Eszopiclone for Improving Sleep in Multiple Sclerosis (MS)
Public ClinicalTrials.gov record NCT00594087. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Eszopiclone for Improving Sleep Continuity in MS Patients With Sleep Disturbances and Its Impact on Daytime Fatigue
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 receive the medication, at the first follow up visit and when you end the study.
Study identification
- NCT ID
- NCT00594087
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2006
- Primary completion
- Apr 30, 2008
- Completion
- May 31, 2008
- Last update posted
- Jan 4, 2009
2006 – 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Vermont | Burlington | Vermont | 05401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00594087, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 4, 2009 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00594087 live on ClinicalTrials.gov.