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

Novartis Pharmaceuticals1 site in 1 country86 target enrollmentOctober 2007

ConditionsAttention Deficit Hyperactivity Disorder

InterventionsDex-methylphenidate hydrochloride extended-release (Focalin XR)Placebo

DrugsDex-methylphenidate hydrochloride extended-release (Focalin XR)Placebo

Overview

Phase: Phase 4
Intervention: Dex-methylphenidate hydrochloride extended-release (Focalin XR)
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Novartis Pharmaceuticals
Enrollment: 86
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

November 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Dex-methylphenidate hydrochloride (Focalin XR)

20 mg capsule orally once a day for 7 days

Intervention: Dex-methylphenidate hydrochloride extended-release (Focalin XR)

Placebo

orally once a day for 7 days

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

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)
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)
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)
Change From Pre-dose in SKAMP Deportment Score(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(0, 0.5, 1, 2, 4, 6 and 8 hours)