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| ID | Type | Description | Link |
|---|---|---|---|
| Sepracor Study ESRC016 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Lunesta 2 or 3 mg |
|
| 2 | Placebo Comparator | Placebo 2mg or 3 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eszopiclone | Drug | eszopiclone 2mg or 3mg at bedtime |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep continuity | 7 weeks | |
| Neurocognitive function | 7 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hrayr Attarian, MD | UVM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15096400 | Background | Attarian HP, Brown KM, Duntley SP, Carter JD, Cross AH. The relationship of sleep disturbances and fatigue in multiple sclerosis. Arch Neurol. 2004 Apr;61(4):525-8. doi: 10.1001/archneur.61.4.525. | |
| 8148458 | Background | Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79. |
| Label | URL |
|---|---|
| University of Vermont | View source |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| placebo | Other | 2 mg or 3 mg at bedtime |
|
| 10978477 | Background | Jean-Louis G, Mendlowicz MV, Gillin JC, Rapaport MH, Kelsoe JR, Zizi F, Landolt H, von Gizycki H. Sleep estimation from wrist activity in patients with major depression. Physiol Behav. 2000 Jul 1-15;70(1-2):49-53. doi: 10.1016/s0031-9384(00)00228-6. |
| 10096097 | Background | Iriarte J, Katsamakis G, de Castro P. The Fatigue Descriptive Scale (FDS): a useful tool to evaluate fatigue in multiple sclerosis. Mult Scler. 1999 Feb;5(1):10-6. doi: 10.1177/135245859900500103. |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |