Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Fibromyalgia Clinical Trial

Official title:

A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423605
• Other study ID #: 06-010
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2007
• Last updated: March 28, 2012
• Start date: December 2006
• Est. completion date: January 2010

Study information

• Verified date: March 2012
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

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 information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Xyrem®
flexible dosing

Locations

Country	Name	City	State
France	Rhumatologie	Amiens Cedex 1
France	CHU de Grenoble-Hopital Sud	Echirolles Cedex
France	Hopital Claude Huriez Service de medecine interne	Lille Cedex
France	Centre Catherine de Sienne unite d evaluation et de traitement de la douleur	Nantes cedex 2
France	Hopital Hotel Dieu service de medicine interne	Paris cedex 04
France	CHU Hopital de Rangueil	Toulouse Cedex 9
Germany	Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie	Boblingen
Germany	Praxis Dr. Wiedeking	Essen
Germany	Praxis fur Innere Medizin und Rheumatologie	Grafelfing
Germany	Gemeinschaftspraxis Schmerzzentrum	Hamburg
Germany	Intensivmedizin der Uniklinik Koln	Koln
Germany	Praxisklinik Dr. Weiss	Mannheim
Germany	Praxis Dr. Sohn	Schwalmtal
Italy	Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara	Pisa
Netherlands	Amphia Ziekenhuis	Breda
Spain	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	Malaga
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela
United Kingdom	Lever Chambers Centre for Health	Bolton
United Kingdom	Kings College London	London
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United States	Upstate Clinical Research, LLC	Albany	New York
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Orange County Clinical Trials	Anaheim	California
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Suncoast Internal Medicine Consultants	Auburn	Alabama
United States	Walter F. Chase, MD PA	Austin	Texas
United States	Louisiana Sleep Foundation	Baton Rouge	Louisiana
United States	Tri State Medical Group, Inc.	Beaver	Pennsylvania
United States	Professional Clinical Research, Inc. at Crystal Lake Health Center	Benzonia	Michigan
United States	Appalachian Regional Medical Associates	Boone	North Carolina
United States	Graves - Gilbert Clinic	Bowling Green	Kentucky
United States	Professional Clinical Research	Cadillac	Michigan
United States	Northern California Research	Carmichael	California
United States	Charleston Internal Medicine	Charleston	West Virginia
United States	Low Country Research Country	Charleston	South Carolina
United States	Carolina Bone and Joint	Charlotte	North Carolina
United States	School of Osteopathic Medicine	Cherry Hill	New Jersey
United States	Fibromyalgia Treatment Centers of America	Chicago	Illinois
United States	Hill Top Physicians Inc./Hightop Medical Research Center	Cincinnati	Ohio
United States	Coeur d' Alene Arthritis Clinic	Coeur d' Alene	Idaho
United States	Southern Orthopaedic Sports Medicine	Columbia	South Carolina
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Anderson & Collins Clinical Research, Inc.	Edison	New Jersey
United States	Center for Arthiritis & Osteoporosis	Elizabethtown	Kentucky
United States	PRO Research	Eugene	Oregon
United States	Med Investigations Inc.	Fair Oaks	California
United States	Radiant Research, Greer	Greer	South Carolina
United States	Deerpath Physcians Group	Gurnee	Illinois
United States	R/D Clinical Research, Inc.	Houston	Texas
United States	Professional Clinical Research at Crystal Lake Health Center	Interlocken	Michigan
United States	Nerve Pro Research	Irvine	California
United States	Evergreen Hospital Medical Center	Kirkland	Washington
United States	Rheumatology Consultants, PLLC	Knoxville	Tennessee
United States	PCM Medical Services	Lansing	Michigan
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Commonwealth Biomedical Research, LLC	Madisonville	Kentucky
United States	Drug Studies America	Marietta	Georgia
United States	Central Pennsylvania Clinical Research	Mechanicsburg	Pennsylvania
United States	AppleMed Research	Miami	Florida
United States	Radiant Research	Mogadore	Ohio
United States	Compass Research	Orlando	Florida
United States	Balanced Health Research Center	Peoria	Illinois
United States	Arizona Research Center	Phoenix	Arizona
United States	Arroyo Medical Group, Inc.	Pismo Beach	California
United States	Sunrise Medical Research	Plantation	Florida
United States	School of Nursing	Portland	Oregon
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Pacific Rheumatology Associates, Inc.	Renton	Washington
United States	AAIR Research Center	Rochester	New York
United States	Capital Clinical Rsearch Asociates	Rockville	Maryland
United States	Fatigue Consultation Center	Salt Lake City	Utah
United States	Radiant Research San Antonio Northeast	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	The University of Texas Health Science	San Antonio	Texas
United States	Clinvest	Springfield	Missouri
United States	FutureCare Studies	Springfield	Massachusetts
United States	Clinical Research Group of St. Petersburg, Inc	St. Petersburg	Florida
United States	Tampa Medical Group, P.A.	Tampa	Florida
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma
United States	North Shore University Hospital	Valley Stream	New York
United States	Center for Arthiritis and Rheumatism	Vero Beach	Florida
United States	Omega Medical Research	Warwick	Rhode Island
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts
United States	Florida Medical Clinic, P.A.	Zephyhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting Adverse Events	Number of subjects reporting adverse events.	Treatment Period (38 weeks)	Yes