Primary endpoint: Significant improvement from predose SKAMP-combined score at 4 hours postdose vs placebo (P<0.0001)

LS, least squares

Secondary endpoints: Significant improvement from predose SKAMP-combined scores at each timepoint measured postdose (1, 2, 6, 8, 10, 12 & 13 hrs) vs placebo (P<0.0001 for each)

LS, least squares

Study Details: This dose-optimized, randomized, double-blind, placebo-controlled laboratory classroom study included 99 children aged 6 to 12 years who met DSM-IV-TR criteria for ADHD. In the 5 week open-label dose-optimization period, patients received a starting dose of 2.5 or 5mg of DYANAVEL XR taken once daily in the morning. The dose was titrated by 2.5mg to 10mg increments every 4 to 7 days until an optimal dose or the maximum daily dose of 20mg/day was reached. Patients who achieved an optimal dose during the dose optimization period entered the double blind portion of the study where they were randomized to either DYANAVEL XR at their optimal dose or placebo once daily for one week. E cacy was assessed on the final day of the double-blind phase, by teachers and raters using the SKAMP rating scale. The primary endpoint was the change from predose in the model-adjusted average of SKAMP-combined score at 4 hours postdose. Secondary endpoints looked at change from predose SKAMP-combined scores at 1, 2, 6, 8, 10, 12 and 13 hours postdose.

LS, least squares

The SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) rating scale, often used in clinical trials, is a validated rating instrument, used by trained raters to specifically measure the observed classroom manifestations of ADHD. The items of the SKAMP are specific for place (the classroom) and time (a typical class period). The scale’s items describe typical behaviors in a classroom setting, and additional items that describe behaviors associated with ADHD in the classroom. The SKAMP method of assessment has been demonstrated to be a sensitive measure of attention and behavior within a lab classroom setting.

LS, least squares