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

Completed · Phase 2 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID: NCT00087555
Run by: Jazz Pharmaceuticals
People needed: 195
Starts: 2004-07-01
Expected to finish: 2006-01-01
Last updated by the study team: 2012-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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
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
Unwilling to stop these therapies during course of trial:
anticonvulsants prescribed solely for pain
all antidepressants
medication for sleep
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

Where it is running

Radiant Research — Scottsdale, Arizona, United States
Osteoporosis Medical Center — Beverly Hills, California, United States
Wallace Rheumatic Study Center — Los Angeles, California, United States
Miami Research Associates — Miami, Florida, United States
Radiant Research, Inc. — West Palm Beach, Florida, United States
Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
LSU Health Sciences Center — Shreveport, Louisiana, United States
Richard N. Podell, MD — Springfield, New Jersey, United States
Duke University Medical Center — Durham, North Carolina, United States
Alvin Daughtridge Arthritis Center — Lenoir, North Carolina, United States
C.A.R.E. Center — Raleigh, North Carolina, United States
Cleveland Sleep Center — Middlebrook Heights, Ohio, United States
Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
Oregon Health and Science University — Portland, Oregon, United States
Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
Abigail Rebecca Neiman, MD — Katy, Texas, United States
The University of Texas Health Science Center — San Antonio, Texas, United States
Stress Medicine Clinic -- HealthSouth Rehabilitation Hospital — Sandy City, Utah, United States
Pacific Rheumatology Research, Inc. — Renton, Washington, United States
Seattle Rheumatology Associates — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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