Trial record 2 of 13 for:    "Post Polio syndrome"

Modafinil to Treat Fatigue in Post-Polio Syndrome

This study has been terminated.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00067496
First received: August 20, 2003
Last updated: August 26, 2008
Last verified: May 2005
  Purpose

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 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.


Condition Intervention Phase
Postpoliomyelitis Syndrome
Drug: Modafinil
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Modafinil in the Treatment of Fatigue in Post-Polio Syndrome

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 30
Study Start Date: August 2003
Estimated Study Completion Date: August 2006
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients will have to meet the clinical criteria for the diagnosis of PPS, have fatigue as a major complaint, and be 18 years or older, of either sex.

EXCLUSION CRITERIA:

Sensitivity to modafinil.

A score of 34 or below on the FSS.

Suffer from depression (BDI-II score of 31 or higher) severe enough to compound the fatigue evaluation.

Another general medical condition that might produce fatigue to a sufficient degree to compound and confuse the assessment of fatigue due to PPS.

Use of a drug known to cause a clinically significant interaction with modafinil.

Presence of sleep disorder suggested by Epworth Sleepiness Scale (score of 18 or higher), patient history, sleep diary or polysomnogram.

Pregnancy .

Breastfeeding.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067496

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00067496     History of Changes
Other Study ID Numbers: 030276, 03-N-0276
Study First Received: August 20, 2003
Last Updated: August 26, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pain
Weakness
Depression
Poliomyelitis
Sleep Apnea
Post-Polio Syndrome
PPS

Additional relevant MeSH terms:
Postpoliomyelitis Syndrome
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neurodegenerative Diseases
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 22, 2014