Long-term safety of KarXT and KarX-EC in adolescents with schizophrenia or autism-related irritability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 extension enrolls adolescents who completed the double-blind treatment periods of the parent trials (CN0120020, CN0120044, or CN0120045) to continue on KarXT or KarX-EC and be followed for long-term safety and tolerability. Participants will be monitored regularly for adverse events, vital signs, ECG findings, and psychiatric status. Enrollment excludes those with clinically significant abnormal physical/ECG findings or who are judged to be at high risk of violent behavior or suicide. The goal is to gather extended safety data to inform ongoing use in adolescent populations.

Why it matters

Who can join: the full rules

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 opinion of the investigator, may indicate an unacceptable safety risk.
* De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).

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, or ECG at the end of treatment visit of Study CN0120020, CN0120044 or CN00120045 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.

Where it's running

• Advanced Research Center Inc.
  Anaheim, California, United States Recruiting
• Inland Psychiatric Medical Group.
  Chino, California, United States Recruiting
• Proscience Research Group
  Culver City, California, United States Recruiting
• UCSF Neurosciences Clinical Research Unit (NCRU)
  San Francisco, California, United States Recruiting
• Research Centers of America - Hollywood - CenExel - PPDS
  Hollywood, Florida, United States Recruiting
• Apg Research, Llc
  Orlando, Florida, United States Recruiting

+55 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.