A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

Официальное название

A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and 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 evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

Вмешательства

• Препарат KarXT
  Specified dose on specified days

Первичные конечные точки

• Number of participants with treatment emergent adverse events (TEAEs) [Срок оценки: Up to 54 weeks]
• Number of participants with adverse events of special interest (AESIs) [Срок оценки: Up to 54 weeks]
• Number of participants with serious adverse events (SAEs) [Срок оценки: Up to 54 weeks]

Вторичные конечные точки (6)

• Number or participants with procholinergic symptoms [Срок оценки: Up to 54 weeks]
• Number of participants with anticholinergic symptoms [Срок оценки: Up to 54 weeks]
• Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Up to 54 weeks]
• Change from baseline on the Simpson-Angus Scale (SAS) [Срок оценки: Up to 52 weeks]
• Change from baseline on the Abnormal Involuntary Movement Scale (AIMS) [Срок оценки: Up to 52 weeks]
• Change from baseline on the Barnes-Akathisia Rating Scale (BARS) [Срок оценки: Up to 52 weeks]

Критерии участия

Критерии включения

\- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

Критерии исключения

• Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.
• Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.
• Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.
• Other protocol-defined Inclusion/Exclusion criteria apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 51 центр

• Local Institution - 0054 — Dothan
• Local Institution - 0163 — Phoenix
• Advanced Research Center Inc. — Anaheim
• Local Institution - 0159 — Anaheim
• Inland Psychiatric Medical Group. — Chino
• Local Institution - 0024 — Culver City
• Local Institution - 0162 — Glendale
• Local Institution - 0153 — Los Angeles
• … и ещё 43 центра

Япония · 7 центров

• Local Institution - 0075 — Chikugo
• 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

Польша · 7 центров

• Local Institution - 0128 — Poznan
• Local Institution - 0125 — Wroclaw
• … и ещё 5 центров

Румыния · 6 центров

Список центров уточняется — проверьте первичный протокол.

Аргентина · 5 центров

• Local Institution - 0084 — Ciudad Autónoma de Buenos Aires
• Local Institution - 0085 — La Plata
• Local Institution - 0036 — Buenos Aires
• Local Institution - 0035 — Córdoba
• Local Institution - 0116 — Santiago del Estero

Австралия · 4 центра

• Local Institution - 0107 — Westmead
• Local Institution - 0106 — Brisbane
• Local Institution - 0108 — Melbourne
• Local Institution - 0109 — Melbourne

Канада · 4 центра

• Local Institution - 0111 — Edmonton
• Local Institution - 0110 — Kingston
• Local Institution - 0113 — Toronto
• Local Institution - 0112 — Montreal

Испания · 4 центра

Список центров уточняется — проверьте первичный протокол.

Франция · 3 центра

• Local Institution - 0118 — Bordeaux
• Local Institution - 0120 — Bron
• Local Institution - 0119 — Paris

Венгрия · 3 центра

• Local Institution - 0129 — Budapest
• Local Institution - 0130 — Gyula
• Local Institution - 0131 — Szeged

Германия · 1 центр

• Local Institution - 0121 — Gdansk

Идентификаторы

NCT: NCT07424404 · CN012-0021 · 2025-524062-16-00 · U1111-1325-9994

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗