Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
- Conditions
- Narcolepsy
- Registration Number
- NCT00132873
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief 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.
- Detailed Description
This trial will be conducted as 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
- Signed and dated an informed consent
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Vital Signs At 1 year Average Respiratory Rate at 1 year.
Adverse Experiences continuous Number of Subjects with treatment-emergent adverse events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Brain and Sleep Diagnostic Centre
🇨🇦Toronto, Ontario, Canada