NCT02734693

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.

A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of Dasotraline in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.

Detailed description

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 (4 mg/day) or placebo for14 days; and End of Study (EOS) Visit (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 during which approximately 12 to 18 subjects will be assessed. 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.

Conditions

• Attention-Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	dasotraline 4mg	dasotraline 4mg/day
OTHER	Placebo	placebo/day

Timeline

• Start date: 2016-04-30
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2016-04-12
• Last updated: 2020-03-27
• Results posted: 2020-03-27

Locations

5 sites across 1 country: United States