Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD

This study has been completed.

Sponsor:

Information provided by:

Shire Development LLC

ClinicalTrials.gov Identifier:

NCT00466791

First received: April 25, 2007

Last updated: July 23, 2009

Last verified: November 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	April 25, 2007
Last Updated Date	July 23, 2009
Start Date ^ICMJE	August 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: April 25, 2007)	Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00466791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 25, 2007)	PERMP scores Clinician-rated ADHD-RS-IV score CGI-I score PGA CPRS-R score
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
Official Title ^ICMJE	A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary	Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Attention Deficit Disorder With Hyperactivity
Intervention ^ICMJE	Drug: d,l (threo)-methylphenidate, Methylphenidate Transdermal System
Study Arm (s)	Not Provided
Publications *	McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006 Feb;9(3):476-85.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	93
Completion Date	May 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Primary diagnosis ADHD Total score of greater than or equal to 26 on ADHD-RS-IV IQ of greater than or equal to 80 Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline Exclusion Criteria: Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) Known nonresponder to psychostimulant treatment BMI for age greater than 90th percentile History of seizures during last 2 years Conduct Disorder
Gender	Both
Ages	6 Years to 12 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00466791
Other Study ID Numbers ^ICMJE	SPD485-201
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Shire Development LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Shire Development LLC
Verification Date	November 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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