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

NCT ID: NCT00371137

Last Updated: 2011-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

548 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fibromyalgia

Keywords

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FMS Fibro pain Body pain tenderness joint pain stiffness muscular pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Solution

2

Group Type EXPERIMENTAL

Xyrem®

Intervention Type DRUG

two doses

Interventions

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Xyrem®

two doses

Intervention Type DRUG

Placebo

Oral Solution

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jazz Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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I. Jon Russell, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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Pinnacle Research Group, LLC

Anniston, Alabama, United States

Site Status

Rheumatology Associates of N. AL, PC

Huntsville, Alabama, United States

Site Status

Xenoscience, Inc. dba 21st Century Neurology

Phoenix, Arizona, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Advanced Clinical Research Institute

Anaheim, California, United States

Site Status

Providence Clinical Research

Burbank, California, United States

Site Status

Northern California Research

Carmichael, California, United States

Site Status

Pasadena Rehabilitation Institute

Pasadena, California, United States

Site Status

Arroyo Medical Group

Pismo Beach, California, United States

Site Status

Sacramento Research Medical Group

Sacramento, California, United States

Site Status

Apex Research Institute

Santa Ana, California, United States

Site Status

Sansum Clinic

Santa Barbara, California, United States

Site Status

Robert E. Harris, MD Medical Corporation

Whittier, California, United States

Site Status

CRIA Research

Fort Lauderdale, Florida, United States

Site Status

Clinical Physiology Associates Clinical Study Center

Fort Meyers, Florida, United States

Site Status

Innovative Research

Largo, Florida, United States

Site Status

Compass Research

Orlando, Florida, United States

Site Status

Sunrise Medical Research

Plantation, Florida, United States

Site Status

Coastal Medical Research, Inc

Port Orange, Florida, United States

Site Status

Deerpath Physicians Group

Gurnee, Illinois, United States

Site Status

Balanced health Research Center

Peoria, Illinois, United States

Site Status

Welborn Clinic

Evansville, Indiana, United States

Site Status

Investigative Clinical Research of Indiana, LLC

Indianapolis, Indiana, United States

Site Status

Graves - Gilbert Clinic

Bowling Green, Kentucky, United States

Site Status

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, United States

Site Status

Commonwealth Biomedical Reseach, LLC

Madisonville, Kentucky, United States

Site Status

FutureCare Studies

Springfield, Massachusetts, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

PCM Medical Services

Lansing, Michigan, United States

Site Status

Clinvest

Springfield, Missouri, United States

Site Status

Clayton Medical Associates

St Louis, Missouri, United States

Site Status

St. John's Mercy Health System

St Louis, Missouri, United States

Site Status

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Site Status

CCR Trials

Berlin, New Jersey, United States

Site Status

School of Osteopathic Medicine

Cherry Hill, New Jersey, United States

Site Status

Anderson & Collins Clinical Research, Inc.

Edison, New Jersey, United States

Site Status

Upstate Clinical Research, LLC

Albany, New York, United States

Site Status

AAIR Research Center

Rochester, New York, United States

Site Status

Great Lakes Medical Research

Westfield, New York, United States

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Carolina Bone and Joint

Charlotte, North Carolina, United States

Site Status

Carolinas Research

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Radiant Research

Columbus, Ohio, United States

Site Status

Signal Point Clinical Research Center, LLC

Middletown, Ohio, United States

Site Status

Radiant Research

Mogadore, Ohio, United States

Site Status

Clinical Research Source, Inc.

Perrysburg, Ohio, United States

Site Status

Health Research Institute

Oklahoma City, Oklahoma, United States

Site Status

Tulsa Clinical Research, LLC

Tulsa, Oklahoma, United States

Site Status

PRO Research

Eugene, Oregon, United States

Site Status

Medford Medical Clinic, LLP

Medford, Oregon, United States

Site Status

Central Pennsylvania Clinical Research

Mechanicsburg, Pennsylvania, United States

Site Status

Omega Medical Research

Warwick, Rhode Island, United States

Site Status

Low Country Research Center

Charleston, South Carolina, United States

Site Status

Radiant Research, Greer

Greer, South Carolina, United States

Site Status

Clinsearch

Chattanooga, Tennessee, United States

Site Status

Rheumatology Consultants, PLLC

Knoxville, Tennessee, United States

Site Status

Walter M. Chase, MD

Austin, Texas, United States

Site Status

Future Search Trials of Neurology Future Research Trials

Austin, Texas, United States

Site Status

DFW Wellness

Fort Worth, Texas, United States

Site Status

The Methodist Hospital Systems

Houston, Texas, United States

Site Status

Houston Sleep Center

Houston, Texas, United States

Site Status

Sun Research Institute

San Antonio, Texas, United States

Site Status

Radiant Research San Antonio Northeast

San Antonio, Texas, United States

Site Status

The University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

Fatigue Consultation Center

Salt Lake City, Utah, United States

Site Status

Richard A. Neiman, MD, Inc.

Kirkland, Washington, United States

Site Status

Pacific Rheumatolgy Associates, Inc.

Renton, Washington, United States

Site Status

Charrleston Internal Medicine

Charleston, West Virginia, United States

Site Status

Countries

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Canada United States

References

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Russell JI, Holman AJ, Swick TJ, Alvarez-Horine S, Wang GY, Guinta D; Sodium Oxybate 06-008 FM Study Group. Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: results from a 14-week, randomized, double-blind, placebo-controlled study. Pain. 2011 May;152(5):1007-1017. doi: 10.1016/j.pain.2010.12.022. Epub 2011 Mar 11.

Reference Type RESULT
PMID: 21397402 (View on PubMed)

Swick TJ, Alvarez-Horine S, Zheng Y, Rothman J, Inhaber N, Holman AJ, Smith TR, Russell IJ. Sodium Oxybate Improves Pain, Fatigue, and Sleep in Fibromyalgia: Results from a 14-Week Randomized, Double-Blind, Placebo-Controlled Trial. [APSS abstract 0984]. Sleep 2009;32(suppl):A321.

Reference Type RESULT

Swick TJ, Alvarez-Horine S, Zheng Y, Guinta D, Inhaber N, Holman AJ, Smith TR, Russell IJ. Impaired Sleep and Daytime Functioning at Baseline in Subjects with Fibromyalgia from a 14-Week Randomized, Double-Blind, Placebo-Controlled Trial of Sodium Oxybate. [APSS abstract 1013]. Sleep 2009;32(suppl):A330.

Reference Type RESULT

Mease PJ, Swick TJ, Alvarez-Horine S, Inhaber N, Guinta DR, Holman AJ, and Russell IJ. Sodium Oxybate Improves Fatigue, Sleep Disturbance, and PGIC in Fibromyalgia-Results form a Phase 3, 14-Week, Controlled Trial. Arthritis & Rheum 2009;60(10):S529.

Reference Type RESULT

Russell IJ, Alvarez-Horine S, Zheng Y, Guinta DR, Holman AJ and Swick TJ. Effect of Sodium Oxybate on Pain, PGIC, & Composite Scores in Fibromyalgia-Results from a Phase 3 Controlled Trial. Arthritis & Rheum 2009;60(10):S528.

Reference Type RESULT

Swick TJ, Rosenfeld V, Alvarez-Horine S, Guinta D, Wang YG, Russell IJ. Improvement in Multiple Symptoms of Fibromyalgia With Sodium Oxybate Treatment: Results From a US Phase 3 Randomized, Controlled Trial [AAN abstract P03.292]. Neurology. 2010;74(suppl 2):A279.

Reference Type RESULT

Jones KD, Bennett RM, Alvarez-Horine S, Wang YG, Guinta D, Russell IJ. Sodium Oxybate Improves Function and Quality of Life in Fibromyalgia-Results From a Phase 3, Randomized, Controlled Trial [APS abstract 262]. J Pain. 2010;11(suppl 1):S41.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 19116896 (View on PubMed)

Silverman S, Holman AJ, Benson B, Alvarez-Horine S, Wang YG, Sarzi-Puttini. Sodium Oxybate Improves Sleep and Fatigue in Patients With Fibromyalgia: Pooled Analysis From 2 Pivotal Clinical Trials [ACR/ARHP abstract 2337]. Arthritis Rheum. 2010;62(suppl 10):815.

Reference Type RESULT

Spaeth M, Russell IJ, Perrot S, Choy E, Benson B, Wang YG, Lai C. The Effects of Sodium Oxybate on Multiple Symptoms of Fibromyalgia: Results From Two Phase 3, Randomized, Double-Blind, Controlled Trials. In: Myopain 2010 Abstracts; October 3-7, 2010; Toledo, Spain. Abstract 39.

Reference Type RESULT

Other Identifiers

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06-008

Identifier Type: -

Identifier Source: org_study_id