Principal Investigator: Lauro S. Halstead, MD, MPH

Funding Source: Uniformed Services University of the Health Sciences (USUHS)

Background: Post-Polio Syndrome (PPS) is a medical condition in which there is the occurrence of new weakness, severe fatigue, or other symptoms related to an earlier illness with acute polio. Fatigue is the most common and disabling problem and currently there exists no effective treatment for fatigue in persons with PPS. This study tests if a medication called modafinil (Provigil) can help reduce the fatigue of patients with PPS. This drug has been approved by the Food and Drug Administration (FDA) to improve wakefulness in patients with excessive sleepiness associated with a sleeping disorder called narcolepsy. It has not been approved for treatment in PPS, but it has been used to treat patients with fatigue related to other conditions, like multiple sclerosis or obstructive sleep apnea. Other studies have shown that modafinil increases wakefulness and alertness without serious side effects and is not habit-forming. Modafinil is considered a safe drug and side effects are usually not a major problem for individuals taking it for narcolepsy and other sleep disorders.

Specific Aims: 1) Determine the effects of modafinil on PPS; 2) Investigate presence of cytokines, imflammatory markers, in the blood of persons with PPS

Study Design: Approximately 100 individuals with PPS and complaining of fatigue will take part in the study, 30 to be recruited through NRH. This is a double blind study to compare two different doses of modafinil and placebo to investigate what effects they might have on fatigue. The study uses a crossover design; each subject takes both modafinil and placebo, but in a different sequence. Blood and spinal fluid (optional) will be drawn from subjects and analyzed for the presence of cytokines at the National Institutes of Health (NIH). Subjects' diagnoses of PPS will be confirmed by EMG (electromyelogram) and they will complete three different rating forms for fatigue: the Fatigue Impact Scale; the Visual Analog Scale for Fatigue; and the Fatigue Severity Scale. Depression and the presence of a sleep disorder as a cause of fatigue will be ruled out.

After completion of screening procedures, subjects with be randomized to one of two groups. One group receives modafinil first, then the placebo. The order of administration is reversed for the second group. Each group takes medications in two, four-week blocks varying the doses as instructed. Blood is drawn and forms are readministered at the end of each block. A "washout" period is planned between the two medication blocks.