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

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

Official Title
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A Randomized, Multi-center, Double-blind, Cross-over Study Comparing the Efficacy and Safety of Focalin® XR 20 mg Versus Placebo at the 0.5 Hour Timepoint (Post-dose) in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dex-methylphenidate hydrochloride (Focalin XR)<br>20 mg capsule orally once a day for 7 days | Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)<br>* 20 mg capsule orally once a day for 7 days<br>* Other names: Focalin XR;|
| Placebo Comparator: Placebo<br>orally once a day for 7 days | Drug: Placebo<br>* orally once a day for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 0 hr and 0.5 hr post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 0, 1, 2, 4, 6, and 8 hr | 
| Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8) | 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. | 0, 0.5, 1, 2, 4, 6, and 8 hours | 
| Change From Pre-dose in SKAMP Deportment Score | 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. | 0, 0.5, 1, 2, 4, 6 and 8 hours | 
| 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) | Number of math questions attempted within a 10 minute period. | 0, 0.5, 1, 2, 4, 6 and 8 hours | 
| Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test | Number of math questions answered correctly within a 10 minute period. | 0, 0.5, 1, 2, 4, 6 and 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, children, laboratory classroom, Attention Deficit Hyperactivity Disorder