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| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
Sepracor, Inc. |
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00324896 |
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 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-Site, Placebo-Controlled Study of Eszopiclone |
| Estimated Enrollment: | 70 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
eszopiclone: Experimental
eszopiclone
|
Drug: eszopiclone
eszopiclone
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 38 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Patients who are unable to be maintained on their current dose of PD medications throughout the trial.
-
Contacts and Locations| Contact: Matthew Menza, MD | 732-235-4440 | menza@umdnj.edu |
| Contact: Allison Dicke | 732-235-5886 | dickeaf@umdnj.edu |
| United States, Georgia | |
| Fusion Sleep Center | Recruiting |
| Suwanee, Georgia, United States, 30024 | |
| Contact: Jeffrey Durmer, MD 678-990-3962 jdurmer@fusionsleep.com | |
| Contact: Michael Decker 678 990 3962 mdecker@fusionsleep.com | |
| Principal Investigator: Jeffrey Durmer, MD | |
| United States, New Jersey | |
| The New Jersey Neuroscience Institute | Completed |
| Edison,, New Jersey, United States, 08818 | |
| UMDNJ Robert Wood Johnson Medical School | Recruiting |
| Piscataway, New Jersey, United States, 08854 | |
| Contact: Matthew Menza, MD 732-235-5586 menza@umdnj.edu | |
| Contact: Allison Dicke 732-235-5586 dickeaf@umdnj.edu | |
| Principal Investigator: Matthew Menza, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania Medical School | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Charles Cantor, M.D. 215-573-9970 crcantor@pahosp.com | |
| Contact: Fran Pack 215-573-9970 fmpack@mail.med.upenn.edu | |
| Principal Investigator: Charles Cantor, M.D. | |
| Principal Investigator: | Matthew Menza, MD | University of Medicine and Dentistry New Jersey |
More Information
| Responsible Party: | RWJMS - UMDNJ ( Matthew Menza ) |
| Study ID Numbers: | 5581 |
| Study First Received: | May 9, 2006 |
| Last Updated: | March 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00324896 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Parkinson's insomnia drug eszopiclone placebo |
|
Sleep Initiation and Maintenance Disorders Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Dyssomnias Sleep Disorders Brain Diseases |
Neurodegenerative Diseases Sleep Disorders, Intrinsic Parkinson Disease Movement Disorders Mental Disorders Parkinsonian Disorders |