Safety and Efficacy of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

Summary

The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom setting based on the Permanent Product Measure of Performance (PERMP) total score assessed across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind crossover period.

Timeline

Start

2011-03-06

Primary completion

2011-05-04

Completion

2011-05-04

Outcome

Outcome not reported

Stopped: “Cancellation was not safety related but a shift in study priorities for Shire.”

Drugs

Indications