A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder

Официальное название

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

Обзор

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

Вмешательства

• Препарат KarXT
  Specified dose on specified days
• Препарат KarX-EC
  Specified dose on specified days
• Препарат KarXT + KarX-EC Matching Placebo
  Specified dose on specified days

Первичные конечные точки

• Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 [Срок оценки: Week 8]

Вторичные конечные точки (12)

• Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8 [Срок оценки: Week 8]
• Number of Participants With ABC-I response at Week 8 [Срок оценки: Week 8]
• Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8 [Срок оценки: Week 8]
• Change From Baseline on the Stereotypic Behavior Subscale at Week 8 [Срок оценки: Week 8]
• Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8 [Срок оценки: Week 8]
• Change From Baseline on the Inappropriate Speech Subscale at Week 8 [Срок оценки: Week 8]
• Clinical Global Impression-Improvement (CGI-I) Score at Week 8 [Срок оценки: Week 8]
• Number of Participants With Procholinergic Symptoms [Срок оценки: Up to approximately 12 weeks]
• Number of Participants With Anticholinergic Symptoms [Срок оценки: Up to approximately 12 weeks]
• Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 12 weeks]
• Number of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 12 weeks]
• Number of Participants With Adverse Events of Special Interest (AESIs) [Срок оценки: Up to approximately 12 weeks]

Критерии участия

Критерии включения

• 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 an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).

Критерии исключения

• 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.
• Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
• Other protocol-defined Inclusion/Exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 19 центров

• Local Institution - 0062 — Phoenix
• Local Institution - 0013 — Glendale
• Local Institution - 0117 — Los Angeles
• Local Institution - 0126 — Orange
• Local Institution - 0115 — San Juan Capistrano
• Local Institution - 0116 — San Rafael
• Local Institution - 0130 — New Haven
• Local Institution - 0080 — Orlando
• … и ещё 11 центров

Польша · 8 центров

• Local Institution - 0108 — Poznan
• Local Institution - 0105 — Wroclaw
• Local Institution - 0109 — Kraśnik
• Local Institution - 0107 — Warsaw
• Local Institution - 0106 — Gdansk
• Local Institution - 0113 — Szczecin
• Local Institution - 0129 — Szczecin
• Local Institution - 0104 — Katowice

Румыния · 7 центров

• Local Institution - 0118 — Bucharest
• Local Institution - 0120 — Bucharest
• Local Institution - 0124 — Bucharest
• Local Institution - 0123 — Cluj-Napoca
• Local Institution - 0121 — Iași
• Local Institution - 0119 — Sibiu
• Local Institution - 0122 — Timișoara

Япония · 5 центров

• Local Institution - 0094 — Miyakonojō
• Local Institution - 0090 — Hirakata
• Local Institution - 0095 — Yoshinogari-cho, Kanzaki-gun
• Local Institution - 0091 — Ōta-ku
• Local Institution - 0093 — Yokohama, Kanagawa

Венгрия · 4 центра

• Local Institution - 0111 — Budapest
• Local Institution - 0127 — Budapest
• Local Institution - 0112 — Siófok
• Local Institution - 0110 — Szeged

Испания · 4 центра

• Local Institution - 0085 — Barcelona
• Local Institution - 0087 — Barcelona
• Local Institution - 0084 — Madrid
• Local Institution - 0086 — Madrid

Франция · 3 центра

• Local Institution - 0102 — Bron
• Local Institution - 0088 — Eysines
• Local Institution - 0089 — Paris

Индия · 3 центра

• Local Institution - 0096 — Kozhikode
• Local Institution - 0101 — Sakri
• Local Institution - 0097 — Kolkata

Германия · 1 центр

• Local Institution - 0103 — Gdansk

Идентификаторы

NCT: NCT07285798 · CN012-0045 · 2025-523188-39-00 · U1111-1325-5048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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