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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00324896
• Date of registration: 09/05/2006
• Prospective Registration: No
• Primary sponsor: University of Medicine and Dentistry of New Jersey
• Public title: Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone
• Scientific title: Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone
• Date of first enrolment: May 2006
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00324896
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Matthew Menza, MD
• Affiliation: Rutgers, The State University of New Jersey

Key inclusion & exclusion 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.



Age minimum: 35 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Insomnia

Intervention(s)

Other: placebo

Drug: eszopiclone

Primary Outcome(s)

TST [Time Frame: 6 weeks]

Secondary Outcome(s)

WASO [Time Frame: 6 weeks]

Secondary ID(s)

5581

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sunovion

Results

• Results available: Yes
• Date Posted: 31/05/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00324896