Classroom Study to Assess Efficacy and Safety of MTS in P... | NCT00466791

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

NCT00466791

Sponsor

Noven Therapeutics

Status

Completed

Last Update Posted

Jun 25, 2015Estimated

Enrollment

93Actual

Phase

Phase 2

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Methylphenidate Transdermal System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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)

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Apr 25, 2007

First Submission Date that Met QC Criteria

Apr 25, 2007

First Posted Date

Apr 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2015

Last Update Posted Date

Jun 25, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD

Detailed Description

Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methylphenidate Transdermal System	Active Comparator	Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks	Drug: Methylphenidate Transdermal System
Placebo	Placebo Comparator	Transdermal patch, 0mg, daily for 11 weeks	Drug: Methylphenidate Transdermal System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylphenidate Transdermal System	Drug	Placebo	Methylphenidate Transdermal System Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS		2,3,4.5,6,7.5,9,10.5 and 12 hours

Secondary Outcomes

Measure	Description	Time Frame
PERMP scores		pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application
Clinician-rated ADHD-RS-IV score		2,3,4.5,6,7.5,9,10.5 and 12 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCI Child Development Center		Irvine	California	92612	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16481664	Result	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. doi: 10.1177/1087054705284089.

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