A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)

Phase 4

Completed

Conditions: Attention Deficit Hyperactivity Disorder

Interventions: Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)
Drug: Placebo

Registration Number: NCT00564954

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

Inclusion Criteria

Male and female subjects aged 6-12 years, inclusive.
Subjects meeting the DSM-IV criteria for ADHD of any type, 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 (Concerta® 36 mg and 54 mg is allowable)

Exclusion Criteria

Parent or guardian unable or unwilling to complete the Conner's ADHD/DSM-IV Scale for Parents (CADS-P) and the Daily Diary Card
Diagnosed with 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, AST, GGPT or serum creatinine greater then 2X the ULN 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) are excluded
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dex-methylphenidate hydrochloride (Focalin XR)	Dex-methylphenidate hydrochloride extended-release (Focalin XR)	20 mg capsule orally once a day for 7 days
Placebo	Placebo	orally once a day for 7 days

Primary Outcome Measures

Name	Time	Method
Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day	0 hr and 0.5 hr post-dose	SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.

Secondary Outcome Measures

Name	Time	Method
Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test-Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)	0, 0.5, 1, 2, 4, 6 and 8 hours	Number of math questions attempted within a 10 minute period.
Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)	0, 1, 2, 4, 6, and 8 hr	SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.
Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)	0, 0.5, 1, 2, 4, 6, and 8 hours	SKAMP attention sub-scale is comprised of 7 questions evaluating concentration in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42.
Change From Pre-dose in SKAMP Deportment Score	0, 0.5, 1, 2, 4, 6 and 8 hours	SKAMP deportment sub-scale is comprised of 6 questions on behavior in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36.
Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test	0, 0.5, 1, 2, 4, 6 and 8 hours	Number of math questions answered correctly within a 10 minute period.