CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 92 enrolled
Drug / intervention
Methylphenidate Transdermal System (MTS) +1 moredrug
Likely dose
Methylphenidate Transdermal System (MTS) 30mgfrom 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.

Search/NCT00506285
NCT00506285Phase 3Completed
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Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD

University of Utah·interventional·Posted Jul 25, 2007·Updated Jan 16, 2015

In Brief

A Phase 3 clinical trial evaluating Methylphenidate Transdermal System (MTS) and placebo patch for Attention Deficit Hyperactivity Disorder. Completed, enrolled 92 participants across 1 site.

Detailed Summary

This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits and one baseline visit. Those who meet admission criteria will enter the double-blind phase. This will involve two 4-week treatment periods one of which will involve the use of MTS and the other a placebo patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label MTS phase designed to assess long-term effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
CollaboratorsShire

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2007
Enrollment StartJun 1, 2007
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.9 years ago

Interventions

Methylphenidate Transdermal System (MTS)drug

MTS is an advanced patch product that provides methylphenidate evenly mixed with the adhesive. This formulation allows good adhesion and a wide range of dose sizes. MTS patch sizes of 12.5, 18.75, 25 and 37.5cm2 are equivalent to nominal doses over a 9-hour wear time of 10, 15, 20 and 30mg of MPH.

placebo patchother

This patch is designed to appear identical to the actual intervention patch