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NCT00067496 · ClinicalTrials.gov registry record · Phase 3
Modafinil to Treat Fatigue in Post-Polio Syndrome
A Phase 3 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Terminated
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT00067496 is a Phase 3 study that was terminated before completion, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants.
The verdict
NCT00067496, a Phase 3 study, was terminated before completion, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study 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, respiration, and heart rate are recorded. Beginning at 8 a.m. the following morning, the patient takes 20-minute naps to measure the level of dayti
Interventions
- DRUG Modafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2003-08 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00067496
The ClinicalTrials.gov registry entry for NCT00067496 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Modafinil is the first listed.
NCT00067496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00067496 about?
NCT00067496 is a clinical study titled "Modafinil to Treat Fatigue in Post-Polio Syndrome". 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 fat...
What is the current status of trial NCT00067496?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2003-08. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00067496?
The interventions under investigation include: Modafinil (DRUG).
Who is sponsoring clinical trial NCT00067496?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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