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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 5 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Administration of KarXT for Schizophrenia
  • Drug: KarXT
    Specified dose on specified days
Experimental
Administration of KarXT for Autism-related Irritability
  • Drug: KarXT
    Specified dose on specified days

Recruiting Locations

Apg Research, Llc
Orlando, Florida 32803
Contact:
Morteza Nadjafi, Site 0032
407-423-7149

Atlanta Center for Medical Research
Atlanta, Georgia 30331
Contact:
Elyssa Barron, Site 0057
404-881-5800

Salveo Integrative Health - Lawrenceville
Lawrenceville, Georgia 30046
Contact:
Shahzad Hashmi, Site 0103

EmVenio Research Center - Prime Healthcare
Chicago, Illinois 60622
Contact:
Mitchell Glaser, Site 0044
773-620-2995

University of Cincinnati Cancer Institute
Cincinnati, Ohio 45219
Contact:
Melissa DelBello, Site 0051

More Details

Status
Recruiting
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.