Attention Deficit Disorder With Hyperactivity Clinical Trial
— EF004Official 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)
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)]
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | September 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 6 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
United States | Center for Psychiatry and Behavioral Medicine Inc. | Las Vegas | Nevada |
Lead Sponsor | Collaborator |
---|---|
Rhodes Pharmaceuticals, L.P. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment-emergent adverse events (TEAEs) | Incidence of TEAEs during maintenance phase | 12 month maintenance phase | Yes |
Primary | Columbia Suicide Severity Rating Scale (C-SSRS) | Standardized assessment of suicide risk | 12 month maintenance phase | Yes |
Primary | Vital signs | blood pressure, pulse, height, weight | 12 month maintenance phase | Yes |
Primary | 12-lead electrocardiogram | 12 month maintenance phase | Yes | |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)] | Assesses behavior of preschool-aged children 2 to 6 | 12 month maintenance phase | No |
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