Efficacy and Safety of Dex-Methylphenidate Extended Release 20 mg Versus Placebo in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Dex-methylphenidate extended release (Drug); Placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

This study will confirm the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.

Official title: A Randomized, Multi-Center, Double-Blind, Cross-Over Study Comparing the Efficacy and Safety of Dex-Methylphenidate Extended Release 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Change in The Swanson, Kotkin, Agler, M Flynn and Pelham (SKAMP) Combined score from pre-dose (0 Hour) to 0.5, 1, 2, 4, 6 and 8 hours post-dose. The primary analysis time point is 0.5 hour post-dose.

Secondary outcome:

Change from pre-dose in SKAMP Attention score (at all hours post-dose)

Change from pre-dose in SKAMP Deportment score (at all hours post-dose)

Change from pre-dose in Math Test-attempt scores (at all hours post-dose)

Change from pre-dose in Math Test-correct scores (at all hours post-dose)

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Novartis Investigative Site, Little Rock, Arkansas 72205, United States

Novartis Investigative Site, Winter Park, Florida 32792, United States

Novartis Investigative Site, Las Vegas, Nevada 89128, United States

Novartis Investigative Site, Houston, Texas 77007, United States

Novartis Investigative Site, Lubbock, Texas 79423, United States

Starting date: October 2007
Ending date: November 2007
Last updated: December 18, 2007