NCT01274221

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

A Phase 3b, Randomized, Double-blind, Multicenter, Placebo Controlled, Dose Optimization, Crossover, Analog Classroom, Safety and Efficacy Study of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD))

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	SPD489	1 capsule per day throughout the open-label treatment phase and for one week of the double-blind crossover phase
OTHER	Placebo	1 capsule per day for one week of the double-blind crossover phase

Timeline

• Start date: 2011-03-06
• Primary completion: 2011-05-04
• Completion: 2011-05-04
• First posted: 2011-01-11
• Last updated: 2021-06-03

Locations

6 sites across 1 country: United States