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Sponsored by: |
Orphan Medical |
Information provided by: | Orphan Medical |
ClinicalTrials.gov Identifier: | NCT00132873 |
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.
Condition | Intervention | Phase |
Narcolepsy |
Drug: Xyrem (sodium oxybate) oral solution |
Phase III |
MedlinePlus related topics: | Club Drugs |
Drug Information available for: | Sodium oxybate |
Study Type: | Interventional |
Study Design: | Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy |
Estimated Enrollment: | 70 |
Study Start Date: | October 2004 |
Study Completion Date: | December 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Responsible Party: | Jazz Pharmaceuticals, Inc ( Senir Director, Clinical Development - Psychiatry ) |
Study ID Numbers: | OMC-SXB-27 |
First Received: | August 18, 2005 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00132873 |
Health Authority: | United States: Food and Drug Administration |
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