Health TrialsbyHealthPanel

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

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBristol-Myers Squibb

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • KarXT

    Drug

    Specified dose on specified days

  • Placebo

    Other intervention

    Specified dose on specified days

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Administration of KarXTActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

Double-Blind Part

Time frame
At week 5
2

Number of participants with treatment-emergent adverse events (TEAEs)

Open-label extension (OLE) Part

Time frame
At Week 52 from OLE baseline

Secondary outcomes

1

Change from baseline in PANSS positive score

Double-blind Part

Time frame
At week 5
2

Change from baseline in PANSS negative score

Double-blind Part

Time frame
At week 5
3

Change from baseline in PANSS Negative Marder Factor score

Double-blind Part

Time frame
At week 5
4

Change from baseline in Clinical Global Impressions-Severity (CGI-S) score

Double-blind Part

Time frame
At week 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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