Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of KarXT | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KarXT | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score | Double-Blind Part | At week 5 |
| Number of participants with treatment-emergent adverse events (TEAEs) | Open-label extension (OLE) Part | At Week 52 from OLE baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in PANSS positive score | Double-blind Part | At week 5 |
| Change from baseline in PANSS negative score | Double-blind Part |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotei Hospital | Recruiting | Kōnan | Aichi-ken | 4838248 | Japan |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Specified dose on specified days |
|
| At week 5 |
| Change from baseline in PANSS Negative Marder Factor score | Double-blind Part | At week 5 |
| Change from baseline in Clinical Global Impressions-Severity (CGI-S) score | Double-blind Part | At week 5 |
| The percentage of PANSS responders (a ≥ 30% change in PANSS total score) | Double-blind Part | At week 5 |
| Number of participants wtih adverse events (AEs) | Double-blind Part | Up to day 35 |
| 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 | Double-blind Part | Up to day 35 |
| Change from baseline in Barnes Akathisia Rating Scale (BARS) score | Double-blind Part | Up to day 35 |
| Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score | Double-blind Part | Up to day 35 |
| Change from baseline in body weight | Double-blind Part | Up to day 35 |
| Change from baseline in body mass index (BMI) | Double-blind Part | Up to day 35 |
| 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) | Male participants ≥ 45 years of age only | Up to week 57 |
| Area under the plasma concentration-time curve (AUC) | Double-blind Part | Up to day 35 |
| Maximum observed plasma concentration (Cmax) | Double-blind Part | Up to day 35 |
| Time of maximum observed plasma concentration (Tmax) | Double-blind Part | Up to day 35 |
| Number of participants wtih serious TEAEs | OLE Part | Up to week 57 |
| Number of participants wtih TEAEs leading to discontinuation of study intervention | OLE Part | Up to week 57 |
| Change from OLE baseline in PANSS total score | OLE Part | At week 57 |
| Change from OLE baseline in CGI-S score | OLE Part | At week 57 |
| Percentage of PANSS responders | OLE Part | At week 57 |
| Local Institution - 0056 | Not yet recruiting | Nagoya | Aichi-ken | 466-8560 | Japan |
|
| Okehazama Hospital | Recruiting | Toyoake | Aichi-ken | 470-1168 | Japan |
|
| Fujita Health University | Recruiting | Toyoake | Aichi-ken | 470-1192 | Japan |
|
| National Kohnodai Medical Center. | Recruiting | Ichikawa | Chiba | 272-8516 | Japan |
|
| National Hospital Organization Shimofusa Psychiatric Medical Center | Recruiting | MIdori-ku, Chiba-shi | Chiba | 266-0007 | Japan |
|
| Local Institution - 0032 | Withdrawn | Iizuka | Fukuoka | 820-0014 | Japan |
| Local Institution - 0037 | Not yet recruiting | Kitakyushu | Fukuoka | 803-0831 | Japan |
|
| Shiranui Hospital | Recruiting | Omuta | Fukuoka | 836-0004 | Japan |
|
| Takeda General Hospital - Aizuwakamatsu | Recruiting | Aizu-Wakamatsu | Fukushima | 965-0876 | Japan |
|
| Holy Cross Hospital - Toki | Recruiting | Toki | Gifu | 509-5142 | Japan |
|
| Kure Medical Center | Recruiting | Kure | Hiroshima | 737-0023 | Japan |
|
| Goryokai Medical Corporation - Goryokai Hospital | Recruiting | Sapporo | Hokkaido | 002-8029 | Japan |
|
| Hokkaido University Hospital | Recruiting | Sapporo | Hokkaido | 0608648 | Japan |
|
| Local Institution - 0025 | Not yet recruiting | Hadano-shi | Kanagawa | 257-0003 | Japan |
|
| Fujimidai Hospital | Recruiting | Hiratsuka | Kanagawa | 259-1205 | Japan |
|
| Kitasato University Hospital | Recruiting | Sagamihara | Kanagawa | 252-0375 | Japan |
|
| Tsurumi Nishii Hospital | Recruiting | Yokohama | Kanagawa | 230-0074 | Japan |
|
| Yokohama City University Medical Center | Recruiting | Yokohama | Kanagawa | 232-0024 | Japan |
|
| Hino Hospital - Yokohama | Recruiting | Yokohama | Kanagawa | 234-0051 | Japan |
|
| Yuge Hospital | Recruiting | Kumamoto | Kumamoto | 861-8002 | Japan |
|
| Local Institution - 0019 | Withdrawn | Yatsushiro | Kumamoto | 866-0043 | Japan |
| National Hospital Organization Maizuru Medical Center | Recruiting | Maizuru | Kyoto | 625-8502 | Japan |
|
| Miyakonojo Shinsei Hospital | Recruiting | Miyakonojō | Miyazaki | 885-0093 | Japan |
|
| Local Institution - 0014 | Withdrawn | Komoro | Nagano | 384-8540 | Japan |
| Local Institution - 0050 | Withdrawn | Matsumoto | Nagano | 390-0847 | Japan |
| University of the Ryukyus Hospital | Recruiting | Ginowan | Okinawa | 901-2725 | Japan |
|
| Osaka Psychiatric Medical Center | Recruiting | Hirakata | Osaka | 573-0022 | Japan |
|
| Kansai Medical University Medical Center | Recruiting | Moriguchi | Osaka | 570-8507 | Japan |
|
| Nagaokai Medical Corporation - Neyagawa Sanatorium | Recruiting | Neyagawa | Osaka | 572-0854 | Japan |
|
| Shin-Abuyama Hospital | Recruiting | Takatsuki | Osaka | 569-1041 | Japan |
|
| Osaka Medical and Pharmaceutical University Hospital | Recruiting | Takatsuki | Osaka | 569-8686 | Japan |
|
| Rainbow and Sea Hospital | Recruiting | Karatsu-shi | Saga-ken | 847-0031 | Japan |
|
| Inuo Hospital | Recruiting | Tosu | Saga-ken | 841-0081 | Japan |
|
| Saitama Konan Hospital | Recruiting | Kumagaya | Saitama | 360-0114 | Japan |
|
| Dokkyo Medical University Hospital | Recruiting | Shimotsuga | Tochigi | 321-0293 | Japan |
|
| Local Institution - 0054 | Not yet recruiting | Shimotsuke | Tochigi | 329-0498 | Japan |
|
| Local Institution - 0043 | Not yet recruiting | Utsunomiya | Tochigi | 3291104 | Japan |
|
| Local Institution - 0012 | Withdrawn | Hachiōji | Tokyo | 192-0153 | Japan |
| National Center of Neurology and Psychiatry | Recruiting | Kodaira | Tokyo | 187-8551 | Japan |
|
| Asuka Hospital | Recruiting | Machida | Tokyo | 1940005 | Japan |
|
| Toho University Omori Medical Center | Recruiting | Ōta-ku | Tokyo | 143-8541 | Japan |
|
| Tokyo Metropolitan Matsuzawa Hospital | Recruiting | Setagaya City | Tokyo | 1560057 | Japan |
|
| Narimasu Kosei Hospital | Recruiting | tabashi City | Tokyo | 175-0091 | Japan |
|
| Yamaguchi University Hospital | Recruiting | Ube | Yamaguchi | 755-8505 | Japan |
|
| Kuramitsu Hospital | Recruiting | Fukuoka | 819-0037 | Japan |
|
| University Hospital,Kyoto Prefectural University of Medicine | Recruiting | Kyoto | 602-8566 | Japan |
|
| Miyazaki Prefectural Miyazaki Hospital | Recruiting | Miyazaki | 880-8510 | Japan |
|
| Okayama University Hospital | Recruiting | Okayama | 700-8558 | Japan |
|
| Local Institution - 0018 | Not yet recruiting | Okinawa | 904-0012 | Japan |
|
| Local Institution - 0031 | Not yet recruiting | Osaka | 590-0018 | Japan |
|
| Saitama Neuropsychitric Institute | Recruiting | Saitama | 338-8577 | Japan |
|
| Tokushima University Hospital | Recruiting | Tokushima | 770-8503 | Japan |
|
| Local Institution - 0033 | Withdrawn | Tottori | 689-0203 | Japan |
| Wakayama Medical University Hospital | Recruiting | Wakayama | 641-8510 | Japan |
|
| Yamagata Sakuracho Hospital | Recruiting | Yamagata | 990-0045 | Japan |
|
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided