CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
eszopiclone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00324896
NCT00324896Phase 3Completed

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

University of Medicine and Dentistry of New Jersey·interventional·Posted May 11, 2006·Updated May 31, 2013

In Brief

A Phase 3 clinical trial evaluating eszopiclone and placebo for Parkinson's Disease and Insomnia. Completed, enrolled 30 participants across 4 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 11, 2006
Enrollment StartMay 1, 2006
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.1 years ago

Interventions

eszopiclonedrug

eszopiclone

placeboother

matching placebo administered at night