Irritability Associated With Autism Spectrum Disorder
Conditions
Keywords
Autism Spectrum Disorder
Brief summary
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Interventions
DRUGKarXT
Specified dose on specified days
DRUGKarX-EC
Specified dose on specified days
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability. * Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).
Exclusion criteria
* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD). * Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable. * Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results. * Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 | Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8 | Week 8 | — |
| Number of Participants With ABC-I response at Week 8 | Week 8 | ABC-I response is determined by ≥ 25% reduction in ABC-I score from baseline. |
| Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8 | Week 8 | — |
| Change From Baseline on the Stereotypic Behavior Subscale at Week 8 | Week 8 | — |
| Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8 | Week 8 | — |
| Change From Baseline on the Inappropriate Speech Subscale at Week 8 | Week 8 | — |
| Clinical Global Impression-Improvement (CGI-I) Score at Week 8 | Week 8 | — |
| Number of Participants With Procholinergic Symptoms | Up to approximately 12 weeks | — |
| Number of Participants With Anticholinergic Symptoms | Up to approximately 12 weeks | — |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 12 weeks | — |
| Number of Participants With Serious Adverse Events (SAEs) | Up to approximately 12 weeks | — |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Up to approximately 12 weeks | — |
| Number of Participants With AEs Leading to Discontinuation of Study Intervention | Up to approximately 8 weeks | — |
Countries
France, Germany, Hungary, India, Japan, Poland, Puerto Rico, 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