At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 59 enrolled
Drug / intervention
Xyrem (sodium oxybate) oral solutiondrug
Likely dose
Xyrem (sodium oxybate) oral solution at dose established in prior OMC-SXB-7 trialAI-extracted
Key inclusion· 1
- ✓Remained on satisfactory treatment with Xyrem therapy in the OMC-SXB-7 trial
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy
In Brief
A Phase 3 clinical trial evaluating Xyrem (sodium oxybate) oral solution for Narcolepsy. Completed, enrolled 59 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy
CountriesCanada
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2004
First PostedAug 2005
Primary CompletionSep 2007
Study CompletionDec 2007
TodayJul 2026
First PostedAug 22, 2005
Enrollment StartOct 1, 2004
Primary CompletionSep 1, 2007
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.9 years ago
Interventions
Xyrem (sodium oxybate) oral solutiondrug
Xyrem (sodium oxybate) oral solution