Pharmacokinetics of Two Extended-Release Formulations of Methylphenidate in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to provide pharmacokinetic data for the assessment of bioequivalence
      of Ritalin LA formulation compared to Medikinet ret. concerning plasma levels and efficacy
      measures.

      The primary objective of the study is to determine the pharmacokinetic parameters and
      bioequivalence of Ritalin LA compared to Medikinet retard, both given as oral o.d. doses of
      20 mg over 7 days in children with ADHD. The secondary objectives are to assess the efficacy,
      safety and tolerability of Ritalin LA and Medikinet retard and the association of these
      parameters with plasma levels.
    

Detailed description: 
      Study Design

      This is a single center, Phase I, prospective, randomized, single blind, two-treatment
      cross-over study. 24 patients will be enrolled. Study duration for each patient is
      approximately 4 weeks (from screening/inclusion). Based on the assumption of 5 months
      recruitment, the total study duration will be approximately 6 month.

      Target Population

      A number of 24 prepubertal boys aged 8 - 14 years with Diagnosis of ADHD according to DSM IV
      will be enrolled in this study to ensure that 18 subjects will complete all assessments. The
      prepuberal status will be determined by Tanner stages ≤ 2. Diagnosis will be confirmed by the
      K-SADS-PL.

      Patients will only be allowed to enter the trial if subject and subject´s parents/legal
      guardians provide informed consent about participation (following full explanation of the
      trial) and a written informed consent document is signed. In addition, it has to be verified
      by a physician that the patient meets all of the Inclusion Criteria and none of the Exclusion
      Criteria.

      Study Treatment

      Study medications will be either Ritalin LA 20 mg or Medikinet ret. 20 mg. Patients with a
      pre-treatment of psychotropic drugs other than Methylphenidate will have an individual
      washout period before inclusion to the study. This individual washout period will last 5
      elimination half-life of the taken drug.

      After randomization the patients will enter a 2 week treatment phase with a crossover at day
      8. Patients randomized to Sequence 1 will be treated with Ritalin LA for the first week (day
      1 to day 7) and with Medikiniet ret. for the second week (day 8 to day 14); patients
      randomized to Sequence 2 will be treated with Medikinet ret. for the first week (day 1 to day
      7) and with Ritalin LA for the second week (day 8 to day 14). The study population will be
      randomized equally to the Sequence 1 or Sequence 2 group at Visit 2. The study ends 5 weeks
      after enrollment of the last patient (total study end).
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention description(s): Comparison of two extended-release formulations of 20mg Methylphenidate in a cross-over design.
Other intervention name(s): Ritalin LA; Medikinet retard
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Disorder; Attention Deficit an Disruptive Behavior Disorders; Children; Central Nervous System Stimulants; Methylphenidate; Pharmacokinetics; Area Under Curve; Therapeutic Equivalency; Psychopharmacology