Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years

Summary

The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.

Timeline

Start

2017-12-09

Primary completion

2018-06-07

Completion

2018-06-07

Outcome

Missed primary endpoint

paper At week 4, the least squares mean (95% confidence interval) treatment differences (SHP465 MAS-placebo) were not statistically significant for ADHD-RS-5-HV-TS PMID 33185468 ↗

registry analysis (superiority test); Placebo vs SHP465; p = 0.451; Difference in LS Mean -1.9 (95% CI -6.8 to 3.1) NCT03325881 ↗

Publications

• Mattingly G, Arnold V, Yan B, Yu M, Robertson B. A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2020 Nov;30(9):549-557. doi: 10.1089/cap.2020.0005. Epub 2020 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SHP465	Unknown	6.25 mg	Oral

Indications