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

Study 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)]

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)

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Drug: Aptensio XR


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mg Aptensio XR<br>10 mg methylphenidate, extended release | Drug: Aptensio XR<br>* Orally-administered extended release formulation of methylphenidate; once daily dosing<br>* Other names: Methylphenidate Extended Release;|
| Experimental: 15 mg Aptensio XR<br>15 mg methylphenidate, extended release | Drug: Aptensio XR<br>* Orally-administered extended release formulation of methylphenidate; once daily dosing<br>* Other names: Methylphenidate Extended Release;|
| Experimental: 20 mg Aptensio XR<br>20 mg methylphenidate, extended release once daily | Drug: Aptensio XR<br>* Orally-administered extended release formulation of methylphenidate; once daily dosing<br>* Other names: Methylphenidate Extended Release;|
| Experimental: 30 mg Aptensio XR<br>30 mg methylphenidate, extended release | Drug: Aptensio XR<br>* Orally-administered extended release formulation of methylphenidate; once daily dosing<br>* Other names: Methylphenidate Extended Release;|
| Experimental: 40 mg Aptensio XR<br>40 mg methylphenidate, extended release | Drug: Aptensio XR<br>* Orally-administered extended release formulation of methylphenidate; once daily dosing<br>* Other names: Methylphenidate Extended Release;|
| Experimental: 50 mg Aptensio XR<br>50 mg methylphenidate, extended release | Drug: Aptensio XR<br>* Orally-administered extended release formulation of methylphenidate; once daily dosing<br>* Other names: Methylphenidate Extended Release;|
| Experimental: 60 mg Aptensio XR<br>60 mg methylphenidate, extended release | Drug: Aptensio XR<br>* Orally-administered extended release formulation of methylphenidate; once daily dosing<br>* Other names: Methylphenidate Extended Release;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events (TEAEs) | Incidence of TEAEs during maintenance phase | 12 month maintenance phase | 
| Columbia Suicide Severity Rating Scale (C-SSRS) | Standardized assessment of suicide risk | 12 month maintenance phase | 
| Vital signs | blood pressure, pulse, height, weight | 12 month maintenance phase | 
| 12-lead electrocardiogram |  | 12 month maintenance phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-RS-IV Preschool Version | Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version) to assess ADHD severity and functioning | 12 month maintenance phase | 
| Clinical Global Impressions-Severity Scale (CGI-S) | 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). | 12 month maintenance phase | 
| Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)] | Assesses behavior of preschool-aged children 2 to 6 | 12 month maintenance phase | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, children, methylphenidate