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

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ClinicalTrials.gov Identifier: NCT01012622
Recruitment Status : Completed
First Posted : November 13, 2009
Results First Posted : February 6, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Disorder With Hyperactivity
Intervention Drug: Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride
Enrollment 142
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Period Title: Overall Study
Started 142
Completed 111
Not Completed 31
Reason Not Completed
Withdrawal by Subject             6
Lost to Follow-up             5
Adverse Event             7
non-compliance with the drug             9
Other             1
screening failure             1
withdrawal of consent by a parent             2
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Baseline Participants 136
Hide Baseline Analysis Population Description
Safety Population included all participants who took at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants
8.4  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants
Female
24
  17.6%
Male
112
  82.4%
1.Primary Outcome
Title Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population included participants who received the study drug at least once and had the primary efficacy endpoint data available
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 134
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 33.37  (8.67)
Change at Week 12 -20.43  (10.42)
2.Primary Outcome
Title Number of Participants With Response Based on K-ARS Total Score at Week 12
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 127
Measure Type: Number
Unit of Measure: participants
118
3.Primary Outcome
Title Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression – Improvement (CGI-I) Scale Score at Week 12
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 127
Measure Type: Number
Unit of Measure: participants
99
4.Secondary Outcome
Title Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12
Hide Description CHIP was designed to assess the physical, psychological health conditions and functional well-being of children. The instrument has sub-domains such satisfaction (11 items) ranges from 0 to 44, stability (22 items) ranges from 0 to 88, elasticity (19 items) ranges from 0 to 76, risk aversion (14 items) ranges from 0 to 56, achievement (10 items) ranges from 0 to 40. Good health is in the range from 44 to 56 points for all sub-domains. A score of 43 or below indicates poor health in that domain. A score of 57 or higher indicates excellent health. The total score is an average of the scores for the 5 domains and ranges from 0 to 304. Higher total score indicates better health.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who took study drug at least once and had primary efficacy endpoint data available. Last Observation Carried Forward (LOCF) method was used. "n" signifies participants who were evaluated for each specified category for this measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 134
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total Score:Baseline (n=126) 207.85  (26.62)
Total Score:Change at Week 12 (n=126) 18.08  (22.54)
Satisfaction:Baseline (n=132) 26.17  (7.20)
Satisfaction:Change at Week 12 (n=132) 2.27  (5.89)
Stability:Baseline (n=129) 82.13  (11.18)
Stability:Change at Week 12 (n=129) 4.47  (10.87)
Elasticity:Baseline (n=132) 38.30  (8.22)
Elasticity:Change at Week 12 (n=132) 2.53  (7.10)
Risk aversion:Baseline (n=132) 40.67  (7.91)
Risk aversion:Change at Week 12 (n=132) 5.73  (7.27)
Achievement:Baseline (n=133) 21.00  (6.16)
Achievement:Change at Week 12 (n=133) 2.45  (5.07)
5.Secondary Outcome
Title Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
Hide Description CAT was developed to properly reflect brain function in childhood. It provided measurement of simple visual selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 118
Mean (Standard Deviation)
Unit of Measure: units on a scale
Omission:Baseline 8.79  (15.77)
Omission:Change at Week 12 -4.53  (17.94)
False alarm:Baseline 17.42  (18.48)
False alarm:Change at Week 12 -5.03  (13.43)
Response mean:Baseline 501.32  (130.80)
Response mean:Change at Week 12 -37.41  (110.34)
Response:Baseline 201.05  (105.78)
Response:Change at Week 12 -48.36  (111.02)
6.Secondary Outcome
Title Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
Hide Description CAT was developed to properly reflect brain function in childhood. It provided measurement of simple auditory selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 118
Mean (Standard Deviation)
Unit of Measure: units on a scale
Omission:Baseline 10.31  (16.52)
Omission:Change at Week 12 -6.27  (15.88)
False alarm:Baseline 12.07  (14.41)
False alarm:Change at Week 12 -3.61  (11.86)
Response mean:Baseline 623.95  (188.38)
Response mean:Change at Week 12 -55.34  (155.36)
Response:Baseline 265.69  (108.76)
Response:Change at Week 12 -63.76  (114.15)
7.Secondary Outcome
Title Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
Hide Description CAT was developed to properly reflect brain function in childhood. It provided measurement of simple inhibition-sustained attention in terms of omission(number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 119
Mean (Standard Deviation)
Unit of Measure: units on a scale
Omission:Baseline 35.78  (46.91)
Omission:Change at Week 12 -20.39  (45.40)
False alarm:Baseline 27.73  (15.58)
False alarm:Change at Week 12 -7.54  (14.19)
Response mean:Baseline 576.55  (147.13)
Response mean:Change at Week 12 -34.44  (140.43)
Response:Baseline 273.78  (121.94)
Response:Change at Week 12 -66.85  (127.13)
8.Secondary Outcome
Title Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
Hide Description CAT was developed to properly reflect brain function in childhood. It provided measurement of simple interference-selective attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 119
Mean (Standard Deviation)
Unit of Measure: units on a scale
Omission:Baseline 20.39  (24.44)
Omission:Change at Week 12 -10.83  (20.10)
False alarm:Baseline 26.03  (18.30)
False alarm:Change at Week 12 -6.14  (16.75)
Response mean:Baseline 648.48  (171.84)
Response mean:Change at Week 12 -54.35  (134.26)
Response:Baseline 276.74  (156.70)
Response:Change at Week 12 -72.18  (148.01)
9.Secondary Outcome
Title Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12
Hide Description CAT was developed to properly reflect brain function in childhood. It provided measurement of simple divided attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Omission:Baseline 16.05  (9.69)
Omission:Change at Week 12 -4.07  (10.18)
False alarm:Baseline 16.03  (12.36)
False alarm:Change at Week 12 -4.73  (9.44)
Response mean:Baseline 749.01  (196.66)
Response mean:Change at Week 12 -27.14  (186.70)
Response:Baseline 349.60  (130.41)
Response:Change at Week 12 -43.90  (118.84)
10.Secondary Outcome
Title Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12
Hide Description CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the forward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: correct responses
Baseline:Number of correct responses 5.76  (2.34)
Change at Week 12:Number of correct responses 0.63  (2.56)
Baseline:Width of space 4.46  (1.53)
Change at Week 12:Width of space 0.25  (1.78)
11.Secondary Outcome
Title Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12
Hide Description CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the backward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: correct responses
Baseline:Number of correct responses 4.22  (2.79)
Change at Week 12:Number of correct responses 1.86  (3.02)
Baseline:Spatial span 3.63  (2.06)
Change at Week 12:Spatial span 1.24  (1.98)
12.Secondary Outcome
Title Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12
Hide Description APRS scale measures four factors in elementary school children such as learning ability, academic performance, impulse control, and social withdrawal. In particular, it is excellent in assessing drug effect on the academic performance not measured by other scales. Score ranges from 19 to 95, higher score means better academic performance.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 55.46  (12.77)
Change at Week 12 7.40  (9.86)
13.Secondary Outcome
Title Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12
Hide Description Beck Depression Inventory (BDI) consisted of 21 items for measuring the subjective severity of depression and emotional, cognitive, motivational, physiological symptoms of depression. Each question has a set of 4 possible answer choices, ranging in intensity, each answer being scored on a scale value of 0 (no symptom) to 3 (the most severe symptom). Accordingly, the total score ranges from 0 (no symptom) to 63 (the most severe symptom) for 21 questions.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 127
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 11.69  (7.79)
Change at Week 12 -1.89  (6.59)
14.Secondary Outcome
Title Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12
Hide Description Parenting Stress Index (PSI) was designed to assess parent or guardian child-rearing stress index on a 5-rating scale from ”never” to “very truly”. Out of 30 items, 20 items are scored, being consisted of 8 child characteristics-related stress items; 9 parent-child interaction-related stress items; and 3 achievement expectation-related stress items. A possible total score ranges from 20 to 100; Increase in score indicates higher stress perceived by the parent.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 58.20  (9.33)
Change at Week 12 -5.25  (9.01)
15.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12
Hide Description The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher change scores indicate worsening.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 134
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.14  (0.90)
Change at Week 12 -2.51  (1.36)
16.Secondary Outcome
Title Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12
Hide Description The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Improved very much, Improved much and Improved a little are defined as improvement and No change, Aggravated a little, Aggravated much and Aggravated very much were defined as aggravation.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description:
OROS methylphenidate hydrochloride (HCL) was 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 was 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.
Overall Number of Participants Analyzed 129
Measure Type: Number
Unit of Measure: participants
Improvement 122
Aggravation 7
Time Frame From signing of informed consent form until 30 days from the completion of assessments after the administration of the last study medication (follow-up) or the point of time of dropout
Adverse Event Reporting Description Safety Population included all participants who took at least one dose of study drug.
 
Arm/Group Title Osmotic Release Oral System (OROS) Methylphenidate HCL
Hide Arm/Group Description OROS methylphenidate hydrochloride (HCL) was 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 was 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.
All-Cause Mortality
Osmotic Release Oral System (OROS) Methylphenidate HCL
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Osmotic Release Oral System (OROS) Methylphenidate HCL
Affected / at Risk (%)
Total   0/136 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Osmotic Release Oral System (OROS) Methylphenidate HCL
Affected / at Risk (%)
Total   112/136 (82.35%) 
Congenital, familial and genetic disorders   
Ear malformation * 1  1/136 (0.74%) 
Ventricular septal defect * 1  1/136 (0.74%) 
Ear and labyrinth disorders   
Deafness neurosensory * 1  1/136 (0.74%) 
Gastrointestinal disorders   
Abdominal pain * 1  43/136 (31.62%) 
Nausea * 1  17/136 (12.50%) 
Dyspepsia * 1  3/136 (2.21%) 
Vomiting * 1  3/136 (2.21%) 
Constipation * 1  1/136 (0.74%) 
Stomatitis * 1  1/136 (0.74%) 
General disorders   
Crying * 1  1/136 (0.74%) 
Inflammation * 1  1/136 (0.74%) 
Irritability * 1  1/136 (0.74%) 
Infections and infestations   
Nasopharyngitis * 1  11/136 (8.09%) 
Rhinitis * 1  3/136 (2.21%) 
Upper respiratory tract infection * 1  2/136 (1.47%) 
Gastroenteritis * 1  1/136 (0.74%) 
Otitis media * 1  1/136 (0.74%) 
Otitis media chronic * 1  1/136 (0.74%) 
Urinary tract infection * 1  1/136 (0.74%) 
Varicella * 1  1/136 (0.74%) 
Injury, poisoning and procedural complications   
Scratch * 1  1/136 (0.74%) 
Investigations   
Weight decreased * 1  4/136 (2.94%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  82/136 (60.29%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/136 (0.74%) 
Nervous system disorders   
Headache * 1  41/136 (30.15%) 
Somnolence * 1  32/136 (23.53%) 
Dizziness * 1  19/136 (13.97%) 
Movement disorder * 1  3/136 (2.21%) 
Hypersomnia * 1  1/136 (0.74%) 
Tremor * 1  1/136 (0.74%) 
Psychiatric disorders   
Insomnia * 1  66/136 (48.53%) 
Anxiety * 1  51/136 (37.50%) 
Decreased interest * 1  41/136 (30.15%) 
Communication disorder * 1  37/136 (27.21%) 
Onychophagia * 1  37/136 (27.21%) 
Daydreaming * 1  31/136 (22.79%) 
Nightmare * 1  21/136 (15.44%) 
Depressed mood * 1  18/136 (13.24%) 
Tic * 1  11/136 (8.09%) 
Nervousness * 1  9/136 (6.62%) 
Sleep disorder * 1  4/136 (2.94%) 
Depression * 1  3/136 (2.21%) 
Hostility * 1  3/136 (2.21%) 
Agitation * 1  2/136 (1.47%) 
Euphoric mood * 1  2/136 (1.47%) 
Acute stress disorder * 1  1/136 (0.74%) 
Logorrhoea * 1  1/136 (0.74%) 
Renal and urinary disorders   
Enuresis * 1  2/136 (1.47%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/136 (0.74%) 
Sneezing * 1  1/136 (0.74%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  4/136 (2.94%) 
Dermatitis atopic * 1  3/136 (2.21%) 
Dermatitis contact * 1  1/136 (0.74%) 
Hyperhidrosis * 1  1/136 (0.74%) 
Rash * 1  1/136 (0.74%) 
Excessive eye blinking * 1  5/136 (3.68%) 
Eye pain * 1  1/136 (0.74%) 
Surgical and medical procedures   
Depilation * 1  1/136 (0.74%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, V. 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal Investigator cannot provide any trial related information to external parties’ without mutual agreement with the sponsor. This is valid even after the contract is cancelled.
Results Point of Contact
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Name/Title: Clinical Research Associate
Organization: Janssen Korea MAF, Korea
Phone: 82-2-2094-4837
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Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01012622     History of Changes
Other Study ID Numbers: CR015481
CON-KOR-4020
First Submitted: November 5, 2009
First Posted: November 13, 2009
Results First Submitted: April 30, 2013
Results First Posted: February 6, 2014
Last Update Posted: March 14, 2014