Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

Phase 3 Completed 338 enrolled Shire

RandomizedParallel-groupTriple-blindTreatment

Summary

For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

Timeline

Start: 2011-01-17
Primary completion: 2013-05-01
Completion: 2013-05-01

Outcome

Met primary endpoint

registry analysis (unspecified test); Placebo vs Guanfacine Hydrochloride; p <0.001; Difference in Least Squares Mean -8.9 (95% CI -11.9 to -5.8); ANCOVA NCT01244490 ↗

Publications

Results Hervas A, Huss M, Johnson M, McNicholas F, van Stralen J, Sreckovic S, Lyne A, Bloomfield R, Sikirica V, Robertson B. Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial. Eur Neuropsychopharmacol. 2014 Dec;24(12):1861-72. doi: 10.1016/j.euroneuro.2014.09.014. Epub 2014 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atomoxetine	Other / unclassified	10 mg	—
Subject	Atomoxetine	Other / unclassified	100 mg	—
Subject	Guanfacine	Small molecule	0.05 mg/kg	—
Subject	Guanfacine	Small molecule	0.12 mg/kg	—
Subject	Guanfacine	Small molecule	1 mg	—
Subject	Guanfacine	Small molecule	4 mg	—
Subject	Guanfacine	Small molecule	7 mg	—