Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone
Condition: Parkinson's Disease; Insomnia
MeSH terms: Parkinson Disease; Sleep Initiation and Maintenance Disorders
Intervention: eszopiclone; placebo
Intervention description: eszopiclone; matching placebo administered at night
Intervention MeSH terms: Eszopiclone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 35 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's; insomnia; drug; eszopiclone; placebo

Summary:

      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
    

Eligibility 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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