Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
NCT00423605 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 560
Last updated 2012-03-30
Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Conditions
- Fibromyalgia
Interventions
- DRUG
-
Xyrem®
flexible dosing
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2010-01-31
- Completion
- 2010-01-31
Countries
- United States
- France
- Germany
- Italy
- Netherlands
- Spain
- United Kingdom
Study Locations
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