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)
Overview
- Phase
- Phase 4
- Intervention
- Aptensio XR
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Sponsor
- Rhodes Pharmaceuticals, L.P.
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Columbia Suicide Severity Rating Scale (C-SSRS)
- Last Updated
- 9 years ago
Overview
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)]
Investigators
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.
Exclusion Criteria
- Not provided
Arms & Interventions
10 mg Aptensio XR
10 mg methylphenidate, extended release
Intervention: Aptensio XR
15 mg Aptensio XR
15 mg methylphenidate, extended release
Intervention: Aptensio XR
20 mg Aptensio XR
20 mg methylphenidate, extended release once daily
Intervention: Aptensio XR
30 mg Aptensio XR
30 mg methylphenidate, extended release
Intervention: Aptensio XR
40 mg Aptensio XR
40 mg methylphenidate, extended release
Intervention: Aptensio XR
50 mg Aptensio XR
50 mg methylphenidate, extended release
Intervention: Aptensio XR
60 mg Aptensio XR
60 mg methylphenidate, extended release
Intervention: Aptensio XR
Outcomes
Primary Outcomes
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 12 month maintenance phase
Standardized assessment of suicide risk
Vital signs
Time Frame: 12 month maintenance phase
blood pressure, pulse, height, weight
12-lead electrocardiogram
Time Frame: 12 month maintenance phase
Treatment-emergent adverse events (TEAEs)
Time Frame: 12 month maintenance phase
Incidence of TEAEs during maintenance phase
Secondary Outcomes
- ADHD-RS-IV Preschool Version(12 month maintenance phase)
- Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)](12 month maintenance phase)
- Clinical Global Impressions-Severity Scale (CGI-S)(12 month maintenance phase)