A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

This study has been completed.
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: August 30, 2006
Last updated: December 21, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Drug: Xyrem®
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

Resource links provided by NLM:

Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
    Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.

Enrollment: 548
Study Start Date: August 2006
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Oral Solution
Experimental: 2 Drug: Xyrem®
two doses

Detailed Description:
The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-one (21) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined, followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371137

  Show 70 Study Locations
Sponsors and Collaborators
Jazz Pharmaceuticals
Principal Investigator: I. Jon Russell, PhD, MD The University of Texas Health Science Center at San Antonio
  More Information

Swick TJ, Alvarez-Horine S, Zheng Y, Rothman J, Inhaber N, Holman AJ, Smith TR, Russell IJ. Sodium Oxybate Improves Pain, Fatigue, and Sleep in Fibromyalgia: Results from a 14-Week Randomized, Double-Blind, Placebo-Controlled Trial. [APSS abstract 0984]. Sleep 2009;32(suppl):A321.
Swick TJ, Alvarez-Horine S, Zheng Y, Guinta D, Inhaber N, Holman AJ, Smith TR, Russell IJ. Impaired Sleep and Daytime Functioning at Baseline in Subjects with Fibromyalgia from a 14-Week Randomized, Double-Blind, Placebo-Controlled Trial of Sodium Oxybate. [APSS abstract 1013]. Sleep 2009;32(suppl):A330.
Mease PJ, Swick TJ, Alvarez-Horine S, Inhaber N, Guinta DR, Holman AJ, and Russell IJ. Sodium Oxybate Improves Fatigue, Sleep Disturbance, and PGIC in Fibromyalgia-Results form a Phase 3, 14-Week, Controlled Trial. Arthritis & Rheum 2009;60(10):S529.
Russell IJ, Alvarez-Horine S, Zheng Y, Guinta DR, Holman AJ and Swick TJ. Effect of Sodium Oxybate on Pain, PGIC, & Composite Scores in Fibromyalgia-Results from a Phase 3 Controlled Trial. Arthritis & Rheum 2009;60(10):S528.
Swick TJ, Rosenfeld V, Alvarez-Horine S, Guinta D, Wang YG, Russell IJ. Improvement in Multiple Symptoms of Fibromyalgia With Sodium Oxybate Treatment: Results From a US Phase 3 Randomized, Controlled Trial [AAN abstract P03.292]. Neurology. 2010;74(suppl 2):A279.
Jones KD, Bennett RM, Alvarez-Horine S, Wang YG, Guinta D, Russell IJ. Sodium Oxybate Improves Function and Quality of Life in Fibromyalgia—Results From a Phase 3, Randomized, Controlled Trial [APS abstract 262]. J Pain. 2010;11(suppl 1):S41.
Silverman S, Holman AJ, Benson B, Alvarez-Horine S, Wang YG, Sarzi-Puttini. Sodium Oxybate Improves Sleep and Fatigue in Patients With Fibromyalgia: Pooled Analysis From 2 Pivotal Clinical Trials [ACR/ARHP abstract 2337]. Arthritis Rheum. 2010;62(suppl 10):815.
Spaeth M, Russell IJ, Perrot S, Choy E, Benson B, Wang YG, Lai C. The Effects of Sodium Oxybate on Multiple Symptoms of Fibromyalgia: Results From Two Phase 3, Randomized, Double-Blind, Controlled Trials. In: Myopain 2010 Abstracts; October 3-7, 2010; Toledo, Spain. Abstract 39.

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00371137     History of Changes
Other Study ID Numbers: 06-008 
Study First Received: August 30, 2006
Results First Received: September 8, 2011
Last Updated: December 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Jazz Pharmaceuticals:
Body pain
joint pain
muscular pain

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 04, 2016