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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Jazz Pharmaceuticals

Current Primary Outcome:

• Adverse Experiences [ Time Frame: continuous ]
  Number of Subjects with treatment-emergent adverse events.
• Vital Signs [ Time Frame: At 1 year ]
  Average Respiratory Rate at 1 year.

Original Primary Outcome:

• Adverse Experiences
• Vital Signs

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Jazz Pharmaceuticals

Dates:
Date Received: August 18, 2005
Date Started: October 2004
Date Completion:
Last Updated: September 18, 2013
Last Verified: September 2013