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
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.
- Who it may be relevant to
- Registry conditions: Schizophrenia, Autism-Related Irritability. Basic parameters: 5 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, Argentina, Australia, Canada, France +6
- 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, 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
Overview
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
Interventions
- Drug KarXT
Specified dose on specified days
Primary outcome measures
- Number of participants with treatment emergent adverse events (TEAEs) [Time frame: Up to 54 weeks]
- Number of participants with adverse events of special interest (AESIs) [Time frame: Up to 54 weeks]
- Number of participants with serious adverse events (SAEs) [Time frame: Up to 54 weeks]
Secondary outcome measures (6)
- Number or participants with procholinergic symptoms [Time frame: Up to 54 weeks]
- Number of participants with anticholinergic symptoms [Time frame: Up to 54 weeks]
- Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: Up to 54 weeks]
- Change from baseline on the Simpson-Angus Scale (SAS) [Time frame: Up to 52 weeks]
- Change from baseline on the Abnormal Involuntary Movement Scale (AIMS) [Time frame: Up to 52 weeks]
- Change from baseline on the Barnes-Akathisia Rating Scale (BARS) [Time frame: Up to 52 weeks]
Eligibility criteria
Inclusion criteria
\- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 51 centers
- 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
- … and 43 more centers
Japan · 7 centers
- 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
Poland · 7 centers
- Local Institution - 0128 — Poznan
- Local Institution - 0125 — Wroclaw
- … and 5 more centers
Romania · 6 centers
Center list to be confirmed — check the primary protocol.
Argentina · 5 centers
- 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
Australia · 4 centers
- Local Institution - 0107 — Westmead
- Local Institution - 0106 — Brisbane
- Local Institution - 0108 — Melbourne
- Local Institution - 0109 — Melbourne
Canada · 4 centers
- Local Institution - 0111 — Edmonton
- Local Institution - 0110 — Kingston
- Local Institution - 0113 — Toronto
- Local Institution - 0112 — Montreal
Spain · 4 centers
Center list to be confirmed — check the primary protocol.
France · 3 centers
- Local Institution - 0118 — Bordeaux
- Local Institution - 0120 — Bron
- Local Institution - 0119 — Paris
Hungary · 3 centers
- Local Institution - 0129 — Budapest
- Local Institution - 0130 — Gyula
- Local Institution - 0131 — Szeged
Germany · 1 center
- Local Institution - 0121 — Gdansk
Identifiers
NCT: NCT07424404 · CN012-0021 · 2025-524062-16-00 · U1111-1325-9994