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)
1 other identifier
interventional
93
1 country
1
Brief Summary
Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2004
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 25, 2007
CompletedFirst Posted
Study publicly available on registry
April 27, 2007
CompletedJune 25, 2015
June 1, 2015
9 months
April 25, 2007
June 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS
2,3,4.5,6,7.5,9,10.5 and 12 hours
Secondary Outcomes (5)
PERMP scores
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
2,3,4.5,6,7.5,9,10.5 and 12 hours
CGI-I score
Weeks 1-9
PGA
Weeks 1-9
CPRS-R score
Weeks 1-9
Study Arms (2)
Methylphenidate Transdermal System
ACTIVE COMPARATORTransdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks
Placebo
PLACEBO COMPARATORTransdermal patch, 0mg, daily for 11 weeks
Interventions
Placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCI Child Development Center
Irvine, California, 92612, United States
Related Publications (1)
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. doi: 10.1177/1087054705284089.
PMID: 16481664RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2007
First Posted
April 27, 2007
Study Start
August 1, 2004
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
June 25, 2015
Record last verified: 2015-06