Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132873
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2005-08-18
Brief Title:
Trial of Xyrem Sodium Oxybate for the Treatment of Narcolepsy
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
Long-Term Open-Label Multi-Center Extension Trial of Xyrem Sodium Oxybate Oral Solution for the Treatment of Narcolepsy
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None