
through Week 17
|
|
KarXTtreatment pattern according to clinicians'decision
Periodo de tiempo: Week 17
|
Proportion(%)of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) at Week 17
|
Week 17
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
KarXT Safety Profile
Periodo de tiempo: through Week 17
|
Proportion (%)of KarXT-related adverse events (TRAEs) through Week 17
|
through Week 17
|
|
KarXT Treatment PatternAccording to Clinicians'Decision
Periodo de tiempo: through Week 5
|
Treatment duration (days) for each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5
|
through Week 5
|
|
KarXT Safety Profile
Periodo de tiempo: through Week 17
|
Proportion (%)of serious adverse events (SAEs) through Week 17
|
through Week 17
|
|
KarXT Treatment Effectiveness
Periodo de tiempo: Week 17
|
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 17
|
Week 17
|
|
KarXT Treatment Effectiveness
Periodo de tiempo: Week 17
|
Change from baseline in the Clinical Global Impression-Severity (CGI-S) score at Week 17
|
Week 17
|
|
Schizophrenia Treatment Decisions and Compliance in the Real-world Setting
Periodo de tiempo: through Week 17
|
Proportion (%) of participants discontinuing KarXT treatment along with the documented reasons for the decision from baseline through Week 17
|
through Week 17
|
|
KarXT Treatment PatternAccording to Clinicians'Decision
Periodo de tiempo: through Week 5
|
Proportion (%) of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5
|
through Week 5
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in social functional recovery metrics captured via continuous wearable wristband device
Periodo de tiempo: Baseline and Week 17
|
Change from baseline in social functional recovery metrics captured via continuous wearable wristband device (sleep onset time, wake time, total sleep duration, heart rate, heart rate variability, total daily step count, sedentary duration, and activity interruptions)
|
Baseline and Week 17
|
|
Change from baseline in the proportion of patient-reported outcome in the surveys in binary states across four Ecological Momentary Assessment (EMA) dimensions
Periodo de tiempo: Baseline and Week 17
|
Observed Ecological Momentary Assessment (EMA) patient-reported outcomes (PRO) in participants with schizophrenia: Change from baseline in the proportion of patient-reported outcome in the surveys in binary states across four Ecological Momentary Assessment (EMA) dimensions: location (at home vs. outdoors), sociality context (alone vs. with others), activity type (productive vs. non-productive), and affect profile (positive vs. negative) at Week 17
|
Baseline and Week 17
|
|
Change From Baseline in the Zarit Caregiver Burden Interview (ZBI) Score
Periodo de tiempo: Baseline and Week 17
|
Change from baseline in caregiver burden, assessed by the Zarit Caregiver Burden Interview (ZBI)
|
Baseline and Week 17
|
|
Change From Baseline in the PANSS Marder Negative Factor Score
Periodo de tiempo: Baseline and Week 17
|
Change from baseline in the PANSS Marder negative factor score
|
Baseline and Week 17
|
|
Change From Baseline in the Personal and Social Performance Scale (PSP) Score
Periodo de tiempo: Baseline and Week 17
|
Change from baseline in the Personal and Social Performance Scale (PSP) score
|
Baseline and Week 17
|
|
Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) Score
Periodo de tiempo: Baseline and Week 17
|
Change from baseline in participant treatment satisfaction measured by the Medication Satisfaction Questionnaire (MSQ)
|
Baseline and Week 17
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
20 de septiembre de 2026
Finalización primaria (Estimado)
31 de agosto de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de agosto de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ZL-2701-007
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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