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NCT00049803 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
A Phase 3 study, sponsored by Orphan Medical.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT00049803 is a Phase 3 study that has completed, run by Orphan Medical. The registered enrollment target is 200 participants.
The verdict
NCT00049803, a Phase 3 study, has completed, sponsored by Orphan Medical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study Summary
The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week period. During the trial, narcolepsy symptoms will be evaluated. Participants are allowed to continue using stimulant medications at constant doses during the study. A total of 1 to 3 daytime visits in addition to 4 overnight visits to the sleep center will be required to complete the study.
Interventions
- DRUG sodium oxybate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2000-12 |
| Est. Completion | 2004-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00049803
The ClinicalTrials.gov registry entry for NCT00049803 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orphan Medical, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which sodium oxybate is the first listed.
NCT00049803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00049803 about?
NCT00049803 is a clinical study titled "Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients". The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week period. During the trial, narcolepsy symptoms will be evaluated. Partici...
What is the current status of trial NCT00049803?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2000-12. Estimated completion is 2004-04.
What interventions are being tested in trial NCT00049803?
The interventions under investigation include: sodium oxybate (DRUG).
Who is sponsoring clinical trial NCT00049803?
This trial is sponsored by Orphan Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
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