drugset / Trial / NCT00151970
Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
RandomizedCrossoverQuadruple-blindTreatment
Summary
This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
Timeline
- Start
- 2005-06
- Primary completion
- 2006-10
- Completion
- 2006-10
Publications
- Background Wilens TE, Boellner SW, Lopez FA, Turnbow JM, Wigal SB, Childress AC, Abikoff HB, Manos MJ. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):700-708. doi: 10.1097/CHI.0b013e31816bffdf.
- Frazier TW, Weiss M, Hodgkins P, Manos MJ, Landgraf JM, Gibbins C. Time course and predictors of health-related quality of life improvement and medication satisfaction in children diagnosed with attention-deficit/hyperactivity disorder treated with the methylphenidate transdermal system. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):355-64. doi: 10.1089/cap.2009.0092.
- Manos M, Frazier TW, Landgraf JM, Weiss M, Hodgkins P. HRQL and medication satisfaction in children with ADHD treated with the methylphenidate transdermal system. Curr Med Res Opin. 2009 Dec;25(12):3001-10. doi: 10.1185/03007990903388797.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylphenidate | Small molecule | 10 mg | Other |
| Comparator | Methylphenidate | Small molecule | 15 mg | Other |
| Comparator | Methylphenidate | Small molecule | 18 mg | Other |
| Comparator | Methylphenidate | Small molecule | 20 mg | Other |
| Comparator | Methylphenidate | Small molecule | 27 mg | Other |
| Comparator | Methylphenidate | Small molecule | 30 mg | Other |
| Comparator | Methylphenidate | Small molecule | 36 mg | Other |
| Comparator | Methylphenidate | Small molecule | 54 mg | Other |
| Comparator | Methylphenidate | Small molecule | 72 mg | Other |