Relapsing Remitting Multiple SclerosisNCT00594087
Eszopiclone for Improving Sleep in Multiple Sclerosis (MS)
A study testing eszopiclone in people with Relapsing Remitting Multiple Sclerosis and Sleep Initiation and Maintenance Disorders, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis, Sleep Initiation and Maintenance Disorders, Fatigue
- What is being tested?
- eszopiclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects ages 18 - 64 inclusive.
- Female subjects must be surgically sterile, at least 1 year post menopausal, or agree to use a medically acceptable form of birth control throughout the study and for 2 weeks following the last study visit.
- Diagnosis of relapsing-remitting MS
- MS and MS symptoms must be stable (no evidence of worsening or of exacerbations) for at least 3 months prior to screening visit. The date of last recorded exacerbation will be captured at enrollment.
- EDSS score </= 5
- Diagnosis of fatigue based on fatigue questionnaires, specifically the Fatigue Descriptive Scale (FDS) in which a score of five higher is considered to be indicative of fatigue (range 0-13)
- Actigraphic evidence of sleep disturbances defined a sleep latency of 30 minutes or longer, and/or total sleep time of less than 6.5 hours.
- Finally a CESD score of under 20 (20 or more is suggestive of Major Depression)
Who cannot join
- Pregnant and breast-feeding women
- Subjects with any history of substance and/or alcohol abuse or dependence within 5 years prior to screening.
- Subjects who are the sole caretaker of infants and young children because they may be too sedated in the middle of the night in case they need to get up and take care of an infant or a child.
- Patients with past history of allergy to eszopiclone or Zopiclone.
- Patients with primary progressive Multiple Sclerosis.
- Subjects with impaired cognition as measured by Mini Mental State Examination (MMSE) score of 26 or less
Show all 9Show fewer
- Subjects with history suggestive of another primary sleep disorder including OSAS, PLMS, or RLS
- Any patients with any known active DSM-IV axis I (i.e. schizophrenia, etc) or any other psychiatric disorder which would compromise the investigator's ability to evaluate the safety and efficacy of the study medication.
- Patients 65 years old and older because the drug at the 3 mg dose has not been FDA approved to be used in this age group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eszopiclone for Improving Sleep Continuity in MS Patients With Sleep Disturbances and Its Impact on Daytime Fatigue
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.
Read the 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis, Sleep Initiation and Maintenance Disorders, Fatigue
- Being tested
- eszopiclone, placebo
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eszopicloneDrug
Also called Lunesta
eszopiclone 2mg or 3mg at bedtime
placeboOther
2 mg or 3 mg at bedtime
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lunesta 2 or 3 mg Receives: Drug: eszopiclone |
| 2 | Placebo comparator | Placebo 2mg or 3 mg Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Measured: 7 weeks
Secondary outcomes (2)
Sleep continuity
Measured: 7 weeks
Neurocognitive function
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startDec 2006
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Investigators
- Hrayr Attarian, MD, Principal investigator, UVM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594087
- Sponsor's protocol ID
- CHRMS 05-255
- Other IDs
- Sepracor Study ESRC016
- Status last verified
- Dec 2008
- First submitted
- 3 Jan 2008
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15096400Fisk 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.
PubMed 8148458Jean-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.
PubMed 10978477Iriarte 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.
PubMed 10096097
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eszopiclone for Improving Sleep Continuity in MS Patients With Sleep Disturbances and Its Impact on Daytime Fatigue
- ClinicalTrials.gov ID
- NCT00594087
- Acronym / sponsor ID
- CHRMS 05-255
- Conditions
- Relapsing Remitting Multiple Sclerosis, Sleep Initiation and Maintenance Disorders, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: eszopicloneLunesta 2 or 3 mg |
| 2 | Placebo comparator | Other: placeboPlacebo 2mg or 3 mg |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female subjects ages 18 - 64 inclusive.
- Female subjects must be surgically sterile, at least 1 year post menopausal, or agree to use a medically acceptable form of birth control throughout the study and for 2 weeks following the last study visit.
- Diagnosis of relapsing-remitting MS
- MS and MS symptoms must be stable (no evidence of worsening or of exacerbations) for at least 3 months prior to screening visit. The date of last recorded exacerbation will be captured at enrollment.
- EDSS score </= 5
Key exclusion criteria (9 listed)
- Pregnant and breast-feeding women
- Subjects with any history of substance and/or alcohol abuse or dependence within 5 years prior to screening.
- Subjects who are the sole caretaker of infants and young children because they may be too sedated in the middle of the night in case they need to get up and take care of an infant or a child.
- Patients with past history of allergy to eszopiclone or Zopiclone.
- Patients with primary progressive Multiple Sclerosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eszopicloneAlso: Lunestaeszopiclone 2mg or 3mg at bedtime | Drug | 1 |
| placebo2 mg or 3 mg at bedtime | Other | 2 |
Primary outcome
Fatigue
Time frame: 7 weeks
2 secondary outcomes
Sleep continuity
Time frame: 7 weeks
Neurocognitive function
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
- Background: PubMed 15096400Attarian 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.
- Background: PubMed 8148458Fisk 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.
- Background: PubMed 10978477Jean-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.
- Background: PubMed 10096097Iriarte 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.
- University of VermontLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hrayr Attarian, MD principal investigator
UVM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eszopiclone in people with Relapsing Remitting Multiple Sclerosis and Sleep Initiation and Maintenance Disorders, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594087, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2009.