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

This study has been completed.
Information provided by (Responsible Party):
Noven Therapeutics Identifier:
First received: April 25, 2007
Last updated: June 23, 2015
Last verified: June 2015
Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD

Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: Methylphenidate Transdermal System
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Noven Therapeutics:

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 [ Time Frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Clinician-rated ADHD-RS-IV score [ Time Frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours ] [ Designated as safety issue: No ]
  • CGI-I score [ Time Frame: Weeks 1-9 ] [ Designated as safety issue: No ]
  • PGA [ Time Frame: Weeks 1-9 ] [ Designated as safety issue: No ]
  • CPRS-R score [ Time Frame: Weeks 1-9 ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: August 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methylphenidate Transdermal System
Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks
Drug: Methylphenidate Transdermal System
Other Name: ADHD Patch
Placebo Comparator: Placebo
Transdermal patch, 0mg, daily for 11 weeks
Drug: Methylphenidate Transdermal System
Other Name: ADHD Patch

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

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00466791

United States, California
UCI Child Development Center
Irvine, California, United States, 92612
Sponsors and Collaborators
Noven Therapeutics
  More Information

Additional Information:
Responsible Party: Noven Therapeutics Identifier: NCT00466791     History of Changes
Other Study ID Numbers: SPD485-201 
Study First Received: April 25, 2007
Last Updated: June 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Nervous System Diseases
Neurodevelopmental Disorders
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs processed this record on May 25, 2016