RECRUITINGPhase 3INTERVENTIONAL
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
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
About This Trial
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
Who May Be Eligible (Plain English)
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
KarXT
Specified dose on specified days
Locations (20)
Local Institution - 0077
Anaheim, California, United States
Local Institution - 0058
Chino, California, United States
Local Institution - 0083
Redlands, California, United States
Local Institution - 0089
San Francisco, California, United States
Local Institution - 0032
Orlando, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Local Institution - 0103
Lawrenceville, Georgia, United States
Local Institution - 0039
Stone Mountain, Georgia, United States
Local Institution - 0044
Chicago, Illinois, United States
Local Institution - 0105
Evanston, Illinois, United States
Local Institution - 0076
Boston, Massachusetts, United States
Local Institution - 0104
Brookline, Massachusetts, United States
Local Institution - 0059
Worcester, Massachusetts, United States
Local Institution - 0061
Great Neck, New York, United States
Local Institution - 0051
Cincinnati, Ohio, United States
Local Institution - 0097
Philadelphia, Pennsylvania, United States
Local Institution - 0046
Garland, Texas, United States
Local Institution - 0090
McAllen, Texas, United States
Local Institution - 0066
Spring, Texas, United States
Local Institution - 0050
Richmond, Virginia, United States