Evaluate the Safety and Efficacy of Methylphenidate Trans... | NCT00501293

Status Module

Description Module

Label	Type	Description	Intervention Names
1	Experimental	Methylphenidate Transdermal System	Drug: Methylphenidate Transdermal System

Name	Type	Description	Arm Group Labels	Other Names
Methylphenidate Transdermal System	Drug	One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systolic Blood Pressure		Baseline and 6 months
Diastolic Blood Pressure		Baseline and 6 months
Pulse Rate		Baseline and 6 months
Electrocardiogram Results (QTcF Interval)	QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.	Baseline and 6 months
Post Sleep Questionnaire (PSQ) Quality of Sleep	Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.	6 months
Weight		Baseline and 6 months
Dermal Reactions	Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months	The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.	Baseline and 6 months
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To be eligible for inclusion, each subject must fulfill each of the following criteria at the Entry visit:

The subject participated in the antecedent SPD485-409 study, and a) completed all required study visits (Baseline through Visit 9) OR b) completed the 5 week Dose Optimization period without achieving an acceptable condition as defined by the antecedent SPD485-409 study.
Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Entry.
Subject's ECG results are within the normal range or not clinically significant at Entry as judged by the Investigator in conjunction with the central reader.
Females must have a negative urine pregnancy test at Entry and agree to use acceptable contraceptives throughout the study period and for 30 days the last dose of IP.
Subject and parent of legally authorized representative (LAR) are able, willing and likely to fully comply with study procedures and restrictions.
Written, signed and dated informed consent to participate in the study must be given by the subject's parent or LAR, in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
There must be documentation of the subject's assent to participate in the study indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions. Failure to object is not to be considered assent.

Exclusion Criteria

Subjects will be excluded from the study if any of the following criteria are met at Entry:

Subject was discontinued from SPD485-409 due to a protocol violation, non-compliance, AE, or a serious adverse event (SAE).
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
Subject is taking any medication that is excluded.
Female subject who is pregnant or lactating.

Name	Affiliation	Role
Robert L. Findling, M.D.	University Hospitals Cleveland Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Melmed Center		Scottsdale	Arizona		United States
Bay Area Research Institute

PubMed Identifier	Type	Citation	Retractions
20973707	Result	Findling RL, Katic A, Rubin R, Moon E, Civil R, Li Y. A 6-month, open-label, extension study of the tolerability and effectiveness of the methylphenidate transdermal system in adolescents diagnosed with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):365-75. doi: 10.1089/cap.2009.0122.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
FG001	Antecedent Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG000110 BG00153 BG002163
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00014.5± 1.18 BG00114.5± 1.37 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00027 BG00114 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000110 BG00153 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months

The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Intent-to-treat (ITT) defined as subjects who were enrolled and received at least one dose of MTS and had at least one assessment of the primary efficacy endpoint.

Posted

Mean

Standard Deviation

Units on a scale

Baseline and 6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants	OG000106 OG00152

Title

Denominators

Categories

Baseline measure

Title	Measurements
	OG00016.0± 12.00 OG00127.4± 12.91

6 months

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		t-test, 2 sided	t-test of MTS at baseline and 6 months	0.028							95							Superiority or Other
OG001		t-test, 2 sided	t-test of placebo at baseline and 6 months

Secondary

Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months

The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.

ITT

Posted

Mean

Standard Deviation

Units on a scale

Baseline and 6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants

Secondary

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

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

ITT

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.

Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

ITT

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months

The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.

ITT. Not all subjects in the ITT population completed a YQOL-R.

Posted

Mean

Standard Deviation

Units on a scale

Baseline and 6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants

Primary

Systolic Blood Pressure

Safety population defined as all subjects that received at least one dose of MTS.

Posted

Mean

Standard Deviation

mmHg

Baseline and 6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants	OG000

Primary

Diastolic Blood Pressure

Safety population

Posted

Mean

Standard Deviation

mmHg

Baseline and 6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants	OG000

Primary

Pulse Rate

Safety population

Posted

Mean

Standard Deviation

beats per minute

Baseline and 6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants	OG000

Primary

Electrocardiogram Results (QTcF Interval)

QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.

Safety Population

Posted

Mean

Standard Deviation

msec

Baseline and 6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants	OG000

Primary

Post Sleep Questionnaire (PSQ) Quality of Sleep

Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.

Safety Population

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants	OG000

Primary

Weight

Safety population

Posted

Mean

Standard Deviation

Baseline and 6 months

ID	Title	Description
OG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
OG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.

Units	Counts
Participants	OG000

Primary

Dermal Reactions

Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.

Safety Population

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Antecedent MTS and Antecedent Placebo	Methylphenidate Transdermal System and Placebo Patch

Units	Counts
Participants	OG000162

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.			3	109	36	109
EG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.			1	53	32	53

Term	Organ System	Statistical Information
Seizure	Nervous system disorders	EG0002 affected109 at risk EG0010 affected53 at risk
Hallucinations	Psychiatric disorders	EG0001 affected109 at risk EG0010 affected53 at risk
Syncope	Nervous system disorders	EG0000 affected109 at risk EG0011 affected53 at risk

Term	Organ System	Statistical Information
Nasopharyngitis	Infections and infestations	EG00010 affected109 at risk EG0013 affected53 at risk
Upper respiratory tract infection	Infections and infestations	EG00011 affected109 at risk EG0016 affected53 at risk
Decreased appetite	Metabolism and nutrition disorders	EG00012 affected109 at risk EG00113 affected53 at risk
Headache	Nervous system disorders	EG00011 affected109 at risk EG0018 affected53 at risk
Irritability	Psychiatric disorders	EG0006 affected109 at risk EG0014 affected53 at risk

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Antecedent Methylphenidate Transdermal System (MTS)	Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
BG001	Antecedent Placebo	Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
BG002	Total	Total of all reporting groups