ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
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, April 2007

Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
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

Genetics Home Reference related topics:   Parkinson disease   

MedlinePlus related topics:   Parkinson's Disease    Sleep Disorders   

ChemIDplus related topics:   Eszopiclone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo 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

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).
  • Safety will be monitored by adverse event reporting, rebound and tolerance.

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.

Estimated Enrollment:   70
Study Start Date:   May 2006
Estimated Study Completion Date:   May 2008

Show detailed description  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.

    -

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.

    -

  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

Study ID Numbers:   5581
First Received:   May 9, 2006
Last Updated:   April 27, 2007
ClinicalTrials.gov Identifier:   NCT00324896
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Sleep Disorders
Dyssomnias
Brain Diseases
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Parkinson Disease
Movement Disorders
Mental Disorders
Parkinsonian Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers