Estudio de Fase 3, Multicéntrico, Aleatorizado, Doble Ciego, Controlado con Placebo para Evaluar la Eficacia y Seguridad de KarXT en el Tratamiento de la Esquizofrenia en Adolescentes (13 a 17 años de edad)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07288567Tipo: INTERVENTIONALInicio: 29 de ene de 2026Fin estimado: 18 de dic de 2029

Resumen

El propósito de este estudio es evaluar la eficacia y la seguridad de KarXT en el tratamiento de la esquizofrenia en adolescentes.

Elegibilidad

Edad mínima: 13 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

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.

Intervenciones

drug

KarXT

Specified dose on specified days

other

KarXT Matching Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0084

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site 0084

NOT_YET_RECRUITING

Local Institution - 0085

La Plata, Buenos Aires, Argentina

Site 0085

NOT_YET_RECRUITING

Local Institution - 0036

Buenos Aires, Argentina

Site 0036

NOT_YET_RECRUITING

Local Institution - 0035

Córdoba, Argentina

Site 0035

NOT_YET_RECRUITING

Local Institution - 0102

Santiago del Estero, Argentina

Site 0102

NOT_YET_RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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