Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy

Jazz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Narcolepsy

Treatments: Drug: Xyrem (sodium oxybate) oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00132873

OMC-SXB-27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
• Signed and dated an informed consent