Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
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
Phase:
Phase 3
Details
Lead Sponsor:
University of Medicine and Dentistry of New Jersey