Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

Summary

The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.

Timeline

Start

2015-06-18

Primary completion

2016-02-16

Completion

2016-02-16

Outcome

Met primary endpoint

paper significantly favored SHP465 MAS over placebo for ADHD-RS-IV total score change from baseline to week 4 (-9.9 [-13.0, -6.8]; p < 0.001 PMID 28816509 ↗

release “The primary efficacy analysis of study 305 demonstrated that SHP465, administered as a daily morning dose, was superior to placebo” takeda.com ↗

Publications

• Results Brams M, Childress AC, Greenbaum M, Yu M, Yan B, Jaffee M, Robertson B. SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Results of a Randomized, Double-Blind Placebo-Controlled Study. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):19-28. doi: 10.1089/cap.2017.0053. Epub 2017 Aug 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SHP465	Unknown	12.5 mg	—
Subject	SHP465	Unknown	25 mg	—

Indications