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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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524062-16-00
Enrollment
40
Registered
2026-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia and Autism Spectrum Disorder (ASD)

Brief summary

Occurrence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) during the treatment and safety follow-up periods.

Detailed description

Occurrence of procholinergic and anticholinergic symptoms during the treatment period., Suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) during the treatment and safety follow-up periods., Change from baseline (CFB) on the Simpson-Angus Scale (SAS), Barnes-Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS) by visit during the treatment period.

Interventions

DRUGKarXT
DRUGKarX-EC

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Occurrence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) during the treatment and safety follow-up periods.—

Secondary

MeasureTime frame
Occurrence of procholinergic and anticholinergic symptoms during the treatment period., Suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) during the treatment and safety follow-up periods., Change from baseline (CFB) on the Simpson-Angus Scale (SAS), Barnes-Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS) by visit during the treatment period.—

Outcome results

None listed

Source: EU CTIS · Data processed: May 30, 2026