Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)

Summary

The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.

Timeline

Start

2015-11-19

Primary completion

2016-03-24

Completion

2016-03-24

Outcome

Met primary endpoint

paper Least-squares mean (95% confidence interval) treatment differences at week 4 significantly favored SHP465 MAS over placebo for the ADHD-RS-AP total score change from baseline PMID 28712074 ↗

registry Placebo vs SHP465 12.5 mg; p <0.001; Difference of LS Mean -8.1 (95% CI -11.7 to -4.4) NCT02604407 ↗

registry Placebo vs SHP465 37.5 mg; p <0.001; Difference of LS Mean -13.4 (95% CI -17.1 to -9.7) NCT02604407 ↗

release “The primary efficacy analysis of study 306 showed that SHP465 12.5mg and 37.5mg, both administered as a daily morning dose, were superior to placebo” takeda.com ↗

Publications

• Weisler RH, Greenbaum M, Arnold V, Yu M, Yan B, Jaffee M, Robertson B. Efficacy and Safety of SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled, Forced-Dose Clinical Study. CNS Drugs. 2017 Aug;31(8):685-697. doi: 10.1007/s40263-017-0455-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SHP465	Unknown	12.5 mg	—
Subject	SHP465	Unknown	37.5 mg	—

Indications