Journal article
Modafinil In Debilitating fatigue After Stroke (MIDAS): Study protocol for a randomised, double-blinded, placebo-controlled, crossover trial
T Lillicrap, V Krishnamurthy, J Attia, M Nilsson, CR Levi, MW Parsons, A Bivard
Trials | BIOMED CENTRAL LTD | Published : 2016
Open access
Abstract
Background: Fatigue is a common symptom in stroke survivors for which there is currently no proven therapy. Modafinil is a wakefulness-promoting agent with established benefits in other disease models. We aim to test if modafinil will improve patient's self-reported fatigue scores when compared to placebo and if therapy results in increased quality of life. Methods/design: MIDAS is a phase II, single-centre, prospective, double-blinded, randomised, crossover trial of modafinil for the treatment of persistent fatigue in survivors of ischaemic stroke. The inclusion criteria will require an average score of 12 or more across all domains of the Multi-dimensional Fatigue Inventory (MFI-20) and th..
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Funding Acknowledgements
This study is funded externally by the Australian National Stroke Foundation. All study researchers have access to the use of the trial data and are permitted to perform secondary analysis for publication. There are no restrictions imposed on the research team by any external bodies. All study researchers and clinicians who referred participants enrolled in the trial will be granted authorship status for the final trial publication. The trial results will be disseminated by publication in a peer-reviewed journal.