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

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ClinicalTrials.gov Identifier: NCT00466791
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : June 25, 2015
Information provided by (Responsible Party):
Noven Therapeutics

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

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Methylphenidate Transdermal System Phase 2

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : August 2004
Primary Completion Date : May 2005
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. Clinician-rated ADHD-RS-IV score [ Time Frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours ]
  3. CGI-I score [ Time Frame: Weeks 1-9 ]
  4. PGA [ Time Frame: Weeks 1-9 ]
  5. CPRS-R score [ Time Frame: Weeks 1-9 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466791

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

Additional Information:
Responsible Party: Noven Therapeutics
ClinicalTrials.gov Identifier: NCT00466791     History of Changes
Other Study ID Numbers: SPD485-201
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

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