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A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)

NCT07288567

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Schizophrenia

Interventions: KarXT, KarXT Matching Placebo

Countries: United States, Colombia, Japan, Romania

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.

Eligibility overview

Sex: ALL

Age: 13 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (39)
  • Anaheim, California, United States
  • Chino, California, United States
  • Culver City, California, United States
  • San Francisco, California, United States
  • Hollywood, Florida, United States
  • Orlando, Florida, United States
  • Atlanta, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Stone Mountain, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Great Neck, New York, United States
  • Cincinnati, Ohio, United States
  • Nashville, Tennessee, United States
  • Garland, Texas, United States
  • Houston, Texas, United States
  • Plano, Texas, United States
  • Spring, Texas, United States
  • Richmond, Virginia, United States
  • Bello, Antioquia, Colombia
  • Pereira, Risaralda Department, Colombia
  • Barranquilla, Colombia
  • Bogotá, Colombia
  • Chikugo-Shi, Fukuoka, Japan
  • Sapporo, Hokkaido, Japan
  • Zentsujichó, Kagawa-ken, Japan
  • Miyakonojō, Miyazaki, Japan
  • Bunkyo-ku, Tokyo, Japan
  • + 9 more on CT.gov