A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

Aún no reclutaFase 3ClinicalTrials.gov

ID: NCT07284745Tipo: INTERVENTIONALInicio: 27 de feb de 2026Fin estimado: 5 de jul de 2029

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Elegibilidad

Edad mínima: 5 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
Participants must have ABC-I ≥18 (C18 on the Irritability subscale of the ABC-I) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).

Criterios de exclusión

Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.

Intervenciones

drug

KarXT

Specified dose on specified days

drug

KarX-EC

Specified dose on specified days

drug

KarXT + KarX-EC Matching Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0046

La Plata, Buenos Aires, Argentina

Site 0046

Local Institution - 0048

Buenos Aires, Buenos Aires F.D., Argentina

Site 0048

Local Institution - 0047

Córdoba, Argentina

Site 0047

Local Institution - 0288

Córdoba, Argentina

Site 0288

Local Institution - 0049

Mendoza, Argentina

Site 0049

Local Institution - 0140

Santiago del Estero, Argentina

Site 0140

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Study Connect www.BMSStudyConnect.com

CONTACT

Clinical.Trials@bms.com 8559073286

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

CONTACT

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