Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial
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, receivin...
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| Language: | English |
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Wiley
2011-01-01
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| Series: | Neurology Research International |
| Online Access: | http://dx.doi.org/10.1155/2011/514351 |
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| author | 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 |
| author_facet | 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 |
| author_sort | D. V. Tembe |
| collection | DOAJ |
| description | 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<.0001). Responder rates with armodafinil (72.12%) and modafinil (74.29%) were comparable (𝑃=.76). Adverse event incidences were comparable. Conclusion. Armodafinil was found to be safe and effective in the treatment of SWSD in Indian patients. The study did not demonstrate any difference in efficacy and safety of armodafinil 150 mg and modafinil 200 mg. |
| format | Article |
| id | doaj-art-d79fba56598941778fae0ddc1a959e56 |
| institution | Kabale University |
| issn | 2090-1852 2090-1860 |
| language | English |
| publishDate | 2011-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Neurology Research International |
| spelling | doaj-art-d79fba56598941778fae0ddc1a959e562025-02-03T05:45:22ZengWileyNeurology Research International2090-18522090-18602011-01-01201110.1155/2011/514351514351Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical TrialD. V. Tembe0A. Dhavale1H. Desai2D. N. Mane3S. K. Raut4G. Dhingra5U. Sardesai6S. Saoji7M. Rohra8V. G. Shinde9M. Padsalge10A. Paliwal11K. Abbasi12P. Devnani13S. Papinwar14S. Phadke15H. Mehta16V. Bhailume17Manovedh Clinic, Karad 415110, IndiaA.J. Medical Care Pvt. Ltd., Mulshi, Pune 411027, IndiaDr. Hemang Desai's Clinic, Ahmedabad 380007, IndiaNoble Hospital, Pune 411013, IndiaDhanvantari Hospital, Pune 411028, IndiaDr. Gurpreet Dhingra's Clinic, Santacruz (W), Mumbai 400049, IndiaSamvedana, Indore 452003, IndiaSaoji-Tupkari Hospital, Aurangabad 431005, IndiaDr. Manoj Rohra's Clinic, Santacruz (W), Mumbai 400049, IndiaShinde's Medicare Hospital Pvt. Ltd., Andheri, Mumbai 400053, IndiaShivam Clinic and Research Centre, Nerul, Navi Mumbai 400706, IndiaDr. Abhay Paliwal's Clinic, Indore 452001, IndiaJeswani Hospital, Nagpur 440002, IndiaSleep Disorder Clinic, Khar, Mumbai 40052, IndiaPapinwar Hospital, Aurangabad, 431001, IndiaDr. Sanjay Phadke's Clinic, Kothrud, Pune 411038, IndiaDr. Hemal Mehta's Clinic, Vile Parle (E), Mumbai 400057, IndiaDr. Vilas Bhailume's Clinic, Karve Nagar, Pune 411052, IndiaAim. 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<.0001). Responder rates with armodafinil (72.12%) and modafinil (74.29%) were comparable (𝑃=.76). Adverse event incidences were comparable. Conclusion. Armodafinil was found to be safe and effective in the treatment of SWSD in Indian patients. The study did not demonstrate any difference in efficacy and safety of armodafinil 150 mg and modafinil 200 mg.http://dx.doi.org/10.1155/2011/514351 |
| spellingShingle | 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 Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial Neurology Research International |
| title | Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial |
| title_full | Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial |
| title_fullStr | Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial |
| title_full_unstemmed | Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial |
| title_short | Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial |
| title_sort | armodafinil versus modafinil in patients of excessive sleepiness associated with shift work sleep disorder a randomized double blind multicentric clinical trial |
| url | http://dx.doi.org/10.1155/2011/514351 |
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