Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes 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.
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):