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Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone

This study has been completed.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ) Identifier:
First received: May 9, 2006
Last updated: April 24, 2013
Last verified: April 2013
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
Drug: eszopiclone
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):

Primary Outcome Measures:
  • TST [ Time Frame: 6 weeks ]
    Total sleep time in hours

Secondary Outcome Measures:
  • WASO [ Time Frame: 6 weeks ]
    Wake after sleep onset in minutes

Enrollment: 30
Study Start Date: May 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eszopiclone
eszopiclone. Those under 65yo received 3mg of eszoplicone ( or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone ( or randomized to matching placebo)taken each night at bedtime
Drug: eszopiclone
Other Name: Lunesta 2 - 3 mg q HS
Placebo Comparator: placebo
Those randomly assigned to matching placebo, took their dose each night at bedtime
Other: placebo
matching placebo administered at night

  Show Detailed Description


Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00324896

United States, Georgia
Fusion Sleep Center
Suwanee, Georgia, United States, 30024
United States, New Jersey
The New Jersey Neuroscience Institute
Edison,, New Jersey, United States, 08818
UMDNJ Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
United States, Pennsylvania
University of Pennsylvania Medical School
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Principal Investigator: Matthew Menza, MD Rutgers, The State University of New Jersey
  More Information

Responsible Party: University of Medicine and Dentistry of New Jersey Identifier: NCT00324896     History of Changes
Other Study ID Numbers: 5581
Study First Received: May 9, 2006
Results First Received: January 23, 2013
Last Updated: April 24, 2013

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):

Additional relevant MeSH terms:
Parkinson Disease
Sleep Initiation and Maintenance Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on May 25, 2017