Summary

Eligibility
for people ages 5-17 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official 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

Keywords

Schizophrenia, Autism-Related Irritability, KarXT, Administration of KarXT for Schizophrenia, Administration of KarXT for Autism-related Irritability

Eligibility

You can join if…

Open to people ages 5-17

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Local Institution - 0153 not yet accepting patients
    Los Angeles California 90095 United States
  • Local Institution - 0024 not yet accepting patients
    Culver City California 90230 United States
  • Local Institution - 0162 not yet accepting patients
    Glendale California 91203 United States
  • Advanced Research Center Inc. accepting new patients
    Anaheim California 92805 United States
  • Local Institution - 0159 not yet accepting patients
    Anaheim California 92805 United States
  • Inland Psychiatric Medical Group. accepting new patients
    Chino California 91710 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT07424404
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated