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

Noven Therapeutics93 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Methylphenidate Transdermal SystemDRUG

Placebo

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

UCI Child Development Center

Irvine, California, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Clinician-rated ADHD-RS-IV score

Time frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours

CGI-I score

Time frame: Weeks 1-9

PGA

Time frame: Weeks 1-9

CPRS-R score

Time frame: Weeks 1-9

Data from ClinicalTrials.gov

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