drugset / Trial / NCT02402166

Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder

NCT02402166

Phase 2 Completed 24 enrolled Shire
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD population.

Timeline

Start
2015-04-15
Primary completion
2016-06-30
Completion
2016-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Lisdexamfetamine Dimesylate Small molecule 5 mg
Subject Lisdexamfetamine Dimesylate Small molecule 10 mg
Subject Lisdexamfetamine Dimesylate Small molecule 15 mg
Subject Lisdexamfetamine Dimesylate Small molecule 20 mg
Subject Lisdexamfetamine Dimesylate Small molecule 30 mg