A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
Recruiting · NCT07288567 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
KarXTKarXT Matching Placebo
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
Who can take part
Age range
13 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
38 locations listed across 10 US states.
- Advanced Research Center Inc. - Anaheim, California, United States
- Inland Psychiatric Medical Group. - Chino, California, United States
- Proscience Research Group - Culver City, California, United States
- UCSF Neurosciences Clinical Research Unit (NCRU) - San Francisco, California, United States
- Local Institution - 0119 - Hollywood, Florida, United States
- Apg Research, Llc - Orlando, Florida, United States
- Atlanta Center for Medical Research - Atlanta, Georgia, United States
- Salveo Integrative Health - Lawrenceville - Lawrenceville, Georgia, United States
- Denali Health Atlanta, LLC - Stone Mountain, Georgia, United States
- Local Institution - 0122 - Chicago, Illinois, United States
- EmVenio Research Center - Prime Healthcare - Chicago, Illinois, United States
- Boston Children's Hospital - Boston, Massachusetts, United States
- Local Institution - 0059 - Worcester, Massachusetts, United States
- Local Institution - 0061 - Great Neck, New York, United States
- University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience - Cincinnati, Ohio, United States
- Local Institution - 0113 - Nashville, Tennessee, United States
- VAST Clinical Research - Garland, Texas, United States
- Local Institution - 0120 - Houston, Texas, United States
- Local Institution - 0066 - Spring, Texas, United States
- Local Institution - 0050 - Richmond, Virginia, United States
- Local Institution - 0001 - Barranquilla, Colombia
- Local Institution - 0020 - Bogotá, Colombia
- Clinica Animedica Bucuresti - Bucharest, Romania
- Cabinet Medical Individual Dr Gheorghita Karina Lidia - Bucharest, Romania
- Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry - Cluj-Napoca, Romania
- Local Institution - 0008 - Iași, Romania
- Local Institution - 0030 - Sibiu, Romania
- Emergency Clinical Hospital For Children Louis Turcanu Timis - Timișoara, Romania
- Local Institution - 0063 - Yokohama, Kanagawa, Japan
- Local Institution - 0109 - Bello, Antioquia, Colombia
- Local Institution - 0029 - Bucharest, Bucharest, Romania
- Local Institution - 0075 - Chikugo-Shi, Fukuoka, Japan
- Goryokai Medical Corporation - Goryokai Hospital - Sapporo, Hokkaido, Japan
- Local Institution - 0025 - Zentsujichó, Kagawa-ken, Japan
- Local Institution - 0062 - Miyakonojō, Miyazaki, Japan
- Local Institution - 0009 - Pereira, Risaralda Department, Colombia
- Local Institution - 0086 - Bunkyo-ku, Tokyo, Japan
- Local Institution - 0056 - Ōta-ku, Tokyo, Japan