A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD
- Registration Number
- NCT02677519
- Lead Sponsor
- Rhodes Pharmaceuticals, L.P.
- 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 \[Conners EC BEH-P(S)\]
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 50 mg Aptensio XR Aptensio XR 50 mg methylphenidate, extended release 60 mg Aptensio XR Aptensio XR 60 mg methylphenidate, extended release 10 mg Aptensio XR Aptensio XR 10 mg methylphenidate, extended release 15 mg Aptensio XR Aptensio XR 15 mg methylphenidate, extended release 20 mg Aptensio XR Aptensio XR 20 mg methylphenidate, extended release once daily 30 mg Aptensio XR Aptensio XR 30 mg methylphenidate, extended release 40 mg Aptensio XR Aptensio XR 40 mg methylphenidate, extended release
- Primary Outcome Measures
Name Time Method Columbia Suicide Severity Rating Scale (C-SSRS) 12 month maintenance phase Standardized assessment of suicide risk
Vital signs 12 month maintenance phase blood pressure, pulse, height, weight
12-lead electrocardiogram 12 month maintenance phase Treatment-emergent adverse events (TEAEs) 12 month maintenance phase Incidence of TEAEs during maintenance phase
- Secondary Outcome Measures
Name Time Method ADHD-RS-IV Preschool Version 12 month maintenance phase Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version) to assess ADHD severity and functioning
Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)] 12 month maintenance phase Assesses behavior of preschool-aged children 2 to 6
Clinical Global Impressions-Severity Scale (CGI-S) 12 month maintenance phase This scale provides a global rating of illness severity and improvement during the study. The subject is rated relative to the clinician's past experience with other patients who have the same diagnosis. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients).
Trial Locations
- Locations (2)
Center for Psychiatry and Behavioral Medicine Inc.
🇺🇸Las Vegas, Nevada, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States