Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Xyrem (sodium oxybate) oral solution; Xyrem (sodium oxybate) oral solution; Placebo
Intervention description: 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.; 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 one of two doses matching active treatment by volume for 8 weeks.
Intervention MeSH terms: Sodium Oxybate; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fibromyalgia; Pain

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.
    

Eligibility criteria:

        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