Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067496
Status:
TERMINATED
Last Update Posted:
2008-08-27
First Post:
2003-08-20
Brief Title:
Modafinil to Treat Fatigue in Post-Polio Syndrome
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Modafinil in the Treatment of Fatigue in Post-Polio Syndrome
Status:
TERMINATED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1030 pm to 6 am brain waves eye and leg movements muscle tone respiration and heart rate are recorded Beginning at 8 am the following morning the patient takes 20-minute naps to measure the level of daytime sleepiness using a recording technique similar to that of the all-night study When five naps are completed the sleep study ends Candidates may also undergo a lumbar puncture spinal tap to check for certain chemicals in the spinal fluid that might be related to fatigue and to look for possible causes of post-polio syndrome This procedure is optional For the lumbar puncture a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord A small amount of fluid is collected through the needle
Patients enrolled in the study will complete a sleep diary during the entire study period They will be randomly assigned to one of two treatment groups-Modafinil or placebo-for 6 weeks followed by a 2-week washout period with no medication and then a crossover phase in which patients who took Modafinil for the first 6 weeks now take placebo and those who took placebo now take Modafinil
At the first study visit patients will be given a supply of study medication and have blood drawn They will take one pill twice a day during both study phases In both study phases evaluations will be done 3 and 6 weeks after starting the medication The evaluations include filling out the same forms completed at the screening visit a review of drug side effects and a review of medical problems since the last study visit At the 6-week visit blood is also drawn
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 1030 pm to 6 am brain waves eye and leg movements muscle tone respiration and heart rate are recorded Beginning at 8 am the following morning the patient takes 20-minute naps to measure the level of daytime sleepiness using a recording technique similar to that of the all-night study When five naps are completed the sleep study ends Candidates may also undergo a lumbar puncture spinal tap to check for certain chemicals in the spinal fluid that might be related to fatigue and to look for possible causes of post-polio syndrome This procedure is optional For the lumbar puncture a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord A small amount of fluid is collected through the needle
Patients enrolled in the study will complete a sleep diary during the entire study period They will be randomly assigned to one of two treatment groups-Modafinil or placebo-for 6 weeks followed by a 2-week washout period with no medication and then a crossover phase in which patients who took Modafinil for the first 6 weeks now take placebo and those who took placebo now take Modafinil
At the first study visit patients will be given a supply of study medication and have blood drawn They will take one pill twice a day during both study phases In both study phases evaluations will be done 3 and 6 weeks after starting the medication The evaluations include filling out the same forms completed at the screening visit a review of drug side effects and a review of medical problems since the last study visit At the 6-week visit blood is also drawn
Detailed Description:
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 400000 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 patients serum and CSF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0276 | None | None | None |