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

NCT ID: NCT00132873

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-12-31

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.

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.

Conditions

Narcolepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Xyrem (sodium oxybate) oral solution

Xyrem (sodium oxybate) oral solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Jazz Pharmaceuticals, Inc

Locations

Brain and Sleep Diagnostic Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

OMC-SXB-27

Identifier Type: -

Identifier Source: org_study_id