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NCT00498485 · ClinicalTrials.gov registry record · Phase 4
Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome
A Phase 4 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Terminated
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT00498485 is a Phase 4 study that was terminated before completion, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 17 participants.
The verdict
NCT00498485, a Phase 4 study, was terminated before completion, sponsored by University of Medicine and Dentistry of New Jersey.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce the sleep disturbances of CFS leading to better sleep with less fatigue. Its ability to produce the rapid onset of deep sleep is a reason it became a street drug, but its availability is currently limited via distribution through a single centralized pharmacy. Xyrem has been successfully used based on results from a study on patients with fibromyalgia (FM), an ailment closely resembling CFS. However, in that study, the researchers provided no information as to whether patients had FM alone or FM plus CFS. Thus, it is not clear from this study just which patient may be helped. I have prescribed Xyrem for patients who have both FM and CFS with good results. In this study, funded by the company that makes Xyrem, I propose testing the drug's efficacy on patients with CFS alone - that is, they do not have fibromyalgia. Volunteers for this study will complete paper and pencil questionnaires about their symptoms as well as a computerized test to assess their degree of brain fog. They will then be randomly assigned to one of two groups, placebo or drug. Volunteers will not know what group they are in until the end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks identical to the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will be told to skip taking the second dose. We will call patients weekly to see how they are doing on the "drug." If they have tolerable side effects or report significant im
Interventions
- DRUG Placebo
- DRUG Sodium Oxybate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00498485
The ClinicalTrials.gov registry entry for NCT00498485 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 17 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.
NCT00498485 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00498485 about?
NCT00498485 is a clinical study titled "Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome". Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce the sleep disturban...
What is the current status of trial NCT00498485?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2007-05. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00498485?
The interventions under investigation include: Placebo (DRUG), Sodium Oxybate (DRUG).
Who is sponsoring clinical trial NCT00498485?
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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