HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Figures Only Full Text Full Text (PDF) Correspondence: Submit a response Correspondence: View responses Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Vasconcelos, O. M. Articles by Campbell, W. W. Search for Related Content PubMed PubMed Citation Articles by Vasconcelos, O. M. Articles by Campbell, W. W. Related Collections Viral infections Anterior nerve cell disease All Clinical trials Clinical trials Randomized controlled (CONSORT agreement)

Modafinil for treatment of fatigue in post-polio syndrome

A randomized controlled trial

From the Department of Neurology (O.M.V., O.A.P., K.F.K., K.L., C.H.O., A.H.V., B.J., W.W.C.), Uniformed Services University of the Health Sciences (USUHS), Bethesda; Neuromuscular Diseases Section (M.K.S., M.C.D.), National Institutes of Health, Bethesda, MD; and Neuroscience Department (L.S.H.), National Rehabilitation Hospital, Washington, DC.

Address correspondence and reprint requests to Dr. Olavo M. Vasconcelos, 4301 Jones Bridge Rd., Bldg. 53/Room 101, Bethesda, MD 20814 ovasconcelos{at}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.

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.

This article has been cited by other articles:

				R. A. Rison, O. M. Vasconcelos, K. Kenney, and W. W. Campbell MODAFINIL FOR TREATMENT OF FATIGUE IN POST-POLIO SYNDROME: A RANDOMIZED CONTROLLED TRIAL Neurology, February 26, 2008; 70(9): 736 - 738. [Full Text] [PDF]

Correspondence: