Eszopiclone for Improving Sleep in Multiple Sclerosis (MS)
Condition: Relapsing Remitting Multiple Sclerosis; Sleep Initiation and Maintenance Disorders; Fatigue
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sleep Initiation and Maintenance Disorders; Sclerosis; Fatigue
Study type: Interventional

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 receive the
      medication, at the first follow up visit and when you end the study.
    

Detailed description: 
      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.
    

Intervention name(s): eszopiclone; placebo
Intervention type(s): Drug; Other
Intervention description(s): eszopiclone 2mg or 3mg at bedtime; 2 mg or 3 mg at bedtime
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment