An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD)

NCT01012622 | Completed Phase 4 Results

• 2 other identifiers: CR015481CON-KOR-4020
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; Methylphenidate Hydrochloride

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at 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.

  Baseline and Week 12

• Number of Participants With Response Based on K-ARS Total Score at 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.

  Week 12

• Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression - Improvement (CGI-I) Scale Score at 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.

  Week 12

Secondary Outcomes (13)

• Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12

  Baseline and Week 12

• Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12

  Baseline and Week 12

• Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12

  Baseline and Week 12

• Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12

  Baseline and Week 12

• Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12

  Baseline and Week 12

Study Arms (1)

OROS Methylphenidate Hydrochloride

EXPERIMENTAL

Drug: Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride

Interventions

Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride DRUG

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.

OROS Methylphenidate Hydrochloride

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Related Publications (1)

• 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.

  PMID: 21733227 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Research Associate
• Organization: Janssen Korea MAF, Korea

82-2-2094-4837

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 13, 2009
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 14, 2014
• Results First Posted: February 6, 2014

Record last verified: 2014-02