Irritability associated with autistic disorder in children and adolescents with ASD
Conditions
Brief summary
Treatment-emergent adverse events (TEAEs) Safety will also be evaluated by analyses of the following: • Vital signs • Weight and body mass index (BMI) • 12-lead electrocardiograms (ECGs) • Physical examination results • Clinical laboratory tests (including urinalysis) and hormonal assessments • Columbia–Suicide Severity Rating Scale (C-SSRS) • Extrapyramidal Symptom Rating Scale Abbreviated (ESRS-A).
Detailed description
• Proportion of subjects who have at least 25% reduction in the Aberrant Behavior Checklist– Irritability (ABC-I) subscale score AND a Clinical Global Impression–Improvement (CGI-I) of irritability score of 1 (very much improved) or 2 (much improved) compared to the antecedent study baseline status at Week 52.
Interventions
DRUGPimavanserin Capsules 10 mg
DRUGPimavanserin 34 mg Capsule
DRUGPimavanserin 20 mg Capsule
Sponsors
Acadia Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events (TEAEs) Safety will also be evaluated by analyses of the following: • Vital signs • Weight and body mass index (BMI) • 12-lead electrocardiograms (ECGs) • Physical examination results • Clinical laboratory tests (including urinalysis) and hormonal assessments • Columbia–Suicide Severity Rating Scale (C-SSRS) • Extrapyramidal Symptom Rating Scale Abbreviated (ESRS-A). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of subjects who have at least 25% reduction in the Aberrant Behavior Checklist– Irritability (ABC-I) subscale score AND a Clinical Global Impression–Improvement (CGI-I) of irritability score of 1 (very much improved) or 2 (much improved) compared to the antecedent study baseline status at Week 52. | — |
Countries
France, Hungary, Italy, Poland, Spain
Outcome results
None listed