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

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier:
NCT00324896
First received: May 9, 2006
Last updated: April 24, 2013
Last verified: April 2013
  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
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • TST [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Total sleep time in hours


Secondary Outcome Measures:
  • WASO [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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
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

  Eligibility

Ages Eligible for Study:   35 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

Locations
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 New Jersey
Sunovion
Investigators
Principal Investigator: Matthew Menza, MD Rutgers, The State University of New Jersey
  More Information

Publications:
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
Parkinson's
insomnia
drug
eszopiclone
placebo

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
Dyssomnias
Sleep Disorders
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014