NCT02466386

Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder

A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed With Attention-deficit / Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 4 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).

Detailed description

This study is a long-term, open-label study where participants who participated in an antecedent SPD489 study (SPD489-211 \[NCT02402166\] or SPD489-347 \[NCT03260205\]) or through direct enrollment. Participants entering into this study will be classified as either a roll-over participants or a direct-enrolled participants.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	SPD489	Participants will receive 5 mg of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached.

Timeline

• Start date: 2015-08-21
• Primary completion: 2020-01-03
• Completion: 2020-01-03
• First posted: 2015-06-09
• Last updated: 2021-03-05
• Results posted: 2021-03-05

Locations

50 sites across 1 country: United States

Regulatory

• FDA-regulated drug study