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

NCT00087555 | Completed Phase 2 Results

• 1 other identifier: OMC-SXB-26
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 20

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Pain

Outcome Measures

Primary Outcomes (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).

  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"

  Baseline to week 8

Study Arms (3)

2

EXPERIMENTAL

Sodium oxybate 6.0 g per day.

Drug: Xyrem (sodium oxybate) oral solution

3

PLACEBO COMPARATOR

Placebo (one of two doses matching active treatment by volume).

Drug: Placebo

1

EXPERIMENTAL

Sodium oxybate 4.5 g per day.

Drug: Xyrem (sodium oxybate) oral solution

Interventions

Xyrem (sodium oxybate) oral solution DRUG

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.

1

Placebo DRUG

Placebo one of two doses matching active treatment by volume for 8 weeks.

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (20)

Radiant Research

Scottsdale, Arizona, 85251, United States

Location

Osteoporosis Medical Center

Beverly Hills, California, 90211, United States

Location

Wallace Rheumatic Study Center

Los Angeles, California, 90048, United States

Location

Miami Research Associates

Miami, Florida, 33173, United States

Location

Radiant Research, Inc.

West Palm Beach, Florida, 33407, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

LSU Health Sciences Center

Shreveport, Louisiana, 71130-3932, United States

Location

Richard N. Podell, MD

Springfield, New Jersey, 07081, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Alvin Daughtridge Arthritis Center

Lenoir, North Carolina, 28645, United States

Location

C.A.R.E. Center

Raleigh, North Carolina, 27609, United States

Location

Cleveland Sleep Center

Middlebrook Heights, Ohio, 44130, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Abigail Rebecca Neiman, MD

Katy, Texas, 77450, United States

Location

The University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Stress Medicine Clinic -- HealthSouth Rehabilitation Hospital

Sandy City, Utah, 84094, United States

Location

Pacific Rheumatology Research, Inc.

Renton, Washington, 98055, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98104, United States

Location

Related Publications (6)

• A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.

  PMID: 11833860 BACKGROUND

• A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.

  PMID: 12627729 BACKGROUND

• U.S. Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med. 2004 Mar;5(2):119-23. doi: 10.1016/j.sleep.2003.11.002.

  PMID: 15033130 BACKGROUND

• The abrupt cessation of therapeutically administered sodium oxybate (GHB) does not cause withdrawal symptoms. J Toxicol Clin Toxicol. 2003;41(2):131-5. doi: 10.1081/clt-120019128.

  PMID: 12733850 BACKGROUND

• Scharf MB, Baumann M, Berkowitz DV. The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia. J Rheumatol. 2003 May;30(5):1070-4.

  PMID: 12734908 BACKGROUND

• Russell IJ, Perkins AT, Michalek JE; Oxybate SXB-26 Fibromyalgia Syndrome Study Group. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2009 Jan;60(1):299-309. doi: 10.1002/art.24142.

  PMID: 19116896 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Sodium Oxybate; Solutions

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Pharmaceutical Preparations

Results Point of Contact

• Title: Grace Wang, MD Director of Clinical Development & Medical Monitor
• Organization: Jazz Pharmaceuticals, Inc.

650-496-3777

Study Officials

• Yanping Zheng, MD

  Jazz Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 12, 2004
• First Posted: July 14, 2004
• Study Start: July 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: January 1, 2006
• Last Updated: January 24, 2012
• Results First Posted: January 10, 2012

Record last verified: 2012-01

Locations

US (20)