Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00151996 ↗

Phase 2 Completed 75 enrolled Shire

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17

Timeline

Start: 2004-08-16
Primary completion: 2004-12-27
Completion: 2004-12-27

Outcome

Met primary endpoint

registry analysis (unspecified test); Methylphenidate + SPD503; p <0.0001; t-test, 2 sided NCT00151996 ↗

registry analysis (unspecified test); Amphetamine + SPD503; p <0.0001; t-test, 2 sided NCT00151996 ↗

Publications

Results Spencer TJ, Greenbaum M, Ginsberg LD, Murphy WR. Safety and effectiveness of coadministration of guanfacine extended release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):501-10. doi: 10.1089/cap.2008.0152.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Guanfacine	Small molecule	1 mg	—
Subject	Guanfacine	Small molecule	2 mg	—
Subject	Guanfacine	Small molecule	3 mg	—
Subject	Guanfacine	Small molecule	4 mg	—
Background	Amphetamine	Unknown	—	—
Background	Methylphenidate	Small molecule	—	—