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NCT00462254 · ClinicalTrials.gov registry record · Phase 4
Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
A Phase 4 study, sponsored by Southern California Institute for Research and Education.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT00462254: Clinical Trial Phase 4 study, sponsored by Southern California Institute for Research and Education.
NCT00462254 is a Phase 4 study that was terminated before completion, run by Southern California Institute for Research and Education. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00462254, a Phase 4 study, was terminated before completion, sponsored by Southern California Institute for Research and Education.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
Patients with Parkinson's disease represent a significant proportion of VA elderly patients. Sleep disturbances and caregiver burnout association with this condition represent a significant problem. In this study, the investigators propose to perform an evaluation of a fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinson's disease. The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients with Parkinson's disease while indirectly improving the quality of life for the patients and caregivers. The investigators further hypothesize that these changes will occur through restructuring and normalization of the sleep architecture.
Interventions
- DRUG Ramelteon
- DRUG ROZEREM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
Why NCT00462254 stopped before completion
NCT00462254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Ramelteon is the first listed.
NCT00462254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00462254 about?
NCT00462254 is a clinical study titled "Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease". Patients with Parkinson's disease represent a significant proportion of VA elderly patients. Sleep disturbances and caregiver burnout association with this condition represent a significant problem. In this study, the investigators propose to perform an evaluation of a fixed doe of ramelteon on slee...
What is the current status of trial NCT00462254?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2007-06. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00462254?
The interventions under investigation include: Ramelteon (DRUG), ROZEREM (DRUG).
Who is sponsoring clinical trial NCT00462254?
This trial is sponsored by Southern California Institute for Research and Education, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00462254's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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