drugset / Trial / NCT02402166
Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |