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FOSCO Study (Functional Outcomes Study of OROS (Osmotic-controlled Release Oral Delivery System) Methylphenidate

2014-07-24 14:10:56 | BioPortfolio

Summary

The primary objective of this study is to evaluate the effectiveness at 12 weeks of the OROS Methylphenidate for children with Attention Deficit Hyperactivity Disorder (ADHD). The treatment effectiveness will be evaluated based upon the response and remission rate which are evaluated using the K-ARS (Korean ADHD Rating Scale) and CGI (Clinical Global Impression). The secondary objectives of this study are to assess changes in overall functioning in activities of daily living and social functioning and to examine the impact of symptomatic remission on functional changes and a casual relationship between remission and functional changes after administering OROS Methylphenidate in children and adolescents with ADHD.

Description

This is an open label (all people involved know the identity of the intervention), single arm, multicenter, prospective study evaluating the effectiveness of OROS (Osmotic-controlled Release Oral delivery System) methylphenidate for 12 weeks in treating children with Attention Deficit Hyperactivity Disorder (ADHD). Recently, the final aim of the treatment of ADHD goes beyond the stage of simple response to a drug and is being narrowed down to improvement in quality of life (QOL), day living (home and school life), functional recovery and the improvement of social relationships. Treatment effectiveness will be evaluated based upon response and remission rate. The secondary objectives are to examine how treatment with OROS Methylphenidate affects overall function and to determine the impact symptomatic remission has on changes in overall function. Adverse events will be reported during the study period. From the time point of starting the first procedure related to the study until the completion of all the study procedures, the investigator will follow up on any ongoing clinically significant abnormal results until stabilized or resolved. The study will assess safety and tolerability using the Symptom Rating Scale at every visit, clinical laboratory tests at visit 1, ECG at visit 1, vital signs/height/weight at first and last visit and physical exam at visit 1. The drug effect will be assessed by evaluating the improvement of subjects' ADHD symptoms before and after the treatment using the following standardized assessment surveys: Child Health and Illness Profile (CHIP), Korean ADHD Rating Scale (K-ARS), Clinical Global Impression of Severity (CGI-S) scale, Clinical Global Impression of Improvement (CGI-I) scale, Beck Depression Inventory (BDI), Parenting Stress Index (PSI), Comprehensive Attention Test (CAT) measures and academic performance. The patients will be on once daily study medication starting at 18 mg/day in children with less than 30 kg of body weight or at 27 mg/day in children with more than 30 kg. The dose is increased approximately every 7 days in 9 mg or 18 mg increments to 54 mg/day based on the clinical judgment of the investigator

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Attention Deficit Disorder With Hyperactivity

Intervention

OROS methylphenidate hydrochloride

Status

Completed

Source

Janssen Korea, Ltd., Korea

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:56-0400

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Medical and Biotech [MESH] Definitions

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

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