Overview
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
Status:
Completed
Completed
Trial end date:
2007-12-01
2007-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jazz PharmaceuticalsTreatments:
Pharmaceutical Solutions
Sodium Oxybate
Criteria
Inclusion Criteria:- Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
- Signed and dated an informed consent