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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