drugset / Trial / NCT00132873

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

NCT00132873

Phase 3 Completed 59 enrolled Jazz Pharmaceuticals
Non-randomizedSingle-groupOpen-label

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.

Timeline

Start
2004-10
Primary completion
2007-09
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Oxybate Unknown Oral

Indications