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

This study has been completed.
Information provided by:
Shire Identifier:
First received: March 6, 2007
Last updated: May 6, 2009
Last verified: February 2008

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).

Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • 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. [ Time Frame: 7 weeks ]

Secondary Outcome Measures:
  • CTRS-R, CPRS-R, CGI, PGA scores [ Time Frame: 7 weeks ]
  • Treatment emergent AEs, dermal evaluations, PK [ Time Frame: 7 weeks ]

Enrollment: 282
Study Start Date: September 2004
Study Completion Date: June 2005

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.


  • 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.
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Additional Information:
No publications provided by Shire

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00444574     History of Changes
Other Study ID Numbers: SPD485-302
Study First Received: March 6, 2007
Last Updated: May 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Attention Deficit Hyperactivity Disorder (ADHD)

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors processed this record on September 22, 2014