Clinical trial NCT01012622: An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: An Open-label Prospective Trial to Evaluate Functional Outcomes of OROS Methylphenidate in Children With ADHD (FOSCO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Hyperactivity Disorder
Methylphenidate Hydrochloride
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 142
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: This is an open-label (all people involved know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), prospective study (study following participants forward in time) to evaluate the efficacy and safety of OROS methylphenidate in participants with ADHD (behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity). The study duration will be of 12 weeks per participant, which is divided into 2 parts Screening (within 14 days before study commences on Day -1) and treatment (8 weeks and will include titration period \[from the initiation of the study treatment to determination of the individual's maintenance dose\] and maintenance period \[at least 4 weeks after determination of maintenance dose\]). Participants will receive initial dose depending on their body weight. OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose will be increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability. Efficacy will be evaluated by Korean Version, ADHD Rating Scale (K-ARS) total score and Clinical Global Impression)-Severity / Impression rating scale CGI-S/I. Participants safety will be monitored throughout the trial.

Eligibility criteria: Inclusion Criteria:

* Participants voluntarily provided informed consent to participate in the study
* Participants with written informed consent to participate in the study voluntarily by caregivers/legal representatives
* Participants who were capable to follow the study visit schedule well and their parents/caregivers who were willing to complete the assessments specified in the protocol and were capable to complete them
* Participant and his/her parent/guardian able to understand the study participation and to request withdrawal from the study voluntarily at any time
* Participants who were satisfied in diagnosis of Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) Attention Deficit Hyperactivity Disorder (ADHD) and determined to require drug therapy

Exclusion Criteria:

* Participants who have known hypersensitivity (altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen) to methylphenidate HCL
* Participants who have significant suicidal ideation
* Participants with mental retardation
* Participants who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy
* Participants who have abnormalities in the Electrocardiography (ECG) or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology

Primary outcomes:
measure: Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants With Response Based on K-ARS Total Score at Week 12
timeFrame: Week 12
measure: Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12
timeFrame: Baseline and Week 12
measure: Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Kim BN, Cummins TD, Kim JW, Bellgrove MA, Hong SB, Song SH, Shin MS, Cho SC, Kim JH, Son JW, Shin YM, Chung US, Han DH. Val/Val genotype of brain-derived neurotrophic factor (BDNF) Val(6)(6)Met polymorphism is associated with a better response to OROS-MPH in Korean ADHD children. Int J Neuropsychopharmacol. 2011 Nov;14(10):1399-410. doi: 10.1017/S146114571100099X. Epub 2011 Jun 28.