A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD

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 \[Conners EC BEH-P(S)\]

Timeline

Start

2016-09

Primary completion

2017-04

Completion

2017-09

Publications

• Childress AC, Foehl HC, Newcorn JH, Faraone SV, Levinson B, Adjei AL. Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):80-92. doi: 10.1016/j.jaac.2021.03.019. Epub 2021 Apr 20.

Drugs

Indications