Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR); Placebo
Intervention description: 10 mg and/or 20 mg capsules; Placebo Comparator
Intervention MeSH terms: Methylphenidate; Dexmethylphenidate Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD, children, subjects, laboratory classroom

Summary:

      This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30
      mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity
      Disorder (ADHD) in a 12-hour laboratory classroom setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 6-12 years, inclusive.

          -  Subjects meeting the DSM-IV criteria for primary diagnosis of ADHD-Combined type, or
             predominantly hyperactive-impulsive subtype, as established by the K-SADS-PL (Kiddie
             Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a
             DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity,
             the subject will not be enrolled into the study.

          -  Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg
             methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to
             Screening visit.

        Exclusion Criteria:

          -  Subject or subject's guardian unable to understand or follow instructions necessary to
             participate in the study.

          -  Diagnosed with or history of a tic disorder or Tourette's syndrome.

          -  History of seizure disorder.

          -  The presence of a known medical condition that would preclude the use of
             methylphenidate.

          -  A history (within the past year) or presence of clinically significant cardiovascular,
             cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological,
             hematological, endocrine, or neurological disease.

          -  ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), GGT (Gamma
             glutamyl transferase) or serum creatinine greater then 2X the ULN (Upper Limit of
             Normal) at Screening.

          -  A history of psychiatric illness or substance use disorder (e.g., schizophrenia,
             bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or
             severe Oppositional defiant disorder)

          -  Subjects who have participated in an investigational trial within the past 4 weeks (28
             days)

          -  Subjects who are currently taking antidepressants or other psychotropic medication.

          -  Subjects who have initiated psychotherapy during the three months prior to
             randomization.

          -  Subjects with a positive urine drug screen.

          -  Subjects who have a history of poor response or intolerance to methylphenidate or
             d-methylphenidate.

        Other protocol-defined inclusion/exclusion criteria may apply