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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Methylphenidate Transdermal System

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCI Child Development Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylphenidate Transdermal System

Placebo

Arm Description

Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks

Transdermal patch, 0mg, daily for 11 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PERMP scores

Clinician-rated ADHD-RS-IV score

CGI-I score

PGA

CPRS-R score

Full Information

NCT ID

NCT00466791

First Posted

April 25, 2007

Last Updated

June 23, 2015

Sponsor

Noven Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00466791

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Noven Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Disorder With Hyperactivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methylphenidate Transdermal System

Arm Type

Active Comparator

Arm Description

Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Transdermal patch, 0mg, daily for 11 weeks

Intervention Type

Drug

Intervention Name(s)

Methylphenidate Transdermal System

Other Intervention Name(s)

ADHD Patch

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

2,3,4.5,6,7.5,9,10.5 and 12 hours

Secondary Outcome Measure Information:

Title

PERMP scores

Time Frame

pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application

Title

Clinician-rated ADHD-RS-IV score

Time Frame

2,3,4.5,6,7.5,9,10.5 and 12 hours

Title

CGI-I score

Time Frame

Weeks 1-9

Title

PGA

Time Frame

Weeks 1-9

Title

CPRS-R score

Time Frame

Weeks 1-9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

UCI Child Development Center

City

Irvine

State/Province

California

ZIP/Postal Code

92612

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16481664

Citation

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.

Results Reference

result

Links:

URL

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?CFID=20377655&CFTOKEN=caaa9085d296aa43-A8C6AE4E-1143-D1C5-FB7BD1C853149DF7

Description

FDA-approved labelling information, US only

URL

http://www.fda.gov/opacom/7alerts.html

Description

FDA Recall information

Learn more about this trial

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

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