The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
176
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Time frame: Week 8
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8
Time frame: Week 8
Number of Participants With ABC-I response at Week 8
ABC-I response is determined by ≥ 25% reduction in ABC-I score from baseline.
Time frame: Week 8
Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8
Time frame: Week 8
Change From Baseline on the Stereotypic Behavior Subscale at Week 8
Time frame: Week 8
Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8
Time frame: Week 8
Change From Baseline on the Inappropriate Speech Subscale at Week 8
Time frame: Week 8
Clinical Global Impression-Improvement (CGI-I) Score at Week 8
Time frame: Week 8
Number of Participants With Procholinergic Symptoms
Time frame: Up to approximately 12 weeks
Number of Participants With Anticholinergic Symptoms
Time frame: Up to approximately 12 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Local Institution - 0062
Phoenix, Arizona, United States
Local Institution - 0013
Glendale, California, United States
Local Institution - 0117
Los Angeles, California, United States
Local Institution - 0126
Orange, California, United States
Local Institution - 0132
San Diego, California, United States
Local Institution - 0115
San Juan Capistrano, California, United States
Local Institution - 0116
San Rafael, California, United States
Local Institution - 0130
New Haven, Connecticut, United States
Local Institution - 0080
Orlando, Florida, United States
Local Institution - 0072
Decatur, Georgia, United States
...and 53 more locations
Time frame: Up to approximately 12 weeks
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately 12 weeks
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to approximately 12 weeks
Number of Participants With AEs Leading to Discontinuation of Study Intervention
Time frame: Up to approximately 8 weeks