Tags

Type your tag names separated by a space and hit enter

A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design.
Postgrad Med 2018; 130(5):481-493PM

Abstract

OBJECTIVES

The objective of this paper was to evaluate the efficacy, duration of effect, and tolerability of SHP465 mixed amphetamine salts (MAS) extended-release versus placebo and immediate-release MAS (MAS IR) in adults with attention-deficit/hyperactivity disorder (ADHD).

METHODS

Adults with ADHD Rating Scale, Version IV (ADHD-RS-IV) scores ≥24 were randomized to SHP465 MAS (50 or 75 mg), placebo, or 25 mg MAS IR in a double-blind, three-period, crossover study using a simulated adult workplace environment. On the final day of each 7-day treatment period, efficacy was assessed for 16 h postdose. Primary efficacy analyses for Permanent Product Measure of Performance (PERMP) total score averaged across all postdose assessments and each postdose time point were conducted in the intent-to-treat population using a mixed linear model. Secondary end-points included PERMP problems attempted and answered correctly and ADHD-RS-IV scores based on clinician ratings of counselor observations using the Time Segment Rating System and participant self-report. Tolerability assessments included treatment-emergent adverse events (TEAEs) and vital signs.

RESULTS

Least squares mean (95% CI) treatment differences (combined 50/75 mg SHP465 MAS-placebo) significantly favored SHP465 MAS over placebo for PERMP total score averaged across all postdose assessments (18.38 [11.28, 25.47]; P < .0001) and at each postdose assessment (all P < .02). Nominal superiority of MAS IR over placebo for PERMP total score averaged across all postdose assessments was observed (nominal P = .0001); treatment differences between SHP465 MAS and MAS IR were not significant (nominal P = .2443). The two most frequently reported TEAEs associated with SHP465 MAS were insomnia (36.5%) and anorexia (21.2%). Mean increases in pulse and blood pressure with SHP465 MAS exceeded those of placebo.

CONCLUSIONS

SHP465 MAS (combined 50/75 mg) significantly improved PERMP total score versus placebo, with superiority observed from 2 to 16 h postdose. The tolerability profile of SHP465 MAS was similar to previous reports of SHP465 MAS in adults with ADHD.

CLINICAL TRIAL REGISTRATION

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

Authors+Show Affiliations

a AVIDA Inc ., Newport Beach , CA , USA.b Department of Psychiatry & Behavioral Sciences , Baylor College of Medicine , Houston , TX , USA.c Formerly of Global Clinical Development , Shire , Lexington , MA , USA.d Biostatistics , Shire , Lexington , MA , USA.e Global Medical Affairs , Shire , Lexington , MA , USA.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29809075

Citation

Wigal, Timothy, et al. "A Randomized, Double-blind Study of SHP465 Mixed Amphetamine Salts Extended-release in Adults With ADHD Using a Simulated Adult Workplace Design." Postgraduate Medicine, vol. 130, no. 5, 2018, pp. 481-493.
Wigal T, Brams M, Frick G, et al. A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design. Postgrad Med. 2018;130(5):481-493.
Wigal, T., Brams, M., Frick, G., Yan, B., & Madhoo, M. (2018). A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design. Postgraduate Medicine, 130(5), pp. 481-493. doi:10.1080/00325481.2018.1481712.
Wigal T, et al. A Randomized, Double-blind Study of SHP465 Mixed Amphetamine Salts Extended-release in Adults With ADHD Using a Simulated Adult Workplace Design. Postgrad Med. 2018;130(5):481-493. PubMed PMID: 29809075.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design. AU - Wigal,Timothy, AU - Brams,Matthew, AU - Frick,Glen, AU - Yan,Brian, AU - Madhoo,Manisha, Y1 - 2018/06/18/ PY - 2018/5/29/pubmed PY - 2018/8/9/medline PY - 2018/5/30/entrez KW - ADHD rating scale time segment rating system KW - ADHD self-rating scale KW - Adult workplace environment KW - SHP465 mixed amphetamine salts KW - attention-deficit/hyperactivity disorder KW - duration of effect KW - permanent product measure of performance SP - 481 EP - 493 JF - Postgraduate medicine JO - Postgrad Med VL - 130 IS - 5 N2 - OBJECTIVES: The objective of this paper was to evaluate the efficacy, duration of effect, and tolerability of SHP465 mixed amphetamine salts (MAS) extended-release versus placebo and immediate-release MAS (MAS IR) in adults with attention-deficit/hyperactivity disorder (ADHD). METHODS: Adults with ADHD Rating Scale, Version IV (ADHD-RS-IV) scores ≥24 were randomized to SHP465 MAS (50 or 75 mg), placebo, or 25 mg MAS IR in a double-blind, three-period, crossover study using a simulated adult workplace environment. On the final day of each 7-day treatment period, efficacy was assessed for 16 h postdose. Primary efficacy analyses for Permanent Product Measure of Performance (PERMP) total score averaged across all postdose assessments and each postdose time point were conducted in the intent-to-treat population using a mixed linear model. Secondary end-points included PERMP problems attempted and answered correctly and ADHD-RS-IV scores based on clinician ratings of counselor observations using the Time Segment Rating System and participant self-report. Tolerability assessments included treatment-emergent adverse events (TEAEs) and vital signs. RESULTS: Least squares mean (95% CI) treatment differences (combined 50/75 mg SHP465 MAS-placebo) significantly favored SHP465 MAS over placebo for PERMP total score averaged across all postdose assessments (18.38 [11.28, 25.47]; P < .0001) and at each postdose assessment (all P < .02). Nominal superiority of MAS IR over placebo for PERMP total score averaged across all postdose assessments was observed (nominal P = .0001); treatment differences between SHP465 MAS and MAS IR were not significant (nominal P = .2443). The two most frequently reported TEAEs associated with SHP465 MAS were insomnia (36.5%) and anorexia (21.2%). Mean increases in pulse and blood pressure with SHP465 MAS exceeded those of placebo. CONCLUSIONS: SHP465 MAS (combined 50/75 mg) significantly improved PERMP total score versus placebo, with superiority observed from 2 to 16 h postdose. The tolerability profile of SHP465 MAS was similar to previous reports of SHP465 MAS in adults with ADHD. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT00928148 identifier is NCT00928148. SN - 1941-9260 UR - https://www.unboundmedicine.com/medline/citation/29809075/A_randomized_double_blind_study_of_SHP465_mixed_amphetamine_salts_extended_release_in_adults_with_ADHD_using_a_simulated_adult_workplace_design_ L2 - http://www.tandfonline.com/doi/full/10.1080/00325481.2018.1481712 DB - PRIME DP - Unbound Medicine ER -