A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design

Abstract

https://clinicaltrials.gov/ct2/show/NCT00928148 identifier is NCT00928148.

A randomized, double-blind, 3-way crossover, analog classroom study of SHP465 mixed amphetamine salts extended-release in adolescents with ADHD

“…The reason for the later onset of efficacy in adults treated with 25 mg SHP465 MAS is unknown at this time. The superiority of 12.5 mg MAS IR over placebo observed in this study is also consistent with previous findings from an AWE study of SHP465 MAS, in which 25 mg MAS IR was nominally superior to placebo from 2 to 16 hours postdose [17]. Furthermore, in a laboratory classroom study of children diagnosed with ADHD, 10 mg MAS IR improved performance significantly more than placebo on the SKAMP (1.5-7.5 hours postdose for attention; 1.5-10.5 hours postdose for deportment) and on the PERMP (1.5-9.0 hours postdose for number attempted and number correct) [5].…”

“…The observed effects of SHP465 MAS on secondary efficacy endpoints generally complemented the primary endpoint, with nominal superiority of SHP465 MAS over placebo observed for PERMP problems attempted and answered correctly and for ADHD-SRS, SKAMP, CPRS-R, and ADHD-RS-IV scores. The findings for SHP465 MAS from this study are partially consistent with those of similarly designed studies in adults that used the AWE model [16,17], with 25 mg SHP465 MAS and 50/75 mg SHP465 MAS producing significantly greater PERMP total score improvements than placebo when averaged over a 16-hour postdose period. Although onset of efficacy was observed at 2 hours postdose with 50/75 mg SHP465 MAS in adults with ADHD [17], the onset of efficacy was observed at 4 hours postdose with 25 mg SHP465 MAS in adults with ADHD [16].…”

“…The findings for SHP465 MAS from this study are partially consistent with those of similarly designed studies in adults that used the AWE model [16,17], with 25 mg SHP465 MAS and 50/75 mg SHP465 MAS producing significantly greater PERMP total score improvements than placebo when averaged over a 16-hour postdose period. Although onset of efficacy was observed at 2 hours postdose with 50/75 mg SHP465 MAS in adults with ADHD [17], the onset of efficacy was observed at 4 hours postdose with 25 mg SHP465 MAS in adults with ADHD [16]. The reason for the later onset of efficacy in adults treated with 25 mg SHP465 MAS is unknown at this time.…”

“…In both studies, which utilized the Adult Workplace Environment (AWE) model [18], SHP465 MAS produced significantly greater improvement than placebo in PERMP total score averaged across all postdose time assessments from 2 to 16 hours. Significantly greater PERMP total scores versus placebo were observed for 25 mg SHP465 MAS from 4 to 16 hours postdose [16] and for 50/ 75 mg SHP465 MAS from 2 to 16 hours postdose [16,17]. The most frequently reported treatment-emergent adverse events (TEAEs) with SHP465 MAS in these studies were insomnia, anorexia, decreased appetite, dry mouth, and headache [16,17].…”

“…Two different SHP465 MAS studies [16,17], which used crossover designs similar to this study, were conducted in adults with ADHD [16,17]. In both studies, which utilized the Adult Workplace Environment (AWE) model [18], SHP465 MAS produced significantly greater improvement than placebo in PERMP total score averaged across all postdose time assessments from 2 to 16 hours.…”