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

Jazz Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Fibromyalgia

Treatments

Drug: Xyrem®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00423605

06-010

Details and patient eligibility

About

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

Full description

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.

Enrollment

560 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.