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

Purpose

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

Condition

  • Schizophrenia

Eligibility

Eligible Ages
Between 13 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT
  • Drug: KarXT
    Specified dose on specified days
    Other names:
    • BMS-986510
Placebo Comparator
Placebo
  • Other: KarXT Matching Placebo
    Specified dose on specified days

Recruiting Locations

Inland Psychiatric Medical Group.
Chino, California 91710
Contact:
Nandita Puchakayala, Site 0058
909-488-9116

Apg Research, Llc
Orlando, Florida 32803
Contact:
Morteza Nadjafi, Site 0032
407-423-7149

Atlanta Center for Medical Research
Atlanta, Georgia 30331
Contact:
Elyssa Barron, Site 0057
404-881-5800

Salveo Integrative Health - Lawrenceville
Lawrenceville, Georgia 30046
Contact:
Shahzad Hashmi, Site 0106

EmVenio Research Center - Prime Healthcare
Chicago, Illinois 60622
Contact:
Mitchell Glaser, Site 0044
773-620-2995

University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio 45219
Contact:
Melissa DelBello, Site 0051

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com