drugset / Trial / NCT00784654
Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months
Timeline
- Start
- 2009-01-27
- Primary completion
- 2011-10-26
- Completion
- 2011-10-26
Publications
- Banaschewski T, Johnson M, Lecendreux M, Zuddas A, Adeyi B, Hodgkins P, Squires LA, Coghill DR. Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs. 2014 Dec;28(12):1191-203. doi: 10.1007/s40263-014-0193-z.
- Coghill DR, Banaschewski T, Lecendreux M, Johnson M, Zuddas A, Anderson CS, Civil R, Dauphin M, Higgins N, Lyne A, Gasior M, Squires LA. Maintenance of efficacy of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder: randomized-withdrawal study design. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):647-657.e1. doi: 10.1016/j.jaac.2014.01.017. Epub 2014 Mar 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 30 mg | — |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 50 mg | — |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 70 mg | — |