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


Brief Summary

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

Intervention / Treatment

  • Xyrem® (DRUG)
    flexible dosing

Condition or Disease

  • Fibromyalgia


  • Phase 3
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 560 (ACTUAL)
    Funded by: Industry
    Allocation: Non-Randomized
    Primary Purpose: Treatment


    Clinical Trial Dates

    Start date: Dec 01, 2006
    Primary Completion: Jan 01, 2010 ACTUAL
    Completion Date: Jan 01, 2010 ACTUAL
    Study First Posted: Jan 18, 2007 ESTIMATED
    Results First Posted: Oct 20, 2011 ESTIMATED
    Last Updated: Mar 28, 2012

    Sponsors / Collaborators

    Lead Sponsor: Jazz Pharmaceuticals
    Lead sponsor is responsible party
    Responsible Party: N/A


    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.

    Participant Groups

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • Number of subjects reporting adverse events.

    More Details

    NCT Number: NCT00423605
    Other IDs: 06-010
    Study URL:
    Last updated: Sep 29, 2023