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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-09-30

Brief Summary

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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 \[Conners EC BEH-P(S)\]

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Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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Aptensio XR

Orally-administered extended release formulation of methylphenidate; once daily dosing

Intervention Type DRUG

Other Intervention Names

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Methylphenidate Extended Release

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No