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Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-Site, Placebo-Controlled Study of Eszopiclone
This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, March 2009
First Received: May 9, 2006   Last Updated: March 4, 2009   History of Changes
Sponsor: University of Medicine and Dentistry New Jersey
Collaborator: Sepracor, Inc.
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00324896
  Purpose

Parkinson's disease (PD) is the second most common neurodegenerative disease in the US, affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD complain of sleep disturbances, typically sleep fragmentation. Despite the high prevalence of sleep problems and their impact on the life of these individuals, there has been, until recently, little research focus on the problem. This will be a multi-site, double blind, placebo-controlled, two arm, parallel group, fixed-dose trial which will last 6 weeks. Seventy patients at four sites (30 at the PI's site and a total of 40 patients at three external sites) will be equally randomized to eszopiclone or placebo. The primary hypothesis is that eszopiclone will be superior to placebo for the treatment of insomnia in patients with Parkinson's disease


Condition Intervention Phase
Parkinson's Disease
Insomnia
Drug: eszopiclone
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-Site, Placebo-Controlled Study of Eszopiclone

Resource links provided by NLM:


Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • The primary outcome will be patient reported (diaries done daily and summed for weekly totals) Total Sleep Time (TST). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety will be monitored by adverse event reporting, rebound and tolerance. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A variety of secondary analyses will examine the relative effects of eszopiclone versus placebo on other sleep variables, as well as on measures of quality of life, daytime functioning, cognition and motor disability. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: May 2006
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
eszopiclone: Experimental
eszopiclone
Drug: eszopiclone
eszopiclone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   38 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Parkinson's disease by research criteria. Research criteria for PD include, (1) the presence of at least 2 of the following signs: resting tremor, cogwheel rigidity, bradykinesia, or postural reflex impairment, at least 1 of which must be either resting tremor or bradykinesia, (2) no other cause of parkinsonism, (3) no signs of more extensive neurodegeneration indicating atypical parkinsonism, and (4) a clear-cut response to levodopa or dopamine agonist.
  2. Sleep maintenance insomnia (at least 3 of 7 nights of at least 2 awakenings nightly, or a total sleep time of < 6.5 hours) or sleep latency insomnia (at least 3 of 7 nights of sleep latency > 30 minutes), as well as clinically significant daytime distress or impairment during the 2 week self assessment prior to baseline.
  3. Patients aged 35-85 years.
  4. Patients must have completed at least the 9th grade and be fluent in English.
  5. If a female of child bearing potential, the patient must be non-pregnant and either post-menopausal or using an approved birth control method. Patients must have a negative urine pregnancy test at the screen visit.
  6. Antidepressants will be allowed if the patient has been on a stable dose for at least one month.
  7. Benzodiazepines will be allowed if taken during the day prior to 6pm and it is not taken as a sleep aid.
  8. Other medications with CNS activity that the patient is on at screening, e.g., dopaminergic drugs, B-blockers, etc, will be kept constant throughout the acute phase.

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Exclusion Criteria:

  1. Evidence on PSG and symptoms or complaints (as defined below) of, significant sleep disordered breathing (central or obstructive apnea), periodic limb movement disorder (PLMD), or REM sleep behavior disorder (RBD).
  2. Significant sleep disordered breathing will be defined as an AHI > 15 events/hr of sleep and/or significant hypoxemia on screening PSG; significant PLMD will be defined as a PLM index > 25 events/hr of sleep on screening PSG; RBD will be defined based on presence of both clinical symptomatology (demonstrated injury to self or others during sleep) as well as PSG criteria (intermittent loss of REM atonia).
  3. No significant dementia. Significant dementia is operationalized as a score of less than 26 on the Mini-Mental State Examination (MMSE).
  4. Insomnia is not primarily due to serious depression or anxiety in the opinion of the investigator.
  5. Any current (within three months) diagnosis of alcohol or substance abuse/dependence (with the exception of nicotine dependence).
  6. Currently on psychotropic medications, other than antidepressants or benzodiazepines. If the patient is on other psychotropics, and can be safely removed from these medications at the time of initial screening, there will be a washout period prior to entering the study.
  7. Sleep medication that the patient is on during screening will be tapered prior to randomization.
  8. Any unstable medical disorder that would interfere with the study.
  9. Patients with a known history of non-response or lack of toleration to adequate doses of zolpidem or trazodone.
  10. Patients currently receiving CBT for insomnia.
  11. Patients who are unable to be maintained on their current dose of PD medications throughout the trial.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324896

Contacts
Contact: Matthew Menza, MD 732-235-4440 menza@umdnj.edu
Contact: Allison Dicke 732-235-5886 dickeaf@umdnj.edu

Locations
United States, Georgia
Fusion Sleep Center Recruiting
Suwanee, Georgia, United States, 30024
Contact: Jeffrey Durmer, MD     678-990-3962     jdurmer@fusionsleep.com    
Contact: Michael Decker     678 990 3962     mdecker@fusionsleep.com    
Principal Investigator: Jeffrey Durmer, MD            
United States, New Jersey
The New Jersey Neuroscience Institute Completed
Edison,, New Jersey, United States, 08818
UMDNJ Robert Wood Johnson Medical School Recruiting
Piscataway, New Jersey, United States, 08854
Contact: Matthew Menza, MD     732-235-5586     menza@umdnj.edu    
Contact: Allison Dicke     732-235-5586     dickeaf@umdnj.edu    
Principal Investigator: Matthew Menza, MD            
United States, Pennsylvania
University of Pennsylvania Medical School Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Charles Cantor, M.D.     215-573-9970     crcantor@pahosp.com    
Contact: Fran Pack     215-573-9970     fmpack@mail.med.upenn.edu    
Principal Investigator: Charles Cantor, M.D.            
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Sepracor, Inc.
Investigators
Principal Investigator: Matthew Menza, MD University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: RWJMS - UMDNJ ( Matthew Menza )
Study ID Numbers: 5581
Study First Received: May 9, 2006
Last Updated: March 4, 2009
ClinicalTrials.gov Identifier: NCT00324896     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:
Parkinson's
insomnia
drug
eszopiclone
placebo

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Dyssomnias
Sleep Disorders
Brain Diseases
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Parkinson Disease
Movement Disorders
Mental Disorders
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 27, 2009