Long-term Safety and Effectiveness of OROS Methylphenidate HCl in Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety and effectiveness of OROSÂ®
      Methylphenidate HCl (a central nervous system stimulant) in children with attention deficit
      hyperactivity disorder (ADHD).
    

Detailed description: 
      Attention Deficit Hyperactivity Disorder (ADHD) represents the most common neurobehavioral
      disorder in children, affecting 3% to 5% of the school-age population. Behavioral
      pediatricians, child psychiatrists, and child neurologists indicate that referrals for ADHD
      may constitute up to 50% of their practices. This is a multicenter, open-label,
      non-randomized, single-treatment study in children 6 to 13 years of age with ADHD who have
      successfully completed specific earlier ALZA studies. Part I of this study will evaluate the
      safety and effectiveness of OROS® (methylphenidate HCl) for a period of one year in children
      with ADHD. Part II of this study continues the evaluation of the safety and effectiveness of
      OROS® (methylphenidate HCl) in children with ADHD who have completed one year in Part I of
      the study. During Part I of the study, patients will be assigned to treatment with OROS®
      (methylphenidate HCl) 18, 36, or 54 milligrams once daily, as determined by the results from
      their participation in earlier ALZA studies. Patients continuing in Part II of the study
      continue to receive a daily dose as determined from the dosing at the end of Part I. Doses
      can be titrated up or down, as considered appropriate by the medical personnel at the study
      site, with a maximum once-daily dose of 54 milligrams. Effectiveness is determined by
      standardized measurements of attention, behavior, and hyperactivity including: the IOWA
      (Inattention Overactivity with Aggression) Conners Rating Scale, Inattention/Overactivity
      (I/O) and Oppositional/Defiance (O/D) subscales; Peer Interaction assessment; Global
      evaluation of effectiveness of therapy; and the Parent Satisfaction Questionnaire. Safety
      evaluations include the incidence of adverse events, physical examinations, clinical
      laboratory tests, vital signs, sleep quality, appetite, and the presence/severity of tics
      (hard-to-control, repeated twitching of any parts of the body or hard-to-control repeating of
      sounds or words).

      Data will be summarized and no formal hypotheses will be tested. Part I: A daily morning oral
      dose of 18, 36, or 54 milligrams of OROS® (methylphenidate HCl) for up to 12 months. Part II:
      Continuation for up to 15 months of the same daily dose taken at the end of Part I. Total
      treatment duration to approximately 27 months.
    

Intervention name(s): methylphenidate HCl
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactivity Disorder; OROS®; children; methylphenidate