Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Jazz Pharmaceuticals560 enrolled

Overview

The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

560

Conditions

Fibromyalgia

Interventions

Xyrem®DRUG

flexible dosing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (91)

Outcomes

Primary Outcomes

Number of Subjects Reporting Adverse Events

Number of subjects reporting adverse events.

Time frame: Treatment Period (38 weeks)

Data from ClinicalTrials.gov

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