Phase 3 Evaluation of KarXT and KarXT+KarX-EC in Schizophrenia and Autism-Related Irritability in Youth, Respectively

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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011250071

Enrollment

400

Registered

2026-03-24

Start date

2026-05-11

Completion date

Unknown

Last updated

2026-05-25

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

Conditions

Schizophrenia, ASD Irritability

Interventions

Adolescent Schizophrenia Study Arm:KarXT (Specified dose on specified days) /ASD Irritability Study Arm:KarXT (Specified dose on specified days)

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Occurrence of TEAEs, AESIs, and SAEs during the treatment and safety follow-up periods.	—

Secondary

Measure	Time frame
-Occurrence of procholinergic and anticholinergic symptoms during the treatment period. -Suicidal ideation and behavior assessed using the C-SSRS during the treatment and safety follow-up periods. -CFB on the SAS, AIMS, and BARS by visit during the treatment period.	—

Countries

CANADA, FRANCE, GERMANY, HUNGARY, Japan, POLAND, ROMANIA, SPAIN, UNITED STATES

Contacts

Public ContactRajiv Radhakrishnan

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 30, 2026