Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
1 other identifier
interventional
560
7 countries
91
Brief Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2006
Typical duration for phase_3
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 16, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
October 20, 2011
CompletedMarch 30, 2012
March 1, 2012
3.1 years
January 16, 2007
September 12, 2011
March 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Reporting Adverse Events
Number of subjects reporting adverse events.
Treatment Period (38 weeks)
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Suncoast Internal Medicine Consultants
Auburn, Alabama, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Orange County Clinical Trials
Anaheim, California, United States
Northern California Research
Carmichael, California, 95608, United States
Med Investigations Inc.
Fair Oaks, California, United States
Nerve Pro Research
Irvine, California, United States
Arroyo Medical Group, Inc.
Pismo Beach, California, 93449, United States
AppleMed Research
Miami, Florida, United States
Compass Research
Orlando, Florida, 32806, United States
Sunrise Medical Research
Plantation, Florida, 33317, United States
Clinical Research Group of St. Petersburg, Inc
St. Petersburg, Florida, United States
Tampa Medical Group, P.A.
Tampa, Florida, United States
Center for Arthiritis and Rheumatism
Vero Beach, Florida, United States
Florida Medical Clinic, P.A.
Zephyhills, Florida, United States
Drug Studies America
Marietta, Georgia, United States
Coeur d' Alene Arthritis Clinic
Coeur d'Alene, Idaho, United States
Fibromyalgia Treatment Centers of America
Chicago, Illinois, United States
Deerpath Physcians Group
Gurnee, Illinois, 60031, United States
Balanced Health Research Center
Peoria, Illinois, 61614, United States
Graves - Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Center for Arthiritis & Osteoporosis
Elizabethtown, Kentucky, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431, United States
Louisiana Sleep Foundation
Baton Rouge, Louisiana, United States
Capital Clinical Rsearch Asociates
Rockville, Maryland, United States
FutureCare Studies
Springfield, Massachusetts, 01103, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Professional Clinical Research, Inc. at Crystal Lake Health Center
Benzonia, Michigan, United States
Professional Clinical Research
Cadillac, Michigan, United States
Professional Clinical Research at Crystal Lake Health Center
Interlocken, Michigan, 49643, United States
PCM Medical Services
Lansing, Michigan, 48917, United States
Clinvest
Springfield, Missouri, 65807, United States
School of Osteopathic Medicine
Cherry Hill, New Jersey, 08002, United States
Anderson & Collins Clinical Research, Inc.
Edison, New Jersey, 08817, United States
Upstate Clinical Research, LLC
Albany, New York, 12205, United States
AAIR Research Center
Rochester, New York, 14618, United States
North Shore University Hospital
Valley Stream, New York, United States
Appalachian Regional Medical Associates
Boone, North Carolina, United States
Carolina Bone and Joint
Charlotte, North Carolina, 28210, United States
Duke University Medical Center
Durham, North Carolina, 27103, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Hill Top Physicians Inc./Hightop Medical Research Center
Cincinnati, Ohio, United States
Radiant Research
Mogadore, Ohio, 44260, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104, United States
PRO Research
Eugene, Oregon, 97401, United States
School of Nursing
Portland, Oregon, United States
Tri State Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Low Country Research Country
Charleston, South Carolina, 29406, United States
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, United States
Radiant Research, Greer
Greer, South Carolina, 29651, United States
Rheumatology Consultants, PLLC
Knoxville, Tennessee, 37909, United States
Walter F. Chase, MD PA
Austin, Texas, 78705, United States
R/D Clinical Research, Inc.
Houston, Texas, 77074, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, 78217, United States
The University of Texas Health Science
San Antonio, Texas, 78229, United States
Fatigue Consultation Center
Salt Lake City, Utah, 84102, United States
Evergreen Hospital Medical Center
Kirkland, Washington, 98034, United States
Pacific Rheumatology Associates, Inc.
Renton, Washington, 98055, United States
Charleston Internal Medicine
Charleston, West Virginia, 25304, United States
Rhumatologie
Amiens, France
CHU de Grenoble-Hopital Sud
Échirolles, France
Hopital Claude Huriez Service de medecine interne
Lille, France
Centre Catherine de Sienne unite d evaluation et de traitement de la douleur
Nantes, France
Hopital Hotel Dieu service de medicine interne
Paris, France
CHU Hopital de Rangueil
Toulouse, France
Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie
Böblingen, Germany
Intensivmedizin der Uniklinik Koln
Cologne, Germany
Praxis Dr. Wiedeking
Essen, Germany
Praxis fur Innere Medizin und Rheumatologie
Gräfelfing, Germany
Gemeinschaftspraxis Schmerzzentrum
Hamburg, Germany
Praxisklinik Dr. Weiss
Mannheim, Germany
Praxis Dr. Sohn
Schwalmtal, Germany
Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara
Pisa, Italy
Amphia Ziekenhuis
Breda, Netherlands
Hospital Santa Creu i Snt Pau
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Instituto Ferran de Reumatologia
Barcelona, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital Civil de Malaga
Málaga, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain
Lever Chambers Centre for Health
Bolton, United Kingdom
Kings College London
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Related Publications (2)
Spaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.
RESULTSpaeth M, Alegre C, Perrot S, Wang Y, Guinta DR, Alvarez-Horine S, Russell I; Sodium Oxybate Fibromyalgia Study Group. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia. Arthritis Res Ther. 2013 Nov 11;15(6):R185. doi: 10.1186/ar4375.
PMID: 24286114DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grace Wang, MD, Director Clinical Development & Medical Monitor
- Organization
- Jazz Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2007
First Posted
January 18, 2007
Study Start
December 1, 2006
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
March 30, 2012
Results First Posted
October 20, 2011
Record last verified: 2012-03