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Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00087555
Recruitment Status : Completed
First Posted : July 14, 2004
Results First Posted : January 10, 2012
Last Update Posted : January 24, 2012
Information provided by:
Jazz Pharmaceuticals

Brief Summary:
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Xyrem (sodium oxybate) oral solution Drug: Placebo Phase 2

Detailed Description:
Fibromyalgia affects millions of Americans, yet there are no FDA approved drugs to treat this debilitating condition. Besides causing pain, it also disrupts normal sleep patterns in many of its victims. Pain and lack of sleep reinforce each other, making patients progressively more miserable. Xyrem is a potent hypnotic that induces and consolidates sleep. In a few small studies Xyrem has been reported to offer relief to some fibromyalgia patients. This trial is designed to test this hypothesis. Patients who enroll in this study will stop taking any prescription medications for fibromyalgia (over-the-counter pain relievers will be permitted). They will then take either Xyrem alone or placebo alone. Patients will be followed for eight weeks to evaluate any relief of the pain or functional impairment of fibromyalgia from their study treatment. Sleep characteristics will also be assessed subjectively and by polysomnographic recordings at baseline and twice during the treatment phase.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem(R) (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
Study Start Date : July 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 2
Sodium oxybate 6.0 g per day.
Drug: Xyrem (sodium oxybate) oral solution
Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks.

Placebo Comparator: 3
Placebo (one of two doses matching active treatment by volume).
Drug: Placebo
Placebo one of two doses matching active treatment by volume for 8 weeks.

Experimental: 1
Sodium oxybate 4.5 g per day.
Drug: Xyrem (sodium oxybate) oral solution
Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks.

Primary Outcome Measures :
  1. The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C). [ Time Frame: Baseline to week 8 ]

    The percentage of participants who met all 3 of the following criteria:

    Reduction of >=20% from baseline to week 8 in both PVAS & FIQ total score and PGI-C response of "very much better" or "much better". Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from "very much worse" to "very much better"

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Sign & date informed consent
  • Willing & able to complete trial as described in protocol
  • > 18 years of age
  • Meet American College of Rheumatology criteria for Fibromyalgia [Widespread pain for at least 3 months, including all of the following: (1) Pain on right & left sides of body; (2) Pain above & below waist; (3) Pain in axial skeleton; 4) Pain on digital palpation with approximately 4kg force in at least 11 of 18 tender point sites]
  • (Study continuation) Have an average VAS pain score > 4 on a scale of 0 to 10 as recorded in patient diary the last week before Visit 4.
  • Discontinue all prescription medication taken for fibromyalgia, including opiates, benzodiazepines, anticonvulsants taken for pain, antidepressants, cyclobenzaprine (Flexeril), and/or tramadol (Ultram) until study completion
  • Continue all pre-existing nutritional and/or exercise regimens and/or behavioral, massage, acupuncture, physical or cognitive therapies on an unchanged, consistent & regular schedule throughout study
  • Use only acetaminophen or over-the-counter non-steroidal anti-inflammatory drugs as rescue pain medications & to limit dose to the labeled over-the-counter maximum. Aspirin may only be used as a cardiac protectant; formulations with caffeine are excluded.
  • Forego ingestion of alcohol for duration of study.
  • Fertile females must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) for duration of trial.

Exclusion Criteria

  1. Have any of the following medical conditions:

    • Other rheumatic disease, such as rheumatoid arthritis, osteoarthritis, or systemic lupus erythematosis
    • Uncontrolled hypo- or hyper-thyroidism of any type
    • Unstable cardiovascular, endocrine, neoplastic (excluding localized basal cell carcinoma), gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place patient at risk during trial or compromise objectives outlined in protocol
    • Myocardial infarction within last six months
    • On their screening PSG (polysomnogram) have an Apnea Index greater than 10 per hour or an Apnea Hypopnea Index greater than 15 per hour. Note: patients with sleep apnea are not excluded if their indices are below these thresholds while sleeping with CPAP (Continuous Positive Airway Pressure) and they are compliant with CPAP therapy.
    • Problems that, in the investigator's opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms.
    • If a patient will have to discontinue antidepressant medication taken for depression, the investigator must make an evaluation as to any risks from cessation of anti-depressant therapy. If, in the opinion of the investigator, a reasonable risk of resultant patient harm exists, patient is excluded from study participation
    • Current or recent history of substance abuse including alcohol abuse
    • History of seizure disorder, history of head trauma, migraine headaches or intracranial surgery, & are taking anticonvulsants
    • Succinic semialdehyde dehydrogenase deficiency
  2. Have taken any of these therapies:

    • gamma-hydroxybutyrate (sodium oxybate) in 30 days prior to signing informed consent
    • any investigational therapy in 30 days prior to signing informed consent
    • ever taken anticonvulsants to treat epilepsy or any other convulsions
  3. Unwilling to stop these therapies during course of trial:

    • anticonvulsants prescribed solely for pain
    • all antidepressants
    • medication for sleep
  4. Have any of the following clinical laboratory results:

    • Serum creatinine > 2.0 mg/dL
    • TSH (Thyroid Stimulating Hormone) < 0.3 μU/mL OR TSH > 6 μU/mL
    • abnormal liver function tests (SGOT [AST] or SGPT [ALT] more than twice the upper limit of normal)
    • elevated serum bilirubin (more than 1.5 times the upper limit of normal)
    • pre-trial ECG with arrhythmia, greater than a first degree AV block
    • positive pregnancy test at any time during trial
  5. Have any of the following socio-economic factors:

    • Pending worker's compensation litigation or related other monetary settlements
    • Have an occupation that requires variable shift work or routine night shifts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00087555

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Sponsors and Collaborators
Jazz Pharmaceuticals
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Study Director: Yanping Zheng, MD Jazz Pharmaceuticals, Inc
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Responsible Party: Senior Director Clinical Development, Jazz Pharmaceuticals, Inc. Identifier: NCT00087555    
Other Study ID Numbers: OMC-SXB-26
First Posted: July 14, 2004    Key Record Dates
Results First Posted: January 10, 2012
Last Update Posted: January 24, 2012
Last Verified: January 2012
Keywords provided by Jazz Pharmaceuticals:
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sodium Oxybate
Pharmaceutical Solutions
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs