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NCT00324896 · ClinicalTrials.gov registry record · Phase 3
Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone
A Phase 3 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT00324896 is a Phase 3 study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 30 participants.
The verdict
NCT00324896, a Phase 3 study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study 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
Interventions
- OTHER placebo
- DRUG eszopiclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-05 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00324896
The ClinicalTrials.gov registry entry for NCT00324896 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Medicine and Dentistry of New Jersey, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00324896 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00324896 about?
NCT00324896 is a clinical study titled "Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone". 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 imp...
What is the current status of trial NCT00324896?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2006-05. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00324896?
The interventions under investigation include: placebo (OTHER), eszopiclone (DRUG).
Who is sponsoring clinical trial NCT00324896?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
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