Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Methylphenidate Transdermal System; Drug: Placebo; Drug: Concerta

• Registration Number: NCT00444574
• Lead Sponsor: Noven Therapeutics

Brief Summary

Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.

Detailed Description

This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2007-03-06
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• male or female aged 6-12 years
• females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.
• a primary diagnosis of ADHD based on a detailed psychiatric evaluation
• a total score of =>26 on the ADHD-RS-IV at the Baseline Visit
• a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above
• no comorbid illness that could affect safety or tolerability or in any way interfere with the subject's participation in the study.

EXCLUSION CRITERIA:

• a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
• a known non-responder to psychostimulant treatment
• overweight (Body Mass Index (BMI)-for-age >90th percentile)
• a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
• Conduct Disorder.
• Subject has taken an investigational drug within 30 days prior to Screening.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylphenidate Transdermal System	Methylphenidate Transdermal System	Methylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks
Placebo	Placebo	Placebp matching MTS and Concerta for 7 weeks
Concerta	Concerta	Methylphenidate HCL 18mg tablet 7 weeks

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit.	7 weeks

Secondary Outcome Measures

Name	Time	Method
CTRS-R, CPRS-R, CGI, PGA scores	7 weeks
Treatment emergent AEs, dermal evaluations, PK	7 weeks