Clinical trial NCT02677519: A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD
Official title: A 12-Month Open Label Safety Study of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR®) in Children Ages 4-5 Years Diagnosed With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
children
methylphenidate
Lead sponsor: Rhodes Pharmaceuticals, L.P.
Sponsor class: INDUSTRY
First posted: 2016-02-09
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 4 to less than 6 years inclusive at the time consent was given to participate in Prior Studies. New Subjects must be at least 4 years but less than 6 years of age when written consent is given to participate in this trial.

Primary outcomes:
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: 12 month maintenance phase
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 12 month maintenance phase
measure: Vital signs
timeFrame: 12 month maintenance phase
measure: 12-lead electrocardiogram
timeFrame: 12 month maintenance phase
Secondary outcomes:
measure: ADHD-RS-IV Preschool Version
timeFrame: 12 month maintenance phase
measure: Clinical Global Impressions-Severity Scale (CGI-S)
timeFrame: 12 month maintenance phase
measure: Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)]
timeFrame: 12 month maintenance phase
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine Inc.
state: Nevada
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Center for Psychiatry And Behavioral Medicine Inc.
name: Ann Childress, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC
name: Scott Kollins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.