Phase 3
Completed N=560
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Source: ClinicalTrials.gov NCT00423605 ↗Enrolled (actual)
560
Serious AEs
3.4%
Results posted
Oct 2011
Primary outcomePrimary: Number of Subjects Reporting Adverse Events — 498 Participants
Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Adverse Events |
498 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00423605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.