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Long-term Safety of KarXT for Schizophrenia and Autism-Related Irritability

This study is looking at the long-term safety of two medicines, KarXT and KarX-EC, for teenagers and children aged 5 to 17. KarXT is for schizophrenia, and KarX-EC is for irritability related to autism. You can join this study if you have already completed a previous study (CN0120020, CN0120044, or CN0120045) without serious side effects. The main goal is to see how many participants experience side effects (adverse events) over time, up to 54 weeks. The current recruitment status is unclear, and the study plans to enroll about 400 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to evaluate long-term safety and tolerability.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 54 weeks to monitor for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE3Ages 5–17InterventionalTreatment
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
~400 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:KarXT

At a glance

Recruiting sites
15 of 91 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment emergent adverse events (TEAEs)
Measured over Up to 54 weeks
+2 more outcomes measured

Conditions

Schizophrenia
Autism-Related Irritability

Explore related trials

Autism-Related IrritabilitySchizophrenia

Where it's being run

91 sites across 45 states
California10
Texas6
Florida5
Romania5
Spain4
Georgia3
Massachusetts3
New York3

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Number of participants with treatment emergent adverse events (TEAEs)Up to 54 weeks
  • Number of participants with adverse events of special interest (AESIs)Up to 54 weeks
  • Number of participants with serious adverse events (SAEs)Up to 54 weeks