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NCT Number: NCT07424404

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

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

Recruiting

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0084, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KarXT

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with treatment emergent adverse events (TEAEs)

    Time frame: Up to 54 weeks

  2. Number of participants with adverse events of special interest (AESIs)

    Time frame: Up to 54 weeks

  3. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 54 weeks

Secondary outcomes

  1. Number or participants with procholinergic symptoms

    Time frame: Up to 54 weeks

  2. Number of participants with anticholinergic symptoms

    Time frame: Up to 54 weeks

  3. Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to 54 weeks

  4. Change from baseline on the Simpson-Angus Scale (SAS)

    Time frame: Up to 52 weeks

  5. Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)

    Time frame: Up to 52 weeks

  6. Change from baseline on the Barnes-Akathisia Rating Scale (BARS)

    Time frame: Up to 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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