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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics
ClinicalTrials.gov Identifier:
NCT00466791
First received: April 25, 2007
Last updated: June 23, 2015
Last verified: June 2015

April 25, 2007
June 23, 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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00466791
SPD485-201
No
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