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

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

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00466791

Enrollment

Registered

2007-04-27

Start date

2004-08-31

Completion date

2005-05-31

Last updated

2015-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

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

Interventions

DRUGMethylphenidate Transdermal System

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

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

Design outcomes

Primary

Measure	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

Measure	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
CGI-I score	Weeks 1-9
PGA	Weeks 1-9
CPRS-R score	Weeks 1-9

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026