Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Overview
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Full Title of Study: “A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 2010
Detailed Description
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.
Interventions
- Drug: Xyrem®
- flexible dosing
Arms, Groups and Cohorts
- Experimental: 1
Clinical Trial Outcome Measures
Primary Measures
- Number of Subjects Reporting Adverse Events
- Time Frame: Treatment Period (38 weeks)
- Number of subjects reporting adverse events.
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Jazz Pharmaceuticals
- Provider of Information About this Clinical Study
- Sponsor
Citations Reporting on Results
Spaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.
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