ADHD
Conditions
Keywords
ADHD, children
Brief summary
The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.
Interventions
DRUGFocalin XR
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* DSM-IV diagnosis of ADHD * Males and females aged 6-12
Exclusion criteria
* Inability to understand or follow instructions * Is pregnant * Diagnosis of tic disorder * History of seizure disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in attention and deportment measured at 2 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose | — |
| Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline | — |
| Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD. | — |
Countries
United States
Outcome results
None listed