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NCT00066170 · ClinicalTrials.gov registry record · Phase 3
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
NCT00066170 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 231 participants.
The verdict
NCT00066170, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
Study Summary
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.
Interventions
- DRUG Xyrem
- DRUG Xyrem Placebo
- DRUG Modafinil at established dose
- DRUG Modafinil (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2003-04 |
| Est. Completion | 2004-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00066170
The ClinicalTrials.gov registry entry for NCT00066170 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Xyrem is the first listed.
NCT00066170 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00066170 about?
NCT00066170 is a clinical study titled "Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy". This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep...
What is the current status of trial NCT00066170?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2003-04. Estimated completion is 2004-11.
What interventions are being tested in trial NCT00066170?
The interventions under investigation include: Xyrem (DRUG), Xyrem Placebo (DRUG), Modafinil at established dose (DRUG), Modafinil (Placebo) (DRUG).
Who is sponsoring clinical trial NCT00066170?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
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