Autism-Related Irritability, Schizophrenia
Conditions
Brief 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
Interventions
DRUGKarXT
Specified dose on specified days
Sponsors
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number or participants with procholinergic symptoms | Up to 54 weeks |
| Number of participants with anticholinergic symptoms | Up to 54 weeks |
| Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) | Up to 54 weeks |
| Change from baseline on the Simpson-Angus Scale (SAS) | Up to 52 weeks |
| Change from baseline on the Abnormal Involuntary Movement Scale (AIMS) | Up to 52 weeks |
| Change from baseline on the Barnes-Akathisia Rating Scale (BARS) | Up to 52 weeks |
Countries
Australia, Canada, France, Hungary, Japan, Poland, Romania, Spain, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed