NCT00132873

Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy

Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	Xyrem (sodium oxybate) oral solution	Xyrem (sodium oxybate) oral solution

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-09-01
• Completion: 2007-12-01
• First posted: 2005-08-22
• Last updated: 2013-11-25
• Results posted: 2013-11-25

Locations

1 site across 1 country: Canada