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Clinical Trial Results:
From Immediate-release MPH (Methylphenidate) to OROS MPH (Osmotic Release Oral Delivery System Methylphenidate): The Impact Upon Family of Children and Adolescents With ADHD (Attention Deficit Hyperactivity Disorder)

Summary
EudraCT number	2015-001216-35
Trial protocol	Outside EU/EEA
Global end of trial date	23 Jul 2008

Results information
Results version number	v2(current)
This version publication date	01 Jul 2016
First version publication date	29 Jan 2016
Other versions	v1
Version creation reason	Correction of full data set Review of data

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CONCERTAATT4086

ISRCTN number

US NCT number

NCT00758160

WHO universal trial number (UTN)

Sponsor organisation name

Johnson & Johnson Taiwan Ltd

Sponsor organisation address

8F, 319 Tun Hwa S. Rd, Sec. 2, Taipei, Taiwan,

Public contact

Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

23 Jul 2008

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

23 Jul 2008

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to evaluate whether familial relationships and psychological status of Subjects or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms ofSubjects can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH)

Protection of trial subjects

Safety assessments included of monitoring and recording all adverse events and serious adverse events, the regular measurement of vital signs and the performance of physical examinations.

Background therapy

Evidence for comparator

Actual start date of recruitment

25 Feb 2008

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Taiwan: 296

Worldwide total number of subjects

296

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

215

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Total 296 subjects were enrolled in this study from 10 study center. Out of 296 subjects 67 subjects withdraw/terminated from the Study.

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

OROS methylphenidate

Arm description

Subjects 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.

Arm type

Experimental

Investigational medicinal product name

OROS Methylphenidate

Investigational medicinal product code

Other name

CONCERTA

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks.

Number of subjects in period 1	OROS methylphenidate
Started	296
Completed	230
Not completed	66
Consent withdrawn by subject	8
Adverse event, non-fatal	15
Administration Problems	3
No Longer Requires Study Medication	4
Lost to follow-up	14
Lack of efficacy	10
Protocol deviation	12

Baseline characteristics

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Reporting group title

Overall study

Reporting group description

Subjects received osmotic release oral delivery system (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.

Reporting group values	Overall study	Total
Number of subjects	296	296
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	215	215
Adolescents (12-17 years)	80	80
Adults (18-64 years)	1	1
From 65-84 years	0	0
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	9.5 ± 2.4	-
Gender categorical
Units: Subjects
Female	49	49
Male	247	247

End points

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Reporting group title

OROS methylphenidate

Reporting group description

Subject analysis set title

Intent-to-treat (ITT) population

Subject analysis set type

Intention-to-treat

Subject analysis set description

Intent-to-treat (ITT) analysis set included all Subjects who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement.

Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2

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End point title

Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 ^[1]

End point description

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. Here 'n' included those Subjects who were evaluable for this measure at the specified time point.

End point type

Primary

End point timeframe

Baseline and Week 2

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics were done, no inferential statistical analyses were performed

End point values	OROS methylphenidate
Number of subjects analysed	296 ^[2]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline: Inattention (n = 293)	1.7 ± 0.6
Baseline: Hyperactivity (n = 293)	1.4 ± 0.7
Baseline: Oppositional (n = 296)	1.3 ± 0.7
Change at Week 2: Inattention (n = 293)	-0.4 ± 0.5
Change at Week 2: Hyperactivity (n = 293)	-0.3 ± 0.5
Change at Week 2: Oppositional (n = 296)	-0.3 ± 0.5

Notes
[2] - ITT Population

No statistical analyses for this end point

Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4

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End point title

Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 ^[3]

End point description

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. Here 'n' included those Subjects who were evaluable for this measure at the specified time point.

End point type

Primary

End point timeframe

Baseline and Week 4

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics were done, no inferential statistical analyses were performed

End point values	OROS methylphenidate
Number of subjects analysed	296 ^[4]
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 4: Inattention (n = 293)	-0.4 ± 0.6
Change at Week 4: Hyperactivity (n = 293)	-0.3 ± 0.6
Change at Week 4: Oppositional (n = 296)	-0.3 ± 0.6

Notes
[4] - ITT Population

No statistical analyses for this end point

Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8

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End point title

Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8 ^[5]

End point description

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. Here 'n' included those Subjects who were evaluable for this measure at the specified time point.

End point type

Primary

End point timeframe

Baseline and Week 8

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics were done, no inferential statistical analyses were performed

End point values	OROS methylphenidate
Number of subjects analysed	296 ^[6]
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 8: Inattention (n = 293)	-0.5 ± 0.6
Change at Week 8: Hyperactivity (n = 293)	-0.4 ± 0.6
Change at Week 8: Oppositional (n = 296)	-0.4 ± 0.6

Notes
[6] - ITT Population

No statistical analyses for this end point

Primary: Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4

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End point title

Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4 ^[7]

End point description

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 Subjects’ 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. 'N' (number of Subjects analysed) included those Subjects who were evaluable for this measure and 'n' included those Subjects who were evaluable for this measure at specified time point.

End point type

Primary

End point timeframe

Baseline and Week 4

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics were done, no inferential statistical analyses were performed

End point values	OROS methylphenidate
Number of subjects analysed	275 ^[8]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline: Mother Assessment (n = 275)	1.9 ± 0.6
Baseline: Father Assessment (n = 216)	1.7 ± 0.4
Change at Week 4: Mother Assessment (n = 275)	-0.1 ± 0.4
Change at Week 4: Father Assessment (n = 216)	0 ± 0.3

Notes
[8] - ITT Population

No statistical analyses for this end point

Primary: Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8

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End point title

Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8 ^[9]

End point description

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 Subjects 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. 'N' (number of Subjects analyzed) included those subjects who were evaluable for this measure. Here 'n' included those Subjects who were evaluable for this measure at specified time point.

End point type

Primary

End point timeframe

Baseline and Week 8

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics were done, no inferential statistical analyses were performed

End point values	OROS methylphenidate
Number of subjects analysed	275 ^[10]
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 8: Mother Assessment (n = 275)	-0.1 ± 0.4
Change at Week 8: Father Assessment (n = 216)	0 ± 0.4

Notes
[10] - ITT Population

No statistical analyses for this end point

Secondary: Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score

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End point title

Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score

End point description

Parents of the Subjects 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. Here 'N' (number of Subjects analysed) included those Subjects who were evaluable for this measure and 'n' included those Subjects who were evaluable for this measure at specified time point.

End point type

Secondary

End point timeframe

Baseline, Week 4 and 8

End point values	OROS methylphenidate
Number of subjects analysed	281 ^[11]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline: Mother Assessment (n = 275)	6.4 ± 2.9
Baseline: Father Assessment (n = 216)	6.5 ± 2.5
Week 4: Mother Assessment (n = 280)	6.6 ± 2.8
Week 4: Father Assessment (n = 223)	6.7 ± 2.5
Week 8: Mother Assessment (n = 281)	6.5 ± 3
Week 8: Father Assessment (n = 226)	6.6 ± 2.7

Notes
[11] - ITT Population

No statistical analyses for this end point

Secondary: Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score

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End point title

Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score

End point description

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. Here 'N' (number of Subjects analysed) included those Subjects who were evaluable for this measure. 'n' included those Subjects who were evaluable for this measure at specified time point.

End point type

Secondary

End point timeframe

Baseline, Week 2, 4 and 8

End point values	OROS methylphenidate
Number of subjects analysed	288 ^[12]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline: Inattention (n = 281)	1.5 ± 0.7
Baseline:Hyperactivity (n = 285)	1.1 ± 0.7
Baseline: Oppositional (n = 283)	0.9 ± 0.7
Week 2: Inattention (n = 286)	1.3 ± 0.7
Week 2: Hyperactivity (n = 287)	0.9 ± 0.7
Week 2: Oppositional (n = 286)	0.7 ± 0.7
Week 4: Inattention (n = 287)	1.2 ± 0.6
Week 4: Hyperactivity (n = 288)	0.9 ± 0.8
Week 4: Oppositional (n = 287)	0.7 ± 0.7
Week 8: Inattention (n = 287)	1.1 ± 0.6
Week 8: Hyperactivity (n = 288)	0.8 ± 0.7
Week 8: Oppositional (n = 287)	0.7 ± 0.7

Notes
[12] - ITT Population

No statistical analyses for this end point

Secondary: Social Adjustment Scale Score for Children and Adolescents (SAICA)

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End point title

Social Adjustment Scale Score for Children and Adolescents (SAICA)

End point description

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. Here 'N' (number of Subjects analyzed) included those Subjects who were evaluable for this measure. 'n' included those Subjets who were evaluable for this measure at specified time point.

End point type

Secondary

End point timeframe

Baseline, Week 4 and Week 8

End point values	OROS methylphenidate
Number of subjects analysed	165 ^[13]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n = 151)	1.5 ± 0.7
Week 4 (n = 160)	1.8 ± 0.3
Week 8 (n = 165)	1.8 ± 0.3

Notes
[13] - ITT Population

No statistical analyses for this end point

Secondary: Clinical Global Impression-Severity (CGI-S) Score

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End point title

Clinical Global Impression-Severity (CGI-S) Score

End point description

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 Subjects’ 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. Here 'N' (number of Subjects analysed) included those Subjects who were evaluable for this measure. 'n' included those Subjects who were evaluable for this measure at specified time point.

End point type

Secondary

End point timeframe

Baseline, Week 2, 4 and 8

End point values	OROS methylphenidate
Number of subjects analysed	292 ^[14]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n = 290)	4.3 ± 0.9
Week 2 (n = 291)	3.5 ± 1
Week 4 (n = 291)	3.1 ± 1.1
Week 8 (n = 292)	3 ± 1.1

Notes
[14] - ITT Population

No statistical analyses for this end point

Secondary: Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score

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End point title

Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score

End point description

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). Here 'N' (number of Subjects analysed) included those subjects who were evaluable for this measure. 'n' included those subjects who were evaluable for this measure at specified time point.

End point type

Secondary

End point timeframe

Baseline, Week 2, 4 and 8

End point values	OROS methylphenidate
Number of subjects analysed	292 ^[15]
Units: Participants
number (not applicable)
Week 2: Very much improved (n = 292)	4
Week 2: Much improved (n = 292)	98
Week 2: Minimally improved (n = 292)	126
Week 2: No change (n = 292)	45
Week 2: Minimally worse (n = 292)	16
Week 2: Much worse (n = 292)	2
Week 2: Very much worse (n = 292)	1
Week 4: Very much improved (n = 262)	15
Week 4: Much improved (n = 262)	111
Week 4: Minimally improved (n = 262)	96
Week 4: No change (n = 262)	27
Week 4: Minimally worse (n = 262)	10
Week 4: Much worse (n = 262)	13
Week 4: Very much worse (n = 262)	0
Week 8: Very much improved (n = 282)	16
Week 8: Much improved (n = 282)	129
Week 8: Minimally improved (n = 282)	91
Week 8: No change (n = 282)	28
Week 8: Minimally worse (n = 282)	13
Week 8: Much worse (n = 282)	4
Week 8: Very much worse (n = 282)	1

Notes
[15] - ITT Population

No statistical analyses for this end point

Secondary: Global Assessment of Satisfaction by Parents/Caregivers

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End point title

Global Assessment of Satisfaction by Parents/Caregivers

End point description

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. Here 'N' (number of subjects analysed) included those Subjects who were evaluable for this measure. 'n' included those subjects who were evaluable for this measure at specified time point.

End point type

Secondary

End point timeframe

Standard Deviation

End point values	OROS methylphenidate
Number of subjects analysed	291 ^[16]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n = 290)	3.1 ± 0.9
Week 2 (n = 291)	3.4 ± 0.8
Week 4 (n = 291)	3.7 ± 0.8
Week 8 (n = 291)	3.6 ± 0.9

Notes
[16] - ITT Population

No statistical analyses for this end point

Secondary: Global Assessment of Satisfaction by Subject

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End point title

Global Assessment of Satisfaction by Subject

End point description

Subjects 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. Here 'N' (number of subjects analysed) included those subjects who were evaluable for this measure. 'n' included those subjects who were evaluable for this measure at specified time point.

End point type

Secondary

End point timeframe

Baseline, Week 2, 4 and 8

End point values	OROS methylphenidate
Number of subjects analysed	291 ^[17]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n = 290)	3.2 ± 0.9
Week 2 (n = 291)	3.5 ± 0.8
Week 4 (n = 291)	3.7 ± 0.8
Week 8 (n = 291)	3.6 ± 0.9

Notes
[17] - ITT Po

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline upto End of treatment

Adverse event reporting additional description

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.

Assessment type

Non-systematic

Dictionary name

No dictionary use

Dictionary version

Reporting group title

OROS MPH-Baseline

Reporting group description

Subjects 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 subject based on clinical responses and/or side effects.

Reporting group title

OROS MPH-Week 4

Reporting group description

Reporting group title

OROS MPH-Week 8

Reporting group description

Reporting group title

OROS MPH-Week 2

Reporting group description

Serious adverse events	OROS MPH-Baseline	OROS MPH-Week 4	OROS MPH-Week 8	OROS MPH-Week 2
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 296 (0.00%)	0 / 296 (0.00%)	0 / 296 (0.00%)	0 / 296 (0.00%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	OROS MPH-Baseline	OROS MPH-Week 4	OROS MPH-Week 8	OROS MPH-Week 2
Total subjects affected by non serious adverse events
subjects affected / exposed	80 / 296 (27.03%)	90 / 296 (30.41%)	95 / 296 (32.09%)	100 / 296 (33.78%)
General disorders and administration site conditions
Appetite decreased
subjects affected / exposed	80 / 296 (27.03%)	90 / 296 (30.41%)	95 / 296 (32.09%)	100 / 296 (33.78%)
occurrences all number	81	91	95	101
Nausea
subjects affected / exposed	22 / 296 (7.43%)	15 / 296 (5.07%)	15 / 296 (5.07%)	22 / 296 (7.43%)
occurrences all number	22	15	15	22
Insomnia
subjects affected / exposed	22 / 296 (7.43%)	30 / 296 (10.14%)	25 / 296 (8.45%)	35 / 296 (11.82%)
occurrences all number	23	30	25	35
Headache
subjects affected / exposed	17 / 296 (5.74%)	8 / 296 (2.70%)	7 / 296 (2.36%)	14 / 296 (4.73%)
occurrences all number	17	8	7	14
Dizziness
subjects affected / exposed	17 / 296 (5.74%)	8 / 296 (2.70%)	7 / 296 (2.36%)	14 / 296 (4.73%)
occurrences all number	12	6	9	10
Somnolence
subjects affected / exposed	8 / 296 (2.70%)	2 / 296 (0.68%)	1 / 296 (0.34%)	4 / 296 (1.35%)
occurrences all number	8	2	1	4
Abdominal pain
subjects affected / exposed	17 / 296 (5.74%)	11 / 296 (3.72%)	12 / 296 (4.05%)	20 / 296 (6.76%)
occurrences all number	17	11	12	20
Stomachache
subjects affected / exposed	5 / 296 (1.69%)	1 / 296 (0.34%)	1 / 296 (0.34%)	4 / 296 (1.35%)
occurrences all number	5	1	1	4

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: From Immediate-release MPH (Methylphenidate) to OROS MPH (Osmotic Release Oral Delivery System Methylphenidate): The Impact Upon Family of Children and Adolescents With ADHD (Attention Deficit Hyperactivity Disorder)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2

Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2

Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4

Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4

Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8

Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8

Primary: Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4

Primary: Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4

Primary: Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8

Primary: Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8

Secondary: Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score

Secondary: Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score

Secondary: Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score

Secondary: Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score

Secondary: Social Adjustment Scale Score for Children and Adolescents (SAICA)

Secondary: Social Adjustment Scale Score for Children and Adolescents (SAICA)

Secondary: Clinical Global Impression-Severity (CGI-S) Score

Secondary: Clinical Global Impression-Severity (CGI-S) Score

Secondary: Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score

Secondary: Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score

Secondary: Global Assessment of Satisfaction by Parents/Caregivers

Secondary: Global Assessment of Satisfaction by Parents/Caregivers

Secondary: Global Assessment of Satisfaction by Subject

Secondary: Global Assessment of Satisfaction by Subject

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
From Immediate-release MPH (Methylphenidate) to OROS MPH (Osmotic Release Oral Delivery System Methylphenidate): The Impact Upon Family of Children and Adolescents With ADHD (Attention Deficit Hyperactivity Disorder)