Attention-Deficit Hyperactivity Disorder (ADHD) Clinical Trial
Official title:
Dasotraline (2mg) in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety in a Laboratory Classroom Setting
A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.
This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety
study in children with ADHD in a laboratory classroom setting. The study will be comprised of
3 periods: Screening (up to 35 days) including a 3 - 5 day ADHD medication washout prior to
Day -1; Double-blind randomized treatment with either dasotraline (2 mg/day) or placebo for
14 days; and a final safety evaluation 7 days after last dose. Prior to the start of
treatment (Day 1) and following the conclusion of the double-blind period (Day 15), subjects
will undergo a full-day laboratory classroom evaluation in cohorts of up to 18 subjects. Each
laboratory classroom day will include seven 30-minute simulated classroom sessions where
trained observers will assess subjects using the Swanson, Kotkin, Agler, M-Flynn, and Pelham
(SKAMP) Scale. In addition during each classroom session, a 10-minute math test (Permanent
Product Measure of Performance [PERMP]) will be administered to evaluate sustained attention
and effort. Seven (± 2) days after the last dose of study drug, subjects will return to the
clinic and complete safety assessments.
This study is designed to test the superiority of dasotraline 2 mg/day against placebo based
on Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)-Combined score in pediatric
subjects aged 6-12 years with ADHD who weigh ≤ 30 kg
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Phase 3 |