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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: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT00066170 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 231 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.
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 |
What the finished NCT00066170 record still lists
NCT00066170 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Xyrem is the first listed.
NCT00066170 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00066170's enrollment target sits among peer trials
231 1300th of 2000 higher than 697 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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