A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
Launched by JAZZ PHARMACEUTICALS · Jan 17, 2007
Trial Information
Current as of May 27, 2025
Completed
Keywords
ClinConnect Summary
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-two (22) 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 a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be ...
Gender
ALL
Eligibility 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.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to identifying, developing, and commercializing innovative therapies that address unmet medical needs in various therapeutic areas, including sleep disorders, neurology, and hematology. With a strong commitment to advancing patient care, Jazz Pharmaceuticals leverages cutting-edge research and development to deliver transformative medicines that improve the quality of life for patients. The company emphasizes collaboration and integrity in its clinical trials, striving to ensure robust scientific rigor and ethical standards throughout its research endeavors. Through its innovative approaches and patient-centric focus, Jazz Pharmaceuticals aims to make a meaningful impact in the lives of those it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Antonio, Texas, United States
Duncansville, Pennsylvania, United States
Coeur D'alene, Idaho, United States
Northridge, California, United States
Elizabethtown, Kentucky, United States
St. Petersburg, Florida, United States
Cadillac, Michigan, United States
Tavares, Florida, United States
San Antonio, Texas, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Westfield, New York, United States
Houston, Texas, United States
Montgomery, Alabama, United States
Burbank, California, United States
Berlin, New Jersey, United States
Rockville, Maryland, United States
Indianapolis, Indiana, United States
Barcelona, , Spain
Breda, , Netherlands
Bingham Farms, Michigan, United States
Birmingham, Alabama, United States
Elblag, , Poland
Newcastle Upon Tyne, , United Kingdom
Santiago De Compostela, , Spain
Portland, Oregon, United States
Sacramento, California, United States
Barcelona, , Spain
San Antonio, Texas, United States
Milano, , Italy
Marietta, Georgia, United States
Fair Oaks, California, United States
Pismo Beach, California, United States
Orlando, Florida, United States
St. Louis, Missouri, United States
Omaha, Nebraska, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Anaheim, California, United States
Oviedo, , Spain
Sacramento, California, United States
Jacksonville, Florida, United States
Irvine, California, United States
Miami, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Baton Rouge, Louisiana, United States
Boone, North Carolina, United States
Beaver, Pennsylvania, United States
Columbia, South Carolina, United States
Houston, Texas, United States
Amiens Cedex 1, , France
Echirolles Cedex, , France
Lille Cedex, , France
Toulouse Cedex 9, , France
Boblingen, , Germany
Essen, , Germany
Grafelfing, , Germany
Hamburg, , Germany
Koln, , Germany
Mannheim, , Germany
Schwalmtal, , Germany
Pisa, , Italy
Barcelona, , Spain
Guadalajara, , Spain
Malaga, , Spain
Bolton, , United Kingdom
Auburn, Alabama, United States
Phoenix, Arizona, United States
Fullerton, California, United States
Farmington, Connecticut, United States
Gainesville, Florida, United States
Largo, Florida, United States
Vero Beach, Florida, United States
Zephyrhills, Florida, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Owensboro, Kentucky, United States
Benzonia, Michigan, United States
Interlochen, Michigan, United States
Hattiesburg, Mississippi, United States
St. Louis, Missouri, United States
East Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Valley Stream, New York, United States
Greenville, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Middleburg Heights, Ohio, United States
Portland, Oregon, United States
Yardley, Pennsylvania, United States
Austin, Texas, United States
Sugarland, Texas, United States
Waco, Texas, United States
Arlington, Virginia, United States
Nantes Cedex 2, , France
Nice Cedex 1, , France
Paris Cedex 04, , France
Berlin, , Germany
Hohenfelde Bad Doberan, , Germany
Enschede, , Netherlands
Katowice, , Poland
Poznan, , Poland
Szczecinie, , Poland
Torun, , Poland
Warszawa, , Poland
La Laguna, , Spain
Las Palmas De Gran Canaria, , Spain
Barnsley, , United Kingdom
Bath, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Newcastle, , United Kingdom
Poole, , United Kingdom
Poole, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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