Characterization of Dermal Reactions in Pediatric Patients With Attention Deficit/Hyperactivity Disorder (ADHD) Using DAYTRANA

This study has been completed.

Sponsor:

Information provided by:

Shire Development LLC

ClinicalTrials.gov Identifier:

NCT00434213

First received: February 12, 2007

Last updated: January 3, 2011

Last verified: January 2011

History of Changes

Results First Received: February 4, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Attention Deficit Hyperactivity Disorder
Intervention:	Drug: Daytrana

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Daytrana	Methylphenidate Transdermal System (MTS)

Participant Flow: Overall Study

	Daytrana
STARTED	309
COMPLETED	260
NOT COMPLETED	49
Adverse Event	12
Lack of Efficacy	9
Lost to Follow-up	14
Withdrawal by Subject	7
Protocol Violation	3
Unable to comply with study visit window	2
Application site reaction	1
Non-compliant to study schedule	1

Baseline Characteristics

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Reporting Groups

	Description
Daytrana	Methylphenidate Transdermal System (MTS)

Baseline Measures

	Daytrana
Number of Participants [units: participants]	309
Age [units: participants]
<=18 years	309
Between 18 and 65 years	0
>=65 years	0
Age [units: years] Mean ± Standard Deviation	9.1 ± 1.95
Gender [units: participants]
Female	91
Male	218
Region of Enrollment [units: participants]
United States	309

Outcome Measures

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1. Primary:

Dermal Reactions [ Time Frame: 7 weeks ]

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2. Secondary:

Contact Sensitization to Methylphenidate [ Time Frame: 7 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after SPONSOR confirms there shall be no multicenter Study publication, the INSTITUTION and/or such PRINCIPAL INVESTIGATOR may publish the results from the INSTITUTION site individually.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Timothy Whitaker, M.D.
Organization: Shire Pharmaceutical Development Inc.
e-mail: twhitaker@shire.com

Publications of Results:

Warshaw EM, Squires L, Li Y, et al. Methylphenidate Transdermal System: A Multisite, Open-Label Study of Dermal Reactions in Pediatric Patients Diagnosed With ADHD. Primary Care Companion Journal Clinical Psychiatry; 12(6): e1-e9, 2010 (published online).

Responsible Party:	Timothy Whitaker, M.D., Clinical Research and Development - VP of Global Clinical Medicine, Shire Pharmaceutical Development Inc.
ClinicalTrials.gov Identifier:	NCT00434213 History of Changes
Other Study ID Numbers:	SPD485-411
Study First Received:	February 12, 2007
Results First Received:	February 4, 2009
Last Updated:	January 3, 2011
Health Authority:	United States: Food and Drug Administration

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