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NCT01143428 · ClinicalTrials.gov registry record
Oxidative Stress in Motor Neuron Disease: COSMOS Add-On Study
A clinical trial of Motor Neuron Disease and Primary Lateral Sclerosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 10
- Enrollment target
- 1
- Study location
NCT01143428: Completed study of Motor Neuron Disease and Primary Lateral Sclerosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT01143428 is a study of Motor Neuron Disease and Primary Lateral Sclerosis that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 10 participants, below the 530-participant average among 17 other Motor Neuron Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01143428, a study of Motor Neuron Disease and Primary Lateral Sclerosis, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Primary lateral sclerosis (PLS) is a disorder in which nerve cells in the brain that control movement degenerate. The cause of PLS is not known, but some research has suggested that environmental factors that produce oxidative stress trigger PLS in people who carry certain genes. Oxidative stress is caused when the body makes chemicals called "free radicals" faster than its natural systems can break them down. Oxidative stress can be triggered by exposures to chemicals related to the bodily effects of lead, smoking, alcohol consumption, physical activity, and psychological stress. Chemicals produced by the body during oxidative stress can be measured in the blood and urine. Researchers are interested in studying the physical, neurological, and chemical effects of PLS to better understand the effects of oxidative stress on the disorder. Objectives: \- To study the relation of oxidative stress to the diagnosis and progression of motor neuron disease. Eligibility: \- Individuals 20 years of age or older who have been diagnosed with PLS, and have had symptoms of PLS for at least 5 but not more than 8 years and been previously enrolled in 01-N-0145 Screening: Neurologic Disorders with Muscle Stiffness Design: * Participants will have an initial study visit and three follow-up visits. Each visit will require approximately 3 days of testing at the National Institutes of Health Clinical Center. * As part of this study, participants will have the following tests and procedures: * Neurological examination to test muscle strength, sensation, coordination, and reflexes, as well as clarity of speech * Tests of memory, attention, concentration, and thinking * Surveys on oxidative stress, including questions on life, mood, jobs held, and habit * Electromyography to record the electrical activity of muscles * Transcranial magnetic stimulation to measure electrical activity translated from their brain to the muscles * Blood, urine, and skin biopsy samples for t
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-05-13 |
| Est. Completion | 2015-08-03 |
What the finished NCT01143428 record still lists
NCT01143428 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 530-participant average among 17 other Motor Neuron Disease trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Motor Neuron Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01143428 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01143428 about?
NCT01143428 is a clinical study titled "Oxidative Stress in Motor Neuron Disease: COSMOS Add-On Study". Background: \- Primary lateral sclerosis (PLS) is a disorder in which nerve cells in the brain that control movement degenerate. The cause of PLS is not known, but some research has suggested that environmental factors that produce oxidative stress trigger PLS in people who carry certain genes. Oxi...
What is the current status of trial NCT01143428?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2010-05-13. Estimated completion is 2015-08-03.
What conditions does trial NCT01143428 study?
This clinical trial studies the following conditions: Motor Neuron Disease, Primary Lateral Sclerosis.
Who is sponsoring clinical trial NCT01143428?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01143428 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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