Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial

Autor: D. V. Tembe, A. Dhavale, H. Desai, D. N. Mane, S. K. Raut, G. Dhingra, U. Sardesai, S. Saoji, M. Rohra, V. G. Shinde, M. Padsalge, A. Paliwal, K. Abbasi, P. Devnani, S. Papinwar, S. Phadke, H. Mehta, V. Bhailume
Jazyk: angličtina
Rok vydání: 2011
Předmět:
Zdroj: Neurology Research International, Vol 2011 (2011)
Druh dokumentu: article
ISSN: 2090-1852
2090-1860
DOI: 10.1155/2011/514351
Popis: Aim. To compare the efficacy and safety of armodafinil, the R-enantiomer of modafinil, with modafinil in patients of shift work sleep disorder (SWSD). Material and Methods. This was a 12-week, randomized, comparative, double-blind, multicentric, parallel-group study in 211 patients of SWSD, receiving armodafinil (150 mg) or modafinil (200 mg) one hour prior to the night shift. Outcome Measures. Efficacy was assessed by change in stanford sleepiness score (SSS) by at least 2 grades (responder) and global assessment for efficacy. Safety was assessed by incidence of adverse events, change in laboratory parameters, ECG, and global assessment of tolerability. Results. Both modafinil and armodafinil significantly improved sleepiness mean grades as compared to baseline (𝑃
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