Number of Subjects with treatment-emergent adverse events.
Trial of Xyrem® (Sodium Oxybate) 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.
Condition or Disease
- Narcolepsy
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 12 Years and older (Child, Adult, Older Adult) |
| Enrollment: | 59 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | Non-Randomized |
Masking |
|
Clinical Trial Dates
| Start date: | Oct 01, 2004 | |
|---|---|---|
| Primary Completion: | Sep 01, 2007 | ACTUAL |
| Completion Date: | Dec 01, 2007 | ACTUAL |
| Study First Posted: | Aug 22, 2005 | ESTIMATED |
| Results First Posted: | Nov 25, 2013 | ESTIMATED |
| Last Updated: | Sep 18, 2013 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
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.
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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 12 |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
* Signed and dated an informed consent
* Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
* Signed and dated an informed consent
Primary Outcomes
-
-
Average Respiratory Rate at 1 year.
More Details
| NCT Number: | NCT00132873 |
|---|---|
| Other IDs: | OMC-SXB-27 |
| Study URL: | https://clinicaltrials.gov/study/NCT00132873 |
Last updated: Sep 29, 2023