NCT03260205

Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

A Phase 3, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-Dose Safety and Efficacy Study of SPD489 Compared With Placebo in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 4 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.
DRUG	SPD489 (Lisdexamfetamine dimesylate)	SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.
DRUG	SPD489	SPD489

Timeline

• Start date: 2017-09-06
• Primary completion: 2018-10-23
• Completion: 2018-10-23
• First posted: 2017-08-24
• Last updated: 2021-06-08
• Results posted: 2020-01-18

Locations

48 sites across 1 country: United States

Regulatory

• FDA-regulated drug study