Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
This study has been completed.
Information provided by (Responsible Party):
First received: January 16, 2007
Last updated: March 28, 2012
Last verified: March 2012
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2010 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423605
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.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 16, 2007
|Results First Received:
||September 12, 2011
||March 28, 2012
||United States: Food and Drug Administration
Keywords provided by Jazz Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Myofascial Pain Syndromes
Nervous System Diseases
Central Nervous System Agents
Central Nervous System Depressants
Physiological Effects of Drugs