About the 13-Hour Analog Classroom Study
This randomized, double-blind, placebo-controlled, analog study assessed the efficacy and safety of VYVANSE in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The second group received placebo the first week and their optimal dose of VYVANSE the second week.
The primary objective of this study was to assess the time of onset of VYVANSE compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) rating scale. Secondary objectives were to assess the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D, SKAMP Attention (SKAMP-A), and Permanent Product Measure of Performance (PERMP) scales.
In the study, VYVANSE demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. VYVANSE treatment was associated with significant improvement in behavior and attention as measured by both subjective (SKAMP-D) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day.
When measured using the PERMP scales, VYVANSE demonstrated significant improvement in math problems attempted and answered correctly with improvement for up to 13 hours post-dose.
Safety was also evaluated during the study and VYVANSE was gene
|SOURCE Shire plc|
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