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Clinical Trials in the EU / 2025-524062-16-00
Authorised, recruiting Phase III

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

2025-524062-16-00 · tracked via the Priya Life Science EU tracker
Sponsor
Bristol-Myers Squibb Services Unlimited Company
Sponsor type
Pharmaceutical company
Therapeutic area
Nervous System Diseases
Decision date
29/05/2026
Enrollment target
40
Sites
Romania

Condition studied

Schizophrenia and Autism Spectrum Disorder (ASD)

Investigational medicinal product(s)

KarXTKarX-EC

Eligibility

Age group
0-17 years
Sex
Female, Male

Primary endpoint

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.

Endpoint detail

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.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524062-16-00 on CTIS ↗ ← All trials in the EU