Clinical trial NCT00564954: A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
children
laboratory classroom
Attention Deficit Hyperactivity Disorder
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-29
Enrollment: 86
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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
* Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate

Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: 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
timeFrame: 0 hr and 0.5 hr post-dose
Secondary outcomes:
measure: 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)
timeFrame: 0, 1, 2, 4, 6, and 8 hr
measure: Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
timeFrame: 0, 0.5, 1, 2, 4, 6, and 8 hours
measure: Change From Pre-dose in SKAMP Deportment Score
timeFrame: 0, 0.5, 1, 2, 4, 6 and 8 hours
measure: 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)
timeFrame: 0, 0.5, 1, 2, 4, 6 and 8 hours
measure: Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
timeFrame: 0, 0.5, 1, 2, 4, 6 and 8 hours
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Winter Park
country: United States
facility: Novartis Investigative Site
state: Florida
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Lubbock
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: