Schizophrenia
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
Interventions
DRUGKarXT
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score | At week 5 | Double-Blind Part |
| Number of participants with treatment-emergent adverse events (TEAEs) | At Week 52 from OLE baseline | Open-label extension (OLE) Part |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in PANSS positive score | At week 5 | Double-blind Part |
| Change from baseline in PANSS negative score | At week 5 | Double-blind Part |
| Change from baseline in PANSS Negative Marder Factor score | At week 5 | Double-blind Part |
| Change from baseline in Clinical Global Impressions-Severity (CGI-S) score | At week 5 | Double-blind Part |
| The percentage of PANSS responders (a ≥ 30% change in PANSS total score) | At week 5 | Double-blind Part |
| Number of participants wtih adverse events (AEs) | Up to day 35 | Double-blind Part |
| Number of participants wtih adverse events of special interest (AESIs) | Up to week 57 | — |
| Number of participants with procholinergic symptoms | Up to week 57 | — |
| Number of participants with anticholinergic symptoms | Up to week 57 | — |
| Change from baseline in Simpson-Angus Scale (SAS) score | Up to day 35 | Double-blind Part |
| Change from baseline in Barnes Akathisia Rating Scale (BARS) score | Up to day 35 | Double-blind Part |
| Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score | Up to day 35 | Double-blind Part |
| Change from baseline in body weight | Up to day 35 | Double-blind Part |
| Change from baseline in body mass index (BMI) | Up to day 35 | Double-blind Part |
| Blood pressure (BP) sitting and standing after 2 minutes | Up to week 57 | — |
| Heart rate (HR) sitting and standing after 2 minutes | Up to week 57 | — |
| Number of participants wtih a change from baseline in hematology evaluations | Up to week 57 | — |
| Number of participants wtih a change from baseline in clinical chemistry evaluations | Up to week 57 | — |
| Number of participants wtih a change from baseline in coagulation evaluations | Up to week 57 | — |
| Number of participants wtih a change from baseline in urinalysis evaluations | Up to week 57 | — |
| Number of participants wtih a change from baseline in drug screen evaluations | Up to week 57 | — |
| Number of participants wtih a change from baseline in 12-lead electrocardiogram (ECG) evaluations | Up to week 57 | — |
| Number of participants wtih physical examination abnormalities | Up to week 57 | — |
| Number of participants wtih suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to week 57 | — |
| International Prostate Symptom Score (IPSS) | Up to week 57 | Male participants ≥ 45 years of age only |
| Area under the plasma concentration-time curve (AUC) | Up to day 35 | Double-blind Part |
| Maximum observed plasma concentration (Cmax) | Up to day 35 | Double-blind Part |
| Time of maximum observed plasma concentration (Tmax) | Up to day 35 | Double-blind Part |
| Number of participants wtih serious TEAEs | Up to week 57 | OLE Part |
| Number of participants wtih TEAEs leading to discontinuation of study intervention | Up to week 57 | OLE Part |
| Change from OLE baseline in PANSS total score | At week 57 | OLE Part |
| Change from OLE baseline in CGI-S score | At week 57 | OLE Part |
| Percentage of PANSS responders | At week 57 | OLE Part |
Countries
Japan
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed