A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia


Brief Summary

The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

Intervention / Treatment

  • Xyrem® (DRUG)
    two doses
  • Placebo (DRUG)
    Oral Solution

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: 548 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Treatment


    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2006
    Primary Completion: Sep 01, 2008 ACTUAL
    Completion Date: Dec 01, 2008 ACTUAL
    Study First Posted: Sep 01, 2006 ESTIMATED
    Results First Posted: Nov 30, 2011 ESTIMATED
    Last Updated: Dec 21, 2011

    Sponsors / Collaborators

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


    The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-one (21) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined, followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

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

    Inclusion Criteria:

    * Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.

    Exclusion Criteria:

    * Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms.
    * Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.

    Primary Outcomes
    • Percentage of pain VAS responders. Subjects with a \>= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.

    More Details

    NCT Number: NCT00371137
    Other IDs: 06-008
    Study URL: https://clinicaltrials.gov/study/NCT00371137
    Last updated: Sep 29, 2023