A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)

Summary

The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Timeline

Start

2007-06-13

Primary completion

2007-12-05

Completion

2007-12-05

Outcome

Met primary endpoint

registry analysis (unspecified test); Vyvanse vs Placebo; p <0.0001; ANCOVA; NCT00500149 ↗

paper LDX demonstrated significantly greater efficacy at each postdose time point (1.5 hours to 13.0 hours), PMID 19508731 ↗

Publications

• Results Wigal SB, Kollins SH, Childress AC, Squires L; 311 Study Group. A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. Child Adolesc Psychiatry Ment Health. 2009 Jun 9;3(1):17. doi: 10.1186/1753-2000-3-17.
• Results Wigal SB, Kollins SH, Childress AC, Adeyi B. Efficacy and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: sex and age effects and effect size across the day. Child Adolesc Psychiatry Ment Health. 2010 Dec 14;4:32. doi: 10.1186/1753-2000-4-32.

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	—

Indications