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Abstract
Objective: To determine if modafinil can improve fatigue in patients with post-polio syndrome.
Methods: We used a randomized, placebo-controlled crossover trial. Intervention with modafinil (400 mg/day) and placebo occurred over 6-week periods. Primary endpoint (fatigue) was assessed using the Fatigue Severity Scale as the main outcome measure. Other measures included the Visual Analog Scale for Fatigue and the Fatigue Impact Scale. Secondary endpoint (health-related quality of life) was assessed using the 36-Item Short-Form. Analysis of variance for repeated measures was applied to assess treatment, period, and carryover effects.
Results: Thirty-six patients were randomized, 33 of whom (mean age: 61 years) completed required interventions. Treatment with modafinil was safe and well-tolerated. After adjusting for periods and order effects, no difference was observed between treatments.
Conclusion: Based on the utilized measures of outcome modafinil was not superior to placebo in alleviating fatigue or improving quality of life in the studied post-polio syndrome population.
Footnotes
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Sponsored by the Post-Polio Syndrome Program through a grant from the Department of Defense to the Uniformed Services University of the Health Sciences (Health Affairs, Grant MDA 905-01-007). The PPS Program is administered under the auspices of the Henry Jackson Foundation (HJF, www.hjf.org), Rockville, Maryland. The funding organization had no role in the study design, data collection, data analyses, interpretation of results, or drafting of the final report. The corresponding author had full access to the data and has final responsibility for the information submitted for publication.
Disclaimer: The opinions or assertions contained herein are the private views of the authors and are not to be construed as official, or as reflecting the views of the Department of the Army or the Department of Defense.
Disclosure: The authors report no conflicts of interest.
Presented in part at the annual meeting of the American Academy of Neurology; San Diego, CA; Neurology 2006; P04.201(suppl 2):A248.
Received August 17, 2006. Accepted in final form January 10, 2007.
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