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.

Study Overview
=================
Brief 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.

Official Title
-----------------
A Randomized, Multi-center, Double-blind, Placebo-controlled, Cross-over Study Evaluating the Safety and Efficacy of Dex-Methylphenidate Extended Release 30 mg vs. 20 mg as Measured by SKAMP-Combined Scores in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder (ADHD)

Intervention / Treatment
-----------------
* Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)
* Drug: Placebo


Participation Criteria
=================
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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg<br>Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days. | Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)<br>* 10 mg and/or 20 mg capsules<br>|
| Active Comparator: Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg<br>Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days. | Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)<br>* 10 mg and/or 20 mg capsules<br>|
| Placebo Comparator: Placebo<br>Two Capsules taken orally once a day for 7 days | Drug: Placebo<br>* Placebo Comparator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose | SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement. | Pre-dose to 10, 11, and 12 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose | SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement. | Pre-dose to 10, 11, and 12 hours post-dose | 
| Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose | SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement. | Pre-dose to 10, 11, and 12 hours post-dose | 
| Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose | Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to academic productivity. A positive score indicates improvement. | Pre-dose to 10, 11, and 12 hours post-dose | 
| Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose | Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to academic productivity. A positive score indicates improvement. | Pre-dose to 10, 11, and 12 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, children, subjects, laboratory classroom