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dc.contributor.authorBivard, A
dc.contributor.authorLillicrap, T
dc.contributor.authorKrishnamurthy, V
dc.contributor.authorHolliday, E
dc.contributor.authorAttia, J
dc.contributor.authorPagram, H
dc.contributor.authorNilsson, M
dc.contributor.authorParsons, M
dc.contributor.authorLevi, CR
dc.date.accessioned2020-12-17T03:29:57Z
dc.date.available2020-12-17T03:29:57Z
dc.date.issued2017-05-01
dc.identifierpii: STROKEAHA.116.016293
dc.identifier.citationBivard, A., Lillicrap, T., Krishnamurthy, V., Holliday, E., Attia, J., Pagram, H., Nilsson, M., Parsons, M. & Levi, C. R. (2017). MIDAS (Modafinil in Debilitating Fatigue After Stroke) A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial. STROKE, 48 (5), pp.1293-1298. https://doi.org/10.1161/STROKEAHA.116.016293.
dc.identifier.issn0039-2499
dc.identifier.urihttp://hdl.handle.net/11343/254912
dc.description.abstractBACKGROUND AND PURPOSE: This study aimed to assess the efficacy of modafinil, a wakefulness-promoting agent in alleviating post-stroke fatigue ≥3 months after stroke. We hypothesized that 200 mg of modafinil daily for 6 weeks would result in reduced symptoms of fatigue compared with placebo. METHODS: This single-center phase 2 trial used a randomized, double-blind, placebo-controlled, crossover design. The key inclusion criterion was a multidimensional fatigue inventory score of ≥60. Patients were randomized to either modafinil or placebo for 6 weeks of therapy, then after a 1 week washout period swapped treatment arms for a second 6 weeks of therapy. The primary outcome was the multidimensional fatigue inventory; secondary outcomes included the Montreal cognitive assessment, the Depression, Anxiety, and Stress Scale (DASS), and the Stroke-Specific Quality of Life (SSQoL) scale. The multidimensional fatigue inventory is a self-administered questionnaire with a range of 0 to 100. Treatment efficacy was assessed using linear regression by estimating within-person, baseline-adjusted differences in mean outcomes after therapy. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000350527). RESULTS: A total of 232 stroke survivors were screened and 36 were randomized. Participants receiving modafinil reported a significant decrease in fatigue (multidimensional fatigue inventory, -7.38; 95% CI, -21.76 to -2.99; P<0.001) and improved quality of life (SSQoL, 11.81; 95% CI, 2.31 to 21.31; P=0.0148) compared with placebo. Montreal cognitive assessment and DASS were not significantly improved with modafinil therapy during the study period (P>0.05). CONCLUSIONS: Stroke survivors with nonresolving fatigue reported reduced fatigue and improved quality of life after taking 200 mg daily treatment with modafinil. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527.
dc.languageEnglish
dc.publisherLIPPINCOTT WILLIAMS & WILKINS
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0
dc.titleMIDAS (Modafinil in Debilitating Fatigue After Stroke) A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial
dc.typeJournal Article
dc.identifier.doi10.1161/STROKEAHA.116.016293
melbourne.affiliation.departmentMedicine (RMH)
melbourne.affiliation.facultyMedicine, Dentistry & Health Sciences
melbourne.source.titleStroke
melbourne.source.volume48
melbourne.source.issue5
melbourne.source.pages1293-1298
dc.rights.licenseCC BY-NC
melbourne.elementsid1225784
melbourne.contributor.authorParsons, Mark
melbourne.contributor.authorBivard, Andrew
dc.identifier.eissn1524-4628
melbourne.accessrightsOpen Access


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