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Recruiting NCT07288567

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

Phase III Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KarXT, KarXT Matching Placebo.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Colombia, Japan, Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)

Overview

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

Interventions

  • Drug KarXT
    Specified dose on specified days
  • Other KarXT Matching Placebo
    Specified dose on specified days

Primary outcome measures

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score [Time frame: Week 5]
Secondary outcome measures (7)
  • Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score [Time frame: Week 5]
  • Change From Baseline in PANSS Positive Subscale Score [Time frame: Week 5]
  • Change From Baseline in PANSS Negative Subscale Score [Time frame: Week 5]
  • Change From Baseline in PANSS Marder Negative Factor Score [Time frame: Week 5]
  • Number of Participants With PANSS Response [Time frame: Week 5]
  • Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score [Time frame: Week 5]
  • Change From Baseline in Children's Global Assessment Scale (CGAS)) Score [Time frame: Week 5]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 21 centers
  • Advanced Research Center Inc. — Anaheim
  • Inland Psychiatric Medical Group. — Chino
  • Local Institution - 0024 — Culver City
  • Local Institution - 0083 — Redlands
  • Local Institution - 0089 — San Francisco
  • Local Institution - 0119 — Hollywood
  • Apg Research, Llc — Orlando
  • Atlanta Center for Medical Research — Atlanta
  • … and 13 more centers
Japan · 7 centers
  • Local Institution - 0075 — Chikugo-Shi
  • Goryokai Medical Corporation - Goryokai Hospital — Sapporo
  • Local Institution - 0025 — Zentsujichó
  • Local Institution - 0062 — Miyakonojō
  • Local Institution - 0086 — Bunkyo-ku
  • Local Institution - 0056 — Ōta-ku
  • Local Institution - 0063 — Yokohama, Kanagawa
Romania · 7 centers
  • Local Institution - 0029 — Bucharest
  • Local Institution - 0040 — Bucharest
  • Local Institution - 0042 — Bucharest
  • Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry — Cluj-Napoca
  • Local Institution - 0008 — Iași
  • Local Institution - 0030 — Sibiu
  • Emergency Clinical Hospital For Children Louis Turcanu Timis — Timișoara
Colombia · 4 centers
  • Local Institution - 0109 — Bello
  • Local Institution - 0009 — Pereira
  • Local Institution - 0001 — Barranquilla
  • Local Institution - 0020 — Bogotá

Identifiers

NCT: NCT07288567 · CN012-0020 · 2025-523711-11-00 · U1111-1325-9936

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗