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

NCT00324896 | Completed Phase 3 Results

• 1 other identifier: 5581
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Parkinson's Disease; Insomnia

Keywords

Parkinson's; insomnia; drug; eszopiclone; placebo

Outcome Measures

Primary Outcomes (1)

• TST

  Total sleep time in hours

  6 weeks

Secondary Outcomes (1)

• WASO

  6 weeks

Study Arms (2)

eszopiclone

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

Those randomly assigned to matching placebo, took their dose each night at bedtime

Other: placebo

Interventions

eszopiclone DRUG

eszopiclone

Also known as: Lunesta 2 - 3 mg q HS

eszopiclone

placebo OTHER

matching placebo administered at night

placebo

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patients aged 35-85 years.
• Patients must have completed at least the 9th grade and be fluent in English.
• 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.
• Antidepressants will be allowed if the patient has been on a stable dose for at least one month.
• Benzodiazepines will be allowed if taken during the day prior to 6pm and it is not taken as a sleep aid.
• 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.

You may not qualify if:

• 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).
• 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).
• No significant dementia. Significant dementia is operationalized as a score of less than 26 on the Mini-Mental State Examination (MMSE).
• Insomnia is not primarily due to serious depression or anxiety in the opinion of the investigator.
• Any current (within three months) diagnosis of alcohol or substance abuse/dependence (with the exception of nicotine dependence).
• 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.
• Sleep medication that the patient is on during screening will be tapered prior to randomization.
• Any unstable medical disorder that would interfere with the study.
• Patients with a known history of non-response or lack of toleration to adequate doses of zolpidem or trazodone.
• Patients currently receiving CBT for insomnia.
• Patients who are unable to be maintained on their current dose of PD medications throughout the trial.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (4)

Fusion Sleep Center

Suwanee, Georgia, 30024, United States

Location

The New Jersey Neuroscience Institute

Edison, New Jersey, 08818, United States

Location

UMDNJ Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

Location

University of Pennsylvania Medical School

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Menza M, Dobkin RD, Marin H, Gara M, Bienfait K, Dicke A, Comella CL, Cantor C, Hyer L. Treatment of insomnia in Parkinson's disease: a controlled trial of eszopiclone and placebo. Mov Disord. 2010 Aug 15;25(11):1708-14. doi: 10.1002/mds.23168.

  PMID: 20589875 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Limitations and Caveats

This was only a 6-week trial with small group of participants.

Results Point of Contact

• Title: Matthew Menza, MD
• Organization: UMDNJ - RWJMS

menza@umdnj.edu

732-235-4440

Study Officials

• Matthew Menza, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 11, 2006
• Study Start: May 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 31, 2013
• Results First Posted: May 31, 2013

Record last verified: 2013-04

Locations

US (4)