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NCT00594087 · ClinicalTrials.gov registry record · NA
Eszopiclone for Improving Sleep in Multiple Sclerosis (MS)
A NA study, sponsored by University of Vermont.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT00594087 is a NA study that has completed, run by University of Vermont. The registered enrollment target is 30 participants.
The verdict
NCT00594087, a NA study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if people with multiple sclerosis (MS) and fatigue have disrupted sleep, as was suggested in previous studies, and whether treating the disruptions of sleep improves the fatigue. Eszoplicone, a new drug FDA approved for the treatment of insomnia, will be used to control sleep disturbances in MS patients with fatigue. The study will last 7 weeks, 5 of which will involve being on medication. You will take eszopiclone or placebo (sugar pill), keep a sleep diary and wear an actigraph, a device about the size of a digital watch that monitors and records sleep activity. You will randomly be chosen to get either placebo or medication. Half the subjects will get placebo and half eszopiclone. The decision will be made by a pharmacist (who does not know you) according to a randomization table. Neither you nor the investigating physician will know whether you are on sugar pill or medication. At both the beginning and the conclusion of the study you will be asked to fill out 2 questionnaires to evaluate fatigue and depression and undergo some memory and speech tests. The testing will take about 2 hours. Actigraphy is a wrist-worn, watch like device that records activity during waking and sleeping without application of any sensors. It consists of a movement detector, so it can record movement and non-movement data for a week or two. You should wear it continuously during wakefulness and sleep as you go about routine daily activities. You should only take it off if you are going to shower, bathe or swim. A sleep log is a graph on which, for 2 to 3 weeks, you will record bedtime, approximate sleep time, times and duration of awakenings during the sleep period, final awakening time, and naps taken during the day to the best of your knowledge. You will also be asked to avoid getting pregnant. If you are a woman who may have the potential to get pregnant then a pregnancy test may be performed at the beginning of the study, before you recei
Interventions
- OTHER placebo
- DRUG eszopiclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00594087
The ClinicalTrials.gov registry entry for NCT00594087 describes a study currently listed as completed, categorized as NA. 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 University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00594087 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00594087 about?
NCT00594087 is a clinical study titled "Eszopiclone for Improving Sleep in Multiple Sclerosis (MS)". The purpose of this study is to determine if people with multiple sclerosis (MS) and fatigue have disrupted sleep, as was suggested in previous studies, and whether treating the disruptions of sleep improves the fatigue. Eszoplicone, a new drug FDA approved for the treatment of insomnia, will be us...
What is the current status of trial NCT00594087?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2006-12. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00594087?
The interventions under investigation include: placebo (OTHER), eszopiclone (DRUG).
Who is sponsoring clinical trial NCT00594087?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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