RECRUITINGPhase 3INTERVENTIONAL
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
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
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
Who May Be Eligible (Plain English)
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
KarXT
Specified dose on specified days
OTHER
Placebo
Specified dose on specified days
Locations (20)
Hotei Hospital
Kōnan, Aichi-ken, Japan
Local Institution - 0056
Nagoya, Aichi-ken, Japan
Okehazama Hospital
Toyoake, Aichi-ken, Japan
Fujita Health University
Toyoake, Aichi-ken, Japan
National Kohnodai Medical Center.
Ichikawa, Chiba, Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
MIdori-ku, Chiba-shi, Chiba, Japan
Local Institution - 0032
Iizuka, Fukuoka, Japan
Local Institution - 0037
Kitakyushu, Fukuoka, Japan
Shiranui Hospital
Omuta, Fukuoka, Japan
Takeda General Hospital - Aizuwakamatsu
Aizu-Wakamatsu, Fukushima, Japan
Local Institution - 0044
Toki, Gifu, Japan
Kure Medical Center
Kure, Hiroshima, Japan
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Local Institution - 0025
Hadano-shi, Kanagawa, Japan
Fujimidai Hospital
Hiratsuka, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Tsurumi Nishii Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Hino Hospital - Yokohama
Yokohama, Kanagawa, Japan