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Recruiting NCT06882785

A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia

Phase III Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KarXT, Placebo.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia

Overview

The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia

Interventions

  • Drug KarXT
    Specified dose on specified days
  • Other Placebo
    Specified dose on specified days

Primary outcome measures

  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [Time frame: At week 5]
  • Number of participants with treatment-emergent adverse events (TEAEs) [Time frame: At Week 52 from OLE baseline]
Secondary outcome measures (12)
  • Change from baseline in PANSS positive score [Time frame: At week 5]
  • Change from baseline in PANSS negative score [Time frame: At week 5]
  • Change from baseline in PANSS Negative Marder Factor score [Time frame: At week 5]
  • Change from baseline in Clinical Global Impressions-Severity (CGI-S) score [Time frame: At week 5]
  • The percentage of PANSS responders (a ≥ 30% change in PANSS total score) [Time frame: At week 5]
  • Number of participants wtih adverse events (AEs) [Time frame: Up to day 35]
  • Number of participants wtih adverse events of special interest (AESIs) [Time frame: Up to week 57]
  • Number of participants with procholinergic symptoms [Time frame: Up to week 57]
  • Number of participants with anticholinergic symptoms [Time frame: Up to week 57]
  • Change from baseline in Simpson-Angus Scale (SAS) score [Time frame: Up to day 35]
  • Change from baseline in Barnes Akathisia Rating Scale (BARS) score [Time frame: Up to day 35]
  • Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score [Time frame: Up to day 35]

Eligibility criteria

Inclusion criteria

  • Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI).
  • Participants must have a PANSS total score between 80 and 120, inclusive.
  • Participants must have a CGI-S score of ≥ 4.

Exclusion criteria

  • Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
  • Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.
  • Participants must not have any history or presence of clinically significant medical conditions.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Japan · 56 centers
  • Hotei Hospital — Kōnan
  • Local Institution - 0056 — Nagoya
  • Okehazama Hospital — Toyoake
  • Fujita Health University — Toyoake
  • National Kohnodai Medical Center. — Ichikawa
  • National Hospital Organization Shimofusa Psychiatric Medical Center — MIdori-ku, Chiba-shi
  • Local Institution - 0032 — Iizuka
  • Local Institution - 0037 — Kitakyushu
  • … and 48 more centers

Identifiers

NCT: NCT06882785 · CN012-0019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗