Clinical Trial: Modafinil to Treat Fatigue in Post-Polio Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Modafinil in the Treatment of Fatigue in Post-Polio Syndrome

Brief Summary:

This study, conducted at the Walter Reed Army Medical Center, the National Rehabilitation Hospital, and the National Institutes of Health, will examine whether the drug Modafinil can decrease fatigue in patients with post-polio syndrome. Many people who have had polio develop weakness and severe fatigue several years after their recovery from the acute disease. Modafinil is approved by the Food and Drug Administration to improve wakefulness in patients with narcolepsy (disease in which patients have excessive daytime sleepiness) and has been used to treat patients with fatigue related to other medical conditions, such as multiple sclerosis. This study will compare the effects of two doses of Modafinil and of a placebo (a pill with no active ingredient) on fatigue in patients with post-polio syndrome.

Patients who develop fatigue, weakness, muscle pain or atrophy, and functional loss at least 15 years after recovering from polio and whose symptoms cannot be attributed to another cause may be eligible for this study. Candidates will be screened with a medical history, physical and neurological examinations, fatigue rating scales, electrocardiogram, blood and urine tests, drowsiness and depression evaluations, and an electroymogram (EMG) to diagnose nerve or muscle problems. For the EMG, electrodes (small metal discs) are taped to the skin and a needle is inserted into a muscle to record the electrical activity.

Candidates will also undergo a sleep study to exclude abnormal sleep patterns as the cause of the fatigue. For this study, patients stay overnight at the NIH hospital. Electrodes are placed on the throat, on a finger, and on the chest (for an electrocardiogram), and a respiratory belt is placed around the chest-abdomen area. During sleep (from 10:30 p.m. to 6 a.m.), brain waves, eye and leg movements, muscle tone, res

Detailed Summary: The main objective of this study is to determine if the drug Modafinil is effective in the treatment of fatigue in patients with post-polio syndrome (PPS). PPS is a motor neuron disease experience by more than 400,000 Americans, characterized by new weakness and intense fatigue. The cause of fatigue, the most common and disabiling symptom in these patients, is unknown and there is no effective treatment. In the present study, selected PPS patients will be randomized to receive two different doses of Modafinil or placebo. After six weeks, the patients will enter a two-week wash out period, and then will be crossed over to the other arm. The sample size has been powered to reflect a significant difference in the scales of fatigue. Secondary exploratory studies will include investigation of sleep patterns as a cause contributing to fatigue and a search for upregulation of fatigue-associated cytokines in the patient's serum and CSF.
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Current Primary Outcome: Ascertain whether modafinil is of any benefit in alleviating the fatigue of Post-Polio Syndrome.

Original Primary Outcome:

Current Secondary Outcome: Determine if fatigue reduction, correlates with improvement in quality of life of subjects with Post-Polio Syndrome. Investigate the pathophysiology of Post-Polio Syndrome by the study of serum and CSF for evidence of inflammatory markers.

Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: August 20, 2003
Date Started: August 2003
Date Completion: August 2006
Last Updated: August 26, 2008
Last Verified: May 2005