Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
- Registration Number
- NCT00423605
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
- Detailed Description
The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 560
- Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
- Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.
- Subject terminated early from either study 06-009 or 06-008.
- Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
- Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Xyrem® -
- Primary Outcome Measures
Name Time Method Number of Subjects Reporting Adverse Events Treatment Period (38 weeks) Number of subjects reporting adverse events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (91)
Fibromyalgia Treatment Centers of America
🇺🇸Chicago, Illinois, United States
Center for Arthiritis and Rheumatism
🇺🇸Vero Beach, Florida, United States
Graves - Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
PCM Medical Services
🇺🇸Lansing, Michigan, United States
Praxisklinik Dr. Weiss
🇩🇪Mannheim, Germany
CHU de Grenoble-Hopital Sud
🇫🇷Echirolles Cedex, France
Hopital Claude Huriez Service de medecine interne
🇫🇷Lille Cedex, France
Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie
🇩🇪Boblingen, Germany
Intensivmedizin der Uniklinik Koln
🇩🇪Koln, Germany
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Instituto Ferran de Reumatologia
🇪🇸Barcelona, Spain
PRO Research
🇺🇸Eugene, Oregon, United States
Nerve Pro Research
🇺🇸Irvine, California, United States
Rheumatology Consultants, PLLC
🇺🇸Knoxville, Tennessee, United States
Northern California Research
🇺🇸Carmichael, California, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Deerpath Physcians Group
🇺🇸Gurnee, Illinois, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Tri State Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
Anderson & Collins Clinical Research, Inc.
🇺🇸Edison, New Jersey, United States
Hopital Hotel Dieu service de medicine interne
🇫🇷Paris cedex 04, France
CHU Hopital de Rangueil
🇫🇷Toulouse Cedex 9, France
Upstate Clinical Research, LLC
🇺🇸Albany, New York, United States
Tulsa Clinical Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Pacific Rheumatology Associates, Inc.
🇺🇸Renton, Washington, United States
Praxis Dr. Wiedeking
🇩🇪Essen, Germany
Evergreen Hospital Medical Center
🇺🇸Kirkland, Washington, United States
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Rhumatologie
🇫🇷Amiens Cedex 1, France
Centre Catherine de Sienne unite d evaluation et de traitement de la douleur
🇫🇷Nantes cedex 2, France
Gemeinschaftspraxis Schmerzzentrum
🇩🇪Hamburg, Germany
Fatigue Consultation Center
🇺🇸Salt Lake City, Utah, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
AppleMed Research
🇺🇸Miami, Florida, United States
Tampa Medical Group, P.A.
🇺🇸Tampa, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
School of Nursing
🇺🇸Portland, Oregon, United States
Radiant Research San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Arroyo Medical Group, Inc.
🇺🇸Pismo Beach, California, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Appalachian Regional Medical Associates
🇺🇸Boone, North Carolina, United States
Central Pennsylvania Clinical Research
🇺🇸Mechanicsburg, Pennsylvania, United States
The University of Texas Health Science
🇺🇸San Antonio, Texas, United States
Balanced Health Research Center
🇺🇸Peoria, Illinois, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
R/D Clinical Research, Inc.
🇺🇸Houston, Texas, United States
Hospital Santa Creu i Snt Pau
🇪🇸Barcelona, Spain
Hospital Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Suncoast Internal Medicine Consultants
🇺🇸Auburn, Alabama, United States
Orange County Clinical Trials
🇺🇸Anaheim, California, United States
Med Investigations Inc.
🇺🇸Fair Oaks, California, United States
Florida Medical Clinic, P.A.
🇺🇸Zephyhills, Florida, United States
Clinical Research Group of St. Petersburg, Inc
🇺🇸St. Petersburg, Florida, United States
Sunrise Medical Research
🇺🇸Plantation, Florida, United States
Center for Arthiritis & Osteoporosis
🇺🇸Elizabethtown, Kentucky, United States
Commonwealth Biomedical Research, LLC
🇺🇸Madisonville, Kentucky, United States
Professional Clinical Research at Crystal Lake Health Center
🇺🇸Interlocken, Michigan, United States
Clinvest
🇺🇸Springfield, Missouri, United States
School of Osteopathic Medicine
🇺🇸Cherry Hill, New Jersey, United States
Carolina Bone and Joint
🇺🇸Charlotte, North Carolina, United States
Hill Top Physicians Inc./Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
Radiant Research, Greer
🇺🇸Greer, South Carolina, United States
Praxis fur Innere Medizin und Rheumatologie
🇩🇪Grafelfing, Germany
Praxis Dr. Sohn
🇩🇪Schwalmtal, Germany
Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara
🇮🇹Pisa, Italy
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Civil de Malaga
🇪🇸Malaga, Spain
Lever Chambers Centre for Health
🇬🇧Bolton, United Kingdom
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Kings College London
🇬🇧London, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Compass Research
🇺🇸Orlando, Florida, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Low Country Research Country
🇺🇸Charleston, South Carolina, United States
Walter F. Chase, MD PA
🇺🇸Austin, Texas, United States
Professional Clinical Research, Inc. at Crystal Lake Health Center
🇺🇸Benzonia, Michigan, United States
Capital Clinical Rsearch Asociates
🇺🇸Rockville, Maryland, United States
FutureCare Studies
🇺🇸Springfield, Massachusetts, United States
Louisiana Sleep Foundation
🇺🇸Baton Rouge, Louisiana, United States
Coeur d' Alene Arthritis Clinic
🇺🇸Coeur d' Alene, Idaho, United States
Charleston Internal Medicine
🇺🇸Charleston, West Virginia, United States
Professional Clinical Research
🇺🇸Cadillac, Michigan, United States
North Shore University Hospital
🇺🇸Valley Stream, New York, United States
Southern Orthopaedic Sports Medicine
🇺🇸Columbia, South Carolina, United States
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
Radiant Research
🇺🇸Mogadore, Ohio, United States