Clinical Trials in Japan / NCT07288567
Recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
NCT07288567 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Schizophrenia
Investigational drug(s) / intervention(s)
KarXT →KarXT Matching Placebo
KarXT: Specified dose on specified days
KarXT Matching Placebo: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
Eligibility
Inclusion Criteria:
* Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).
* PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).
* Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).
Exclusion Criteria:
* Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.
* History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
* All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.
* Any neurological disorder, except for Tourette's Syndrome.
* Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score — Week 5
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| Advanced Research Center Inc. | Anaheim | California | Recruiting |
| Inland Psychiatric Medical Group. | Chino | California | Recruiting |
| Proscience Research Group | Culver City | California | Recruiting |
| UCSF Neurosciences Clinical Research Unit (NCRU) | San Francisco | California | Recruiting |
| Local Institution - 0119 | Hollywood | Florida | Not Yet Recruiting |
| Apg Research, Llc | Orlando | Florida | Recruiting |
| Atlanta Center for Medical Research | Atlanta | Georgia | Recruiting |
| Salveo Integrative Health - Lawrenceville | Lawrenceville | Georgia | Recruiting |
| Denali Health Atlanta, LLC | Stone Mountain | Georgia | Recruiting |
| Local Institution - 0122 | Chicago | Illinois | Not Yet Recruiting |
| EmVenio Research Center - Prime Healthcare | Chicago | Illinois | Recruiting |
| Boston Children's Hospital | Boston | Massachusetts | Recruiting |
| Local Institution - 0059 | Worcester | Massachusetts | Not Yet Recruiting |
| Local Institution - 0061 | Great Neck | New York | Not Yet Recruiting |
| University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience | Cincinnati | Ohio | Recruiting |
| Local Institution - 0113 | Nashville | Tennessee | Not Yet Recruiting |
| VAST Clinical Research | Garland | Texas | Recruiting |
| Memorial Hermann | Houston | Texas | Recruiting |
| Local Institution - 0066 | Spring | Texas | Not Yet Recruiting |
| Local Institution - 0050 | Richmond | Virginia | Not Yet Recruiting |
| Local Institution - 0109 | Bello | Antioquia | Not Yet Recruiting |
| Local Institution - 0009 | Pereira | Risaralda Department | Not Yet Recruiting |
| Local Institution - 0001 | Barranquilla | Colombia | Not Yet Recruiting |
| Local Institution - 0075 | Chikugo-Shi | Fukuoka | Not Yet Recruiting |
| Goryokai Medical Corporation - Goryokai Hospital | Sapporo | Hokkaido | Recruiting |
| Local Institution - 0025 | Zentsujichó | Kagawa-ken | Not Yet Recruiting |
| Local Institution - 0062 | Miyakonojō | Miyazaki | Not Yet Recruiting |
| Local Institution - 0086 | Bunkyo-ku | Tokyo | Not Yet Recruiting |
| Local Institution - 0056 | Ōta-ku | Tokyo | Not Yet Recruiting |
| Local Institution - 0063 | Yokohama, Kanagawa | Japan | Not Yet Recruiting |
| Local Institution - 0029 | Bucharest | Bucharest | Not Yet Recruiting |
| Clinica Animedica Bucuresti | Bucharest | Romania | Recruiting |
| Cabinet Medical Individual Dr Gheorghita Karina Lidia | Bucharest | Romania | Recruiting |
| Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry | Cluj-Napoca | Romania | Recruiting |
| Local Institution - 0008 | Iași | Romania | Not Yet Recruiting |
| Local Institution - 0030 | Sibiu | Romania | Not Yet Recruiting |
| Emergency Clinical Hospital For Children Louis Turcanu Timis | Timișoara | Romania | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07288567 on ClinicalTrials.gov ↗ ← All trials in Japan