drugset / Trial / NCT00423605
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Timeline
- Start
- 2006-12
- Primary completion
- 2010-01
- Completion
- 2010-01
Publications
- Results 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.
- Spaeth 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Oxybate | Unknown | 4.5 g | — |
| Subject | Sodium Oxybate | Unknown | 9 g | — |