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

Phase 3 Completed 113 enrolled Shire

Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2015-08-21
Primary completion: 2020-01-03
Completion: 2020-01-03

Publications

Childress AC, Lloyd E, Johnson SA Jr, Gunawardhana L, Arnold V. A Long-Term, Open-Label Safety and Tolerability Study of Lisdexamfetamine Dimesylate in Children Aged 4-5 Years with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2022 Mar;32(2):98-106. doi: 10.1089/cap.2021.0138. Epub 2022 Mar 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lisdexamfetamine Dimesylate	Small molecule	5 mg	Oral
Subject	Lisdexamfetamine Dimesylate	Small molecule	10 mg	Oral
Subject	Lisdexamfetamine Dimesylate	Small molecule	15 mg	Oral
Subject	Lisdexamfetamine Dimesylate	Small molecule	20 mg	Oral
Subject	Lisdexamfetamine Dimesylate	Small molecule	30 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications