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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524062-16-00 | Other Identifier | EU CT Number | |
| U1111-1325-9994 | Other Identifier | UTN |
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The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of KarXT for Schizophrenia | Experimental |
| |
| Administration of KarXT for Autism-related Irritability | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KarXT | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) | Up to 54 weeks | |
| Number of participants with adverse events of special interest (AESIs) | Up to 54 weeks | |
| Number of participants with serious adverse events (SAEs) | Up to 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number or participants with procholinergic symptoms | Up to 54 weeks | |
| Number of participants with anticholinergic symptoms | Up to 54 weeks | |
| Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) |
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Inclusion Criteria
- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.
Exclusion Criteria
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| 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 |
|---|---|---|---|---|---|---|
| Advanced Research Center Inc. | Recruiting | Anaheim | California | 92805 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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
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| Up to 54 weeks |
| Change from baseline on the Simpson-Angus Scale (SAS) | Up to 52 weeks |
| Change from baseline on the Abnormal Involuntary Movement Scale (AIMS) | Up to 52 weeks |
| Change from baseline on the Barnes-Akathisia Rating Scale (BARS) | Up to 52 weeks |
| Inland Psychiatric Medical Group. | Recruiting | Chino | California | 91710 | United States |
|
| Local Institution - 0024 | Not yet recruiting | Culver City | California | 90230 | United States |
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| Local Institution - 0083 | Not yet recruiting | Redlands | California | 92373 | United States |
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| Local Institution - 0089 | Not yet recruiting | San Francisco | California | 94158 | United States |
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| Apg Research, Llc | Recruiting | Orlando | Florida | 32803 | United States |
|
| Atlanta Center for Medical Research | Recruiting | Atlanta | Georgia | 30331 | United States |
|
| Salveo Integrative Health - Lawrenceville | Recruiting | Lawrenceville | Georgia | 30046 | United States |
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| Denali Health Atlanta, LLC | Recruiting | Stone Mountain | Georgia | 30083 | United States |
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| EmVenio Research Center - Prime Healthcare | Recruiting | Chicago | Illinois | 60622 | United States |
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| Local Institution - 0076 | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
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| Local Institution - 0059 | Not yet recruiting | Worcester | Massachusetts | 01608 | United States |
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| Local Institution - 0061 | Not yet recruiting | Great Neck | New York | 11021 | United States |
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| University of Cincinnati Cancer Institute | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| Local Institution - 0137 | Not yet recruiting | Nashville | Tennessee | 37212 | United States |
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| Local Institution - 0046 | Not yet recruiting | Garland | Texas | 75043 | United States |
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| Local Institution - 0066 | Not yet recruiting | Spring | Texas | 77381 | United States |
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| Local Institution - 0050 | Not yet recruiting | Richmond | Virginia | 23284 | United States |
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| Local Institution - 0084 | Not yet recruiting | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1107 | Argentina |
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| Local Institution - 0085 | Not yet recruiting | La Plata | Buenos Aires | 1900 | Argentina |
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| Local Institution - 0036 | Withdrawn | Buenos Aires | C1405BOA | Argentina |
| Local Institution - 0035 | Not yet recruiting | Córdoba | X5003DCE | Argentina |
|
| Local Institution - 0116 | Not yet recruiting | Santiago del Estero | G4200DND | Argentina |
|
| Local Institution - 0111 | Not yet recruiting | Edmonton | Alberta | T6G 1Z1 | Canada |
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| Local Institution - 0110 | Not yet recruiting | Kingston | Ontario | K7L4X3 | Canada |
|
| Local Institution - 0113 | Not yet recruiting | Toronto | Ontario | M4G 1R8 | Canada |
|
| Local Institution - 0112 | Not yet recruiting | Montreal | Quebec | H3T 1C5 | Canada |
|
| Local Institution - 0118 | Not yet recruiting | Bordeaux | 33076 | France |
|
| Local Institution - 0120 | Not yet recruiting | Bron | 69678 | France |
|
| Local Institution - 0119 | Not yet recruiting | Paris | 75019 | France |
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| Local Institution - 0121 | Not yet recruiting | Gdansk | 80-546 | Germany |
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| Local Institution - 0129 | Not yet recruiting | Budapest | 1143 | Hungary |
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| Local Institution - 0130 | Not yet recruiting | Gyula | 5700 | Hungary |
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| Local Institution - 0131 | Not yet recruiting | Szeged | 6720 | Hungary |
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| Local Institution - 0075 | Not yet recruiting | Chikugo | Fukuoka | 833-0041 | Japan |
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| Goryokai Medical Corporation - Goryokai Hospital | Recruiting | Sapporo | Hokkaido | 002-8029 | Japan |
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| Local Institution - 0025 | Not yet recruiting | Zentsujichó | Kagawa-ken | 765-8507 | Japan |
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| Local Institution - 0062 | Not yet recruiting | Miyakonojō | Miyazaki | 885-0093 | Japan |
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| Local Institution - 0086 | Not yet recruiting | Bunkyo-ku | Tokyo | 113-8431 | Japan |
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| Local Institution - 0056 | Not yet recruiting | Ōta-ku | Tokyo | 143-8541 | Japan |
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| Local Institution - 0063 | Not yet recruiting | Yokohama, Kanagawa | 213-8507 | Japan |
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| Local Institution - 0128 | Not yet recruiting | Poznan | Greater Poland Voivodeship | 60-744 | Poland |
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| Local Institution - 0125 | Not yet recruiting | Wroclaw | Lower Silesian Voivodeship | 54-234 | Poland |
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| Local Institution - 0122 | Not yet recruiting | Kraśnik | Lublin Voivodeship | 23-210 | Poland |
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| Local Institution - 0127 | Not yet recruiting | Warsaw | Masovian Voivodeship | 02-957 | Poland |
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| Local Institution - 0126 | Not yet recruiting | Gdansk | Pomeranian Voivodeship | 80-542 | Poland |
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| Local Institution - 0123 | Not yet recruiting | Szczecin | West Pomeranian Voivodeship | 70-419 | Poland |
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| Local Institution - 0124 | Not yet recruiting | Katowice | 40-146 | Poland |
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| Local Institution - 0029 | Not yet recruiting | Bucharest | Bucharest | 041914 | Romania |
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| Local Institution - 0031 | Not yet recruiting | Cluj-Napoca | Cluj | 400370 | Romania |
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| Local Institution - 0040 | Not yet recruiting | Bucharest | 021056 | Romania |
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| Local Institution - 0042 | Not yet recruiting | Bucharest | 031871 | Romania |
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| Local Institution - 0008 | Not yet recruiting | Iași | 700282 | Romania |
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| Local Institution - 0038 | Not yet recruiting | Timișoara | 300011 | Romania |
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| Local Institution - 0101 | Not yet recruiting | Barcelona | 08036 | Spain |
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| Local Institution - 0099 | Not yet recruiting | Barcelona | 8035 | Spain |
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| Local Institution - 0098 | Not yet recruiting | Madrid | 28007 | Spain |
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| Local Institution - 0100 | Not yet recruiting | Madrid | 28031 | Spain |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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