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An Open-label Prospective Trial to Evaluate Functional Outcomes of OROS Methylphenidate in Children With ADHD (FOSCO)
The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder (ADHD).
Details
| Lead sponsor | Janssen Korea, Ltd., Korea |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 142 |
| Start date | 2008-09 |
| Completion | 2009-08 |
Conditions
- Attention Deficit Disorder With Hyperactivity
Interventions
- Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride
Primary outcomes
- Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12 — Baseline and Week 12
K-ARS measures the 18 symptoms based on Diagnostic and Statistical Manual of Mental Disorders-forth edition (DSM-IV 1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. - Number of Participants With Response Based on K-ARS Total Score at Week 12 — Week 12
Response is defined as at least 25 percent (%) decrease in total score of K-ARS compared to baseline. K-ARS measures the 18 symptoms based on DSM-IV (1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. - Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12 — Week 12
Remission is defined by all of the following criteria; 1) K-ARS Total score of 18 or less. 2) "Very much improved" or "Much improved" in CGI-I. K-ARS total score ranges from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. CGI-I is a 7-point scale ranging from 1 to 7, where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse, higher score indicates worsening of condition.