Narcolepsy Clinical Trial
Official title:
Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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||
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