Phase 3
N=59
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
Narcolepsy
Bottom Line
View on ClinicalTrials.gov: NCT00132873 ↗Enrolled (actual)
59
Serious AEs
19.0%
Results posted
Nov 2013
Primary outcome: Primary: Adverse Experiences — 54 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Xyrem (sodium oxybate) oral solution (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Experiences |
54 | — |
| PRIMARY Vital Signs |
14.0 | — |
Summary
This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.
Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.
Eligibility Criteria
Inclusion Criteria
- Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
- Signed and dated an informed consent
Data sourced from ClinicalTrials.gov (NCT00132873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.