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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 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

250

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

In Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria

Beschrijving

Inclusion Criteria:

  1. Adult participants (age: ≥18 and ≤65 years) who meet the ICD-10 diagnostic criteria for schizophrenia.
  2. 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:

  1. 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.
  2. 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).
  3. 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.
  4. 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.
  5. Participants who are pregnant, planning to become pregnant, or breastfeeding.
  6. Participants who have any medical conditions that in the investigator's opinion should exclude them from starting KarXT or participate in this study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
KarXT Treatment Cohort
The participant is capable of providing written informed consent in this study, agrees to receive KarXT monotherapy
Geneesmiddel: Xanomeline and trospium chloride (KarXT)

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
KarXTtreatment pattern according to clinicians'decision
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
KarXT Safety Profile
Tijdsspanne: through Week 17
Proportion (%)of KarXT-related adverse events (TRAEs) through Week 17
through Week 17
KarXT Treatment PatternAccording to Clinicians'Decision
Tijdsspanne: 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
Tijdsspanne: through Week 17
Proportion (%)of serious adverse events (SAEs) through Week 17
through Week 17
KarXT Treatment Effectiveness
Tijdsspanne: Week 17
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 17
Week 17
KarXT Treatment Effectiveness
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in social functional recovery metrics captured via continuous wearable wristband device
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and Week 17
Change from baseline in participant treatment satisfaction measured by the Medication Satisfaction Questionnaire (MSQ)
Baseline and Week 17

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zai Lab (Shanghai) Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 september 2026

Primaire voltooiing (Geschat)

31 augustus 2027

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

30 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 augustus 2026

Eerst geplaatst (Werkelijk)

3 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 september 2026

Laatste update ingediend die voldeed aan QC-criteria

30 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ZL-2701-007

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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Abonneren