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Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial.

Vasconcelos OM, Prokhorenko OA, Salajegheh MK, Kelley KF, Livornese K, Olsen CH, Vo AH, Dalakas MC, Halstead LS, Jabbari B, Campbell WW

Department of Neurology, Uniformed Services University of the Health Sciences, Bethesda, MD, USA. ovasconcelos@usuhs.mil

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.

Published 15 May 2007 in Neurology, 68(20): 1680-6.
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