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

Condition(s) targeted: Fibromyalgia

Intervention: Xyrem® (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Jazz Pharmaceuticals

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.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Pain Severity accessed by VAS

Fibromyalgia Impact Questionnaire

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Pinnacle Research Group, LLC, Anniston, Alabama 36207, United States

Rheumatology Associates of N. AL, PC, Huntsville, Alabama 35801, United States

Arizona Research Center, Phoenix, Arizona 85023, United States

Xenoscience, Inc. dba 21st Century Neurology, Phoenix, Arizona 85004, United States

Arroyo Medical Group, Pismo Beach, California 93449, United States

Advanced Clinical Research Institute, Anaheim, California 92801, United States

Apex Research Institute, Santa Ana, California 92705, United States

Northern California Research, Carmichael, California 95608, United States

Sacramento Research Medical Group, Sacramento, California 95825, United States

Pasadena Rehabilitation Institute, Pasadena, California 91105, United States

Robert E. Harris, MD Medical Corporation, Whittier, California 90601, United States

Providence Clinical Research, Burbank, California 91505, United States

Sansum Clinic, Santa Barbara, California 93110, United States

CRIA Research, Ft. Lauderdale, Florida 33334, United States

Sunrise Medical Research, Plantation, Florida 33317, United States

Compass Research, Orlando, Florida 32806, United States

Innovative Research, Largo, Florida 33770, United States

Coastal Medical Research, Inc, Port Orange, Florida 32127, United States

Clinical Physiology Associates Clinical Study Center, Fort Meyers, Florida 33916, United States

Deerpath Physicians Group, Gurnee, Illinois 60031, United States

Balanced health Research Center, Peoria, Illinois 61614, United States

Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana 46254, United States

Welborn Clinic, Evansville, Indiana 47713, United States

Central Kentucky Research Associates, Inc., Lexington, Kentucky 40509, United States

Commonwealth Biomedical Reseach, LLC, Madisonville, Kentucky 42431, United States

Graves - Gilbert Clinic, Bowling Green, Kentucky 42101, United States

FutureCare Studies, Springfield, Massachusetts 01103, United States

Clinical Pharmacology Study Group, Worcester, Massachusetts 01610, United States

PCM Medical Services, Lansing, Michigan 48917, United States

Clinvest, Springfield, Missouri 65807, United States

St. John's Mercy Health System, St. Louis, Missouri 63141, United States

Clayton Medical Associates, St. Louis, Missouri 63117, United States

Quality Clinical Research, Inc., Omaha, Nebraska 68114, United States

Anderson & Collins Clinical Research, Inc., Edison, New Jersey 08817, United States

School of Osteopathic Medicine, Cherry Hill, New Jersey 08002, United States

CCR Trials, Berlin, New Jersey 08009, United States

Upstate Clinical Research, LLC, Albany, New York 12205, United States

AAIR Research Center, Rochester, New York 14618, United States

Great Lakes Medical Research, Westfield, New York 14787, United States

The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States

Wake Research Associates, LLC, Raleigh, North Carolina 27612, United States

Duke University Medical Center, Durham, North Carolina 27705, United States

Carolina Bone and Joint, Charlotte, North Carolina 28210, United States

Carolinas Research, Charlotte, North Carolina 28226, United States

Radiant Research, Columbus, Ohio 43212, United States

Radiant Research, Mogadore, Ohio 44260, United States

Signal Point Clinical Research Center, LLC, Middletown, Ohio 45042, United States

Clinical Research Source, Inc., Perrysburg, Ohio 43551, United States

Tulsa Clinical Research, LLC, Tulsa, Oklahoma 74104, United States

Health Research Institute, Oklahoma City, Oklahoma 73109, United States

PRO Research, Eugene, Oregon 97401, United States

Medford Medical Clinic, LLP, Medford, Oregon 97504, United States

Central Pennsylvania Clinical Research, Mechanicsburg, Pennsylvania 17055, United States

Omega Medical Research, Warwick, Rhode Island 02886, United States

Low Country Research Center, Charleston, South Carolina 29406, United States

Radiant Research, Greer, Greer, South Carolina 29651, United States

Rheumatology Consultants, PLLC, Knoxville, Tennessee 37909, United States

Clinsearch, Chattanooga, Tennessee 37421, United States

Houston Sleep Center, Houston, Texas 77063, United States

Walter M. Chase, MD, Austin, Texas 78705, United States

Radiant Research San Antonio Northeast, San Antonio, Texas 78217, United States

The University of Texas Health Science Center, San Antonio, Texas 78229, United States

DFW Wellness, Fort Worth, Texas 76108, United States

Sun Research Institute, San Antonio, Texas 78205, United States

Future Search Trials of Neurology Future Research Trials, Austin, Texas 78756, United States

The Methodist Hospital Systems, Houston, Texas 77030, United States

Fatigue Consultation Center, Salt Lake City, Utah 84102, United States

Pacific Rheumatolgy Associates, Inc., Renton, Washington 98055, United States

Richard A. Neiman, MD, Inc., Kirkland, Washington 98034, United States

Charrleston Internal Medicine, Charleston, West Virginia 25304, United States

Starting date: August 2006
Ending date: November 2008
Last updated: June 4, 2008