Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      ADHD affects from 3 to 5% of children, persists into adolescence in 40 to 70% of these
      children and continues into adulthood in at least 50% of affected adolescents.
      Methylphenidate was the first medication shown to be effective in treatment for adults with
      ADHD and continues to be widely used. While the extended release formulations represent an
      improvement over the immediate release versions, significant problems remain for many
      patients. In particular, most have been designed with the goal of providing medication only
      during school hours and a short time period after school. In adults, there is a frequent need
      for much more extended duration of treatment. MTS is a new form of methylphenidate that
      provides medication in a transdermal patch delivery system. It has a very even, slowly
      ascending pharmacokinetic profile. MTS's very stable slowly increasing blood level should
      overcome the problems noted above with a delivery system that is more convenient for many
      patients. It is currently approved for treatment of childhood ADHD, with effectiveness and
      safety profiles similar to other forms of methylphenidate. This study will be the first to
      evaluate the effectiveness and safety of MTS in adult ADHD.

      This is a double-blind, placebo-controlled, randomized, crossover trial comparing MTS with
      placebo patch. The double-blind trial will be preceded by an enrollment period consisting of
      two screening visits followed as quickly as possible by a baseline visit. Patients who
      continue to meet admission criteria at baseline will be randomized into the first of two
      4-week treatment periods. We will attempt to reach the highest tolerated dose size of MTS
      within 2 weeks and then observe the response over the last two weeks of each crossover phase.
      The double-blind period will be followed by a 180 day open-treatment, flexible-dose phase
      designed to assess long-term effects.
    

Intervention name(s): Methylphenidate Transdermal System (MTS); placebo patch
Intervention type(s): Drug; Other
Intervention description(s): 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.; This patch is designed to appear identical to the actual intervention patch
Other intervention name(s): Daytrana
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; Adult; Methylphenidate Transdermal System; Daytrana