Phase 3
Completed N=548
A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Source: ClinicalTrials.gov NCT00371137 ↗Enrolled (actual)
548
Serious AEs
0.5%
Results posted
Nov 2011
Primary outcomePrimary: Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). — 27.3; 46.2; 39.3; 72.7 Percentage of Participants — p=>0.001
Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). |
27.3; 46.2; 39.3; 72.7; 53.8; 60.7 | >0.001 |
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.
Data sourced from ClinicalTrials.gov (NCT00371137). 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.