Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD, children, methylphenidate
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 \[Conners EC BEH-P(S)\]
Interventions
DRUGAptensio XR
Orally-administered extended release formulation of methylphenidate; once daily dosing
Sponsors
Rhodes Pharmaceuticals, L.P.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) | 12 month maintenance phase | Incidence of TEAEs during maintenance phase |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)] | 12 month maintenance phase | Assesses behavior of preschool-aged children 2 to 6 |
| 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 |
Countries
United States
Contacts
Primary ContactAkwete Adjei, PhD
Outcome results
None listed