Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.|
- Number of Subjects Reporting Adverse Events [ Time Frame: Treatment Period (38 weeks) ] [ Designated as safety issue: Yes ]Number of subjects reporting adverse events.
|Study Start Date:||December 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423605
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