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

Narcolepsy Clinical Trial

Official title:

Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132873
• Other study ID #: OMC-SXB-27
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2005
• Last updated: September 18, 2013
• Start date: October 2004
• Est. completion date: December 2007

Study information

• Verified date: September 2013
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial

• Signed and dated an informed consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Narcolepsy

Intervention

Drug:
• Xyrem (sodium oxybate) oral solution
Xyrem (sodium oxybate) oral solution

Locations

Country	Name	City	State
Canada	Brain and Sleep Diagnostic Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Experiences	Number of Subjects with treatment-emergent adverse events.	continuous	Yes
Primary	Vital Signs	Average Respiratory Rate at 1 year.	At 1 year	Yes