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 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
250
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Hua Shi WANG
- Número de telefone: +8618601287374
- E-mail: shihua.wang@zailaboratory.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
In Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
KarXTtreatment pattern according to clinicians'decision
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
KarXT Safety Profile
Prazo: through Week 17
|
Proportion (%)of KarXT-related adverse events (TRAEs) through Week 17
|
through Week 17
|
|
KarXT Treatment PatternAccording to Clinicians'Decision
Prazo: 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
Prazo: through Week 17
|
Proportion (%)of serious adverse events (SAEs) through Week 17
|
through Week 17
|
|
KarXT Treatment Effectiveness
Prazo: Week 17
|
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 17
|
Week 17
|
|
KarXT Treatment Effectiveness
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in social functional recovery metrics captured via continuous wearable wristband device
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
20 de setembro de 2026
Conclusão Primária (Estimado)
31 de agosto de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
30 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de agosto de 2026
Primeira postagem (Real)
3 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ZL-2701-007
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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