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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466791
First Posted: April 27, 2007
Last Update Posted: June 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Noven Therapeutics
April 25, 2007
April 27, 2007
June 25, 2015
August 2004
May 2005   (Final data collection date for primary outcome measure)
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 ]
Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS
Complete list of historical versions of study NCT00466791 on ClinicalTrials.gov Archive Site
  • 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 ]
  • PERMP scores
  • Clinician-rated ADHD-RS-IV score
  • CGI-I score
  • PGA
  • CPRS-R score
Not Provided
Not Provided
 
Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
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)
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
Drug: Methylphenidate Transdermal System
Placebo
Other Name: ADHD Patch
  • Active Comparator: Methylphenidate Transdermal System
    Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks
    Intervention: Drug: Methylphenidate Transdermal System
  • Placebo Comparator: Placebo
    Transdermal patch, 0mg, daily for 11 weeks
    Intervention: Drug: Methylphenidate Transdermal System
McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006 Feb;9(3):476-85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
May 2005
May 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00466791
SPD485-201
No
Not Provided
Not Provided
Noven Therapeutics
Noven Therapeutics
Not Provided
Not Provided
Noven Therapeutics
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP