Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jazz Pharmaceuticals
• Treatments: Sodium Oxybate

Criteria

Inclusion Criteria:

• Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).

• Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.

Exclusion Criteria:

• Subject terminated early from either study 06-009 or 06-008.

• Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.

• Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.