At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 128 enrolled
Drug / intervention
Methylphenidate Transdermal System +2 moredrug
Likely dose
Methylphenidate Transdermal System 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
In Brief
A Phase 2 clinical trial evaluating Methylphenidate Transdermal System, Placebo, and 1 other intervention for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 128 participants.
Detailed Summary
This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsNoven Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedSep 2005
Primary CompletionOct 2006
TodayJul 2026
First PostedSep 9, 2005
Enrollment StartJun 1, 2005
Primary CompletionOct 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.8 years ago
Interventions
Methylphenidate Transdermal Systemdrug
MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes
Placebodrug
Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily
Concertadrug
CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily