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Artigos Científicos

segunda-feira, 17 outubro 2016 13:54

The Time Course of Effect of Multilayer-Release Methylphenidate Hydrochloride Capsules: A Randomized, Double-Blind Study of Adults With ADHD in a Simulated Adult Workplace Environment

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Sharon B. Wigal1, Tim Wigal1, Ann Childress2, Graeme A. E. Donnelly3, Joseph L. Reiz3

1
AVIDA, Newport Beach, CA, USA
2
Center for Psychiatry and Behavioral Medicine Inc., Las Vegas, NV, USA
3
Purdue Pharma Canada, Pickering, Ontario, Canada

Journal of Attention Disorders: SAGE Journals

October 17, 2016


ABSTRACT:

Objective: The aim of this study is to assess the onset and duration of efficacy of multilayer-release methylphenidate (PRC-063) over 16 hr compared with placebo in adults with ADHD using the simulated adult workplace environment.

Method: After dose-optimization with PRC-063, participants entered a double-blind, placebo-controlled, crossover phase. Primary outcome measure was the Permanent Product Measure of Performance (PERMP) total score measured pre-dose and from 1 to 16 hr post-dose.

Results: Of the 59 randomized participants, 45 participants completed the study. While receiving PRC-063, adults had greater mean PERMP total scores across all time points compared with placebo (268.7 ± 11.24 vs. 255.6 ± 10.87; p = .0064). Common adverse events were decreased appetite, headache, and insomnia. There was no significant impact on overall sleep quality (p = .9542).

Conclusion: PRC-063 significantly improved PERMP scores with an onset within 1 hr post-dose, and maintained improvement throughout the 16 hr post-dose study period compared with placebo in adults with ADHD.


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