Status:
COMPLETED
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Narcolepsy
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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. ...
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 parti...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
- Signed and dated an informed consent
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00132873
Start Date
October 1 2004
End Date
December 1 2007
Last Update
November 25 2013
Active Locations (1)
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1
Brain and Sleep Diagnostic Centre
Toronto, Ontario, Canada, M8X 2W2