A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD
Status:
Unknown status
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of
methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children aged 4-5
years who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD).
Safety and tolerability will be evaluated by assessing treatment-emergent adverse events
(TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory The
primary objective of this study is to evaluate the long-term (12-month) safety and
tolerability of Aptensio XR® in children aged 4 to less than 6 years who have been diagnosed
with ADHD.
Safety and tolerability will be evaluated by assessing treatment-emergent adverse events
(TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory values
and Columbia Suicide Severity Rating Scale (C-SSRS). Disturbances in sleep (quantity and
quality) patterns will also be assessed using the Child Sleep Habits Questionnaire (CSHQ).
Secondary objectives include assessment of long-term efficacy of Aptensio XR®.
Secondary measures include:
- Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale
Preschool Version (ADHD-RS-IV Preschool Version)
- Clinical Global Impressions-Severity Scale (CGI-S )
- Connors Early Childhood Behavior-Parent Short form [Conners EC BEH-P(S)]