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

Fibromyalgia Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371137
• Other study ID #: 06-008
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2006
• Last updated: December 21, 2011
• Start date: August 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2011
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 548
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Xyrem®
two doses
• Placebo
Oral Solution

Locations

Country	Name	City	State
United States	Upstate Clinical Research, LLC	Albany	New York
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Future Search Trials of Neurology Future Research Trials	Austin	Texas
United States	Walter M. Chase, MD	Austin	Texas
United States	CCR Trials	Berlin	New Jersey
United States	Graves - Gilbert Clinic	Bowling Green	Kentucky
United States	Providence Clinical Research	Burbank	California
United States	Northern California Research	Carmichael	California
United States	Charrleston Internal Medicine	Charleston	West Virginia
United States	Low Country Research Center	Charleston	South Carolina
United States	Carolina Bone and Joint	Charlotte	North Carolina
United States	Carolinas Research	Charlotte	North Carolina
United States	Clinsearch	Chattanooga	Tennessee
United States	School of Osteopathic Medicine	Cherry Hill	New Jersey
United States	Radiant Research	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Anderson & Collins Clinical Research, Inc.	Edison	New Jersey
United States	PRO Research	Eugene	Oregon
United States	Welborn Clinic	Evansville	Indiana
United States	Clinical Physiology Associates Clinical Study Center	Fort Meyers	Florida
United States	DFW Wellness	Fort Worth	Texas
United States	CRIA Research	Ft. Lauderdale	Florida
United States	Radiant Research, Greer	Greer	South Carolina
United States	Deerpath Physicians Group	Gurnee	Illinois
United States	Houston Sleep Center	Houston	Texas
United States	The Methodist Hospital Systems	Houston	Texas
United States	Rheumatology Associates of N. AL, PC	Huntsville	Alabama
United States	Investigative Clinical Research of Indiana, LLC	Indianapolis	Indiana
United States	Richard A. Neiman, MD, Inc.	Kirkland	Washington
United States	Rheumatology Consultants, PLLC	Knoxville	Tennessee
United States	PCM Medical Services	Lansing	Michigan
United States	Innovative Research	Largo	Florida
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Commonwealth Biomedical Reseach, LLC	Madisonville	Kentucky
United States	Central Pennsylvania Clinical Research	Mechanicsburg	Pennsylvania
United States	Medford Medical Clinic, LLP	Medford	Oregon
United States	Signal Point Clinical Research Center, LLC	Middletown	Ohio
United States	Radiant Research	Mogadore	Ohio
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Compass Research	Orlando	Florida
United States	Pasadena Rehabilitation Institute	Pasadena	California
United States	Balanced health Research Center	Peoria	Illinois
United States	Clinical Research Source, Inc.	Perrysburg	Ohio
United States	Arizona Research Center	Phoenix	Arizona
United States	Xenoscience, Inc. dba 21st Century Neurology	Phoenix	Arizona
United States	Arroyo Medical Group	Pismo Beach	California
United States	Sunrise Medical Research	Plantation	Florida
United States	Coastal Medical Research, Inc	Port Orange	Florida
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Pacific Rheumatolgy Associates, Inc.	Renton	Washington
United States	AAIR Research Center	Rochester	New York
United States	Sacramento Research Medical Group	Sacramento	California
United States	Fatigue Consultation Center	Salt Lake City	Utah
United States	Radiant Research San Antonio Northeast	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	The University of Texas Health Science Center	San Antonio	Texas
United States	Apex Research Institute	Santa Ana	California
United States	Sansum Clinic	Santa Barbara	California
United States	Clinvest	Springfield	Missouri
United States	FutureCare Studies	Springfield	Massachusetts
United States	Clayton Medical Associates	St. Louis	Missouri
United States	St. John's Mercy Health System	St. Louis	Missouri
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma
United States	Omega Medical Research	Warwick	Rhode Island
United States	Great Lakes Medical Research	Westfield	New York
United States	Robert E. Harris, MD Medical Corporation	Whittier	California
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (10)

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.

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.

Russell IJ, Holman AJ, Swick TJ, Alvarez-Horine S, Wang YG, Guinta D; Sodium Oxybate 06-008 FM Study Group. Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: results from a 14-week, randomized, double- — View Citation

Russell IJ, Perkins AT, Michalek JE; Oxybate SXB-26 Fibromyalgia Syndrome Study Group. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum — View Citation

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

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; Tol

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

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].

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

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	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.	Baseline to Week 14	No