Trial Outcomes & Findings for The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00758160)
NCT ID: NCT00758160
Last Updated: 2014-04-08
Results Overview
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.
COMPLETED
PHASE4
296 participants
Baseline and Week 2
2014-04-08
Participant Flow
Participant milestones
| Measure |
OROS MPH
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Overall Study
STARTED
|
296
|
|
Overall Study
COMPLETED
|
230
|
|
Overall Study
NOT COMPLETED
|
66
|
Reasons for withdrawal
| Measure |
OROS MPH
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
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|---|---|
|
Overall Study
No Longer Requires Study Medication
|
4
|
|
Overall Study
Administration Problems
|
3
|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Lack of Efficacy
|
10
|
|
Overall Study
Lost to Follow-up
|
14
|
|
Overall Study
Protocol Violation
|
12
|
|
Overall Study
Withdrawal by Subject
|
8
|
Baseline Characteristics
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
OROS MPH
n=296 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
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|---|---|
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Age, Continuous
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9.5 Years
STANDARD_DEVIATION 2.4 • n=5 Participants
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|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
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Sex: Female, Male
Male
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247 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 2Population: Intent-to-treat (ITT) analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.
Outcome measures
| Measure |
OROS MPH
n=296 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Baseline: Hyperactivity (n = 293)
|
1.4 Units on a scale
Standard Deviation 0.7
|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Baseline: Oppositional (n = 296)
|
1.3 Units on a scale
Standard Deviation 0.7
|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Change at Week 2: Inattention (n = 293)
|
-0.4 Units on a scale
Standard Deviation 0.5
|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Change at Week 2: Hyperactivity (n = 293)
|
-0.3 Units on a scale
Standard Deviation 0.5
|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Change at Week 2: Oppositional (n = 296)
|
-0.3 Units on a scale
Standard Deviation 0.5
|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Baseline: Inattention (n = 293)
|
1.7 Units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.
Outcome measures
| Measure |
OROS MPH
n=296 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
Change at Week 4: Inattention (n = 293)
|
-0.4 Units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
Change at Week 4: Hyperactivity (n = 293)
|
-0.3 Units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
Change at Week 4: Oppositional (n = 296)
|
-0.3 Units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.
Outcome measures
| Measure |
OROS MPH
n=296 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
Change at Week 8: Inattention (n = 293)
|
-0.5 Units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
Change at Week 8: Hyperactivity (n = 293)
|
-0.4 Units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
Change at Week 8: Oppositional (n = 296)
|
-0.4 Units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.
Outcome measures
| Measure |
OROS MPH
n=275 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
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|---|---|
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Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
Baseline: Mother Assessment (n = 275)
|
1.9 Units on a scale
Standard Deviation 0.6
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|
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
Baseline: Father Assessment (n = 216)
|
1.7 Units on a scale
Standard Deviation 0.4
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|
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
Change at Week 4: Mother Assessment (n = 275)
|
-0.1 Units on a scale
Standard Deviation 0.4
|
|
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
Change at Week 4: Father Assessment (n = 216)
|
0 Units on a scale
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.
Outcome measures
| Measure |
OROS MPH
n=275 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8
Change at Week 8: Father Assessment (n = 216)
|
0 Units on a scale
Standard Deviation 0.4
|
|
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8
Change at Week 8: Mother Assessment (n = 275)
|
-0.1 Units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and 8Population: ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.
Outcome measures
| Measure |
OROS MPH
n=281 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
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|---|---|
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Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Baseline: Mother Assessment (n = 275)
|
6.4 Units on a scale
Standard Deviation 2.9
|
|
Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Baseline: Father Assessment (n = 216)
|
6.5 Units on a scale
Standard Deviation 2.5
|
|
Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Week 4: Mother Assessment (n = 280)
|
6.6 Units on a scale
Standard Deviation 2.8
|
|
Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Week 4: Father Assessment (n = 223)
|
6.7 Units on a scale
Standard Deviation 2.5
|
|
Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Week 8: Mother Assessment (n = 281)
|
6.5 Units on a scale
Standard Deviation 3
|
|
Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Week 8: Father Assessment (n = 226)
|
6.6 Units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4 and 8Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.
Outcome measures
| Measure |
OROS MPH
n=288 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Baseline: Inattention (n = 281)
|
1.5 Units on a scale
Standard Deviation 0.7
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Week 8: Inattention (n = 287)
|
1.1 Units on a scale
Standard Deviation 0.6
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Week 8: Oppositional (n = 287)
|
0.7 Units on a scale
Standard Deviation 0.7
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Baseline:Hyperactivity (n = 285)
|
1.1 Units on a scale
Standard Deviation 0.7
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Baseline: Oppositional (n = 283)
|
0.9 Units on a scale
Standard Deviation 0.7
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Week 2: Inattention (n = 286)
|
1.3 Units on a scale
Standard Deviation 0.7
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Week 2: Hyperactivity (n = 287)
|
0.9 Units on a scale
Standard Deviation 0.7
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Week 2: Oppositional (n = 286)
|
0.7 Units on a scale
Standard Deviation 0.7
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Week 4: Inattention (n = 287)
|
1.2 Units on a scale
Standard Deviation 0.6
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Week 4: Hyperactivity (n = 288)
|
0.9 Units on a scale
Standard Deviation 0.8
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Week 4: Oppositional (n = 287)
|
0.7 Units on a scale
Standard Deviation 0.7
|
|
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Week 8: Hyperactivity (n = 288)
|
0.8 Units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children's current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.
Outcome measures
| Measure |
OROS MPH
n=165 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Social Adjustment Scale Score for Children and Adolescents (SAICA)
Baseline (n = 151)
|
1.5 Units on a scale
Standard Deviation 0.7
|
|
Social Adjustment Scale Score for Children and Adolescents (SAICA)
Week 4 (n = 160)
|
1.8 Units on a scale
Standard Deviation 0.3
|
|
Social Adjustment Scale Score for Children and Adolescents (SAICA)
Week 8 (n = 165)
|
1.8 Units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4 and 8Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.
Outcome measures
| Measure |
OROS MPH
n=292 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Clinical Global Impression-Severity (CGI-S) Score
Baseline (n = 290)
|
4.3 Units on a scale
Standard Deviation 0.9
|
|
Clinical Global Impression-Severity (CGI-S) Score
Week 2 (n = 291)
|
3.5 Units on a scale
Standard Deviation 1.0
|
|
Clinical Global Impression-Severity (CGI-S) Score
Week 4 (n = 291)
|
3.1 Units on a scale
Standard Deviation 1.1
|
|
Clinical Global Impression-Severity (CGI-S) Score
Week 8 (n = 292)
|
3.0 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4 and 8Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).
Outcome measures
| Measure |
OROS MPH
n=292 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 2: Much worse (n = 292)
|
2 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 2: Very much worse (n = 292)
|
1 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 4: Very much improved (n = 262)
|
15 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 4: Much improved (n = 262)
|
111 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 4: No change (n = 262)
|
27 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 8: Minimally improved (n = 282)
|
91 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 2: Very much improved (n = 292)
|
4 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 2: Much improved (n = 292)
|
98 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 2: Minimally improved (n = 292)
|
126 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 2: No change (n = 292)
|
45 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 2: Minimally worse (n = 292)
|
16 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 4: Minimally improved (n = 262)
|
96 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 4: Minimally worse (n = 262)
|
10 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 4: Much worse (n = 262)
|
3 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 4: Very much worse (n = 262)
|
0 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 8: Very much improved (n = 282)
|
16 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 8: Much improved (n = 282)
|
129 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 8: No change (n = 282)
|
28 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 8: Minimally worse (n = 282)
|
13 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 8: Much worse (n = 282)
|
4 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Week 8: Very much worse (n = 282)
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4 and 8Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.
Outcome measures
| Measure |
OROS MPH
n=291 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Global Assessment of Satisfaction by Parents/Caregivers
Week 2 (n = 291)
|
3.4 Units on a scale
Standard Deviation 0.8
|
|
Global Assessment of Satisfaction by Parents/Caregivers
Week 4 (n = 291)
|
3.7 Units on a scale
Standard Deviation 0.8
|
|
Global Assessment of Satisfaction by Parents/Caregivers
Baseline (n = 290)
|
3.1 Units on a scale
Standard Deviation 0.9
|
|
Global Assessment of Satisfaction by Parents/Caregivers
Week 8 (n = 291)
|
3.6 Units on a scale
Standard Deviation 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 2, 4 and 8Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied.
Outcome measures
| Measure |
OROS MPH
n=291 Participants
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|
|
Global Assessment of Satisfaction by Participant
Baseline (n = 290)
|
3.2 Units on a scale
Standard Deviation 0.9
|
|
Global Assessment of Satisfaction by Participant
Week 2 (n = 291)
|
3.5 Units on a scale
Standard Deviation 0.8
|
|
Global Assessment of Satisfaction by Participant
Week 4 (n = 291)
|
3.7 Units on a scale
Standard Deviation 0.8
|
|
Global Assessment of Satisfaction by Participant
Week 8 (n = 291)
|
3.6 Units on a scale
Standard Deviation 0.9
|
Adverse Events
OROS MPH-Baseline
OROS MPH-Week 2
OROS MPH-Week 4
OROS MPH-Week 8
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OROS MPH-Baseline
n=296 participants at risk
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
OROS MPH-Week 2
n=296 participants at risk
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
OROS MPH-Week 4
n=296 participants at risk
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
OROS MPH-Week 8
n=296 participants at risk
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
|
|---|---|---|---|---|
|
General disorders
Appetite decreased
|
27.0%
80/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
33.8%
100/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
30.4%
90/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
32.1%
95/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
|
General disorders
Nausea
|
7.4%
22/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
7.4%
22/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
5.1%
15/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
5.1%
15/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
|
General disorders
Insomnia
|
7.4%
22/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
11.8%
35/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
10.1%
30/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
8.4%
25/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
|
General disorders
Headache
|
5.7%
17/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
4.7%
14/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
2.7%
8/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
2.4%
7/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
|
General disorders
Dizziness
|
4.1%
12/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
3.4%
10/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
2.0%
6/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
3.0%
9/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
|
General disorders
Somnolence
|
2.7%
8/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
1.4%
4/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
0.68%
2/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
0.34%
1/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
|
General disorders
Abdominal pain
|
5.7%
17/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
6.8%
20/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
3.7%
11/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
4.1%
12/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
|
General disorders
Stomachache
|
1.7%
5/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
1.4%
4/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
0.34%
1/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
0.34%
1/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
|
General disorders
Other
|
8.8%
26/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
10.8%
32/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
8.4%
25/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
8.1%
24/296
Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
|
Additional Information
Medical Affairs Director
Janssen Pharmaceutical, Taiwan
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60