NCT03231800

A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 95 (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 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 (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

Conditions

• Attention-Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	dasotraline	dasotraline 2mg capsule once daily
DRUG	Placebo	Placebo capsule once daily

Timeline

• Start date: 2017-07-31
• Primary completion: 2019-03-15
• Completion: 2019-03-15
• First posted: 2017-07-27
• Last updated: 2020-07-08
• Results posted: 2020-06-24

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study