FibromyalgiaPhase 3NCT00423605
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
A Phase 3 study testing Xyrem® in people with Fibromyalgia, run by Jazz Pharmaceuticals at 91 sites in 7 countries.
Trial summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Xyrem®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 91 sitesin 7 countries
- Study dates
- Dec 2006to Jan 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
91 sites in 7 countries.
91 sites in 7 countries
United States66 sites
Upstate Clinical Research, LLC
Albany, New York, 12205
Advanced Clinical Research Institute
Anaheim, California, 92801
Orange County Clinical Trials
Anaheim, California
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Suncoast Internal Medicine Consultants
Auburn, Alabama
Walter F. Chase, MD PA
Austin, Texas, 78705
Louisiana Sleep Foundation
Baton Rouge, Louisiana
Tri State Medical Group, Inc.
Beaver, Pennsylvania, 15009
Professional Clinical Research, Inc. at Crystal Lake Health Center
Benzonia, Michigan
Appalachian Regional Medical Associates
Boone, North Carolina
Graves - Gilbert Clinic
Bowling Green, Kentucky, 42101
Professional Clinical Research
Cadillac, Michigan
Northern California Research
Carmichael, California, 95608
Low Country Research Country
Charleston, South Carolina, 29406
Charleston Internal Medicine
Charleston, West Virginia, 25304
Carolina Bone and Joint
Charlotte, North Carolina, 28210
School of Osteopathic Medicine
Cherry Hill, New Jersey, 08002
Fibromyalgia Treatment Centers of America
Chicago, Illinois
Hill Top Physicians Inc./Hightop Medical Research Center
Cincinnati, Ohio
Coeur d' Alene Arthritis Clinic
Coeur d'Alene, Idaho
Southern Orthopaedic Sports Medicine
Columbia, South Carolina
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Duke University Medical Center
Durham, North Carolina, 27103
Anderson & Collins Clinical Research, Inc.
Edison, New Jersey, 08817
Center for Arthiritis & Osteoporosis
Elizabethtown, Kentucky
PRO Research
Eugene, Oregon, 97401
Med Investigations Inc.
Fair Oaks, California
Radiant Research, Greer
Greer, South Carolina, 29651
Deerpath Physcians Group
Gurnee, Illinois, 60031
R/D Clinical Research, Inc.
Houston, Texas, 77074
Professional Clinical Research at Crystal Lake Health Center
Interlocken, Michigan, 49643
Nerve Pro Research
Irvine, California
Evergreen Hospital Medical Center
Kirkland, Washington, 98034
Rheumatology Consultants, PLLC
Knoxville, Tennessee, 37909
PCM Medical Services
Lansing, Michigan, 48917
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431
Drug Studies America
Marietta, Georgia
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055
AppleMed Research
Miami, Florida
Radiant Research
Mogadore, Ohio, 44260
Compass Research
Orlando, Florida, 32806
Balanced Health Research Center
Peoria, Illinois, 61614
Arizona Research Center
Phoenix, Arizona, 85023
Arroyo Medical Group, Inc.
Pismo Beach, California, 93449
Sunrise Medical Research
Plantation, Florida, 33317
School of Nursing
Portland, Oregon
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Pacific Rheumatology Associates, Inc.
Renton, Washington, 98055
AAIR Research Center
Rochester, New York, 14618
Capital Clinical Rsearch Asociates
Rockville, Maryland
Fatigue Consultation Center
Salt Lake City, Utah, 84102
Sun Research Institute
San Antonio, Texas, 78205
Radiant Research San Antonio Northeast
San Antonio, Texas, 78217
The University of Texas Health Science
San Antonio, Texas, 78229
FutureCare Studies
Springfield, Massachusetts, 01103
Clinvest
Springfield, Missouri, 65807
Clinical Research Group of St. Petersburg, Inc
St. Petersburg, Florida
Tampa Medical Group, P.A.
Tampa, Florida
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104
North Shore University Hospital
Valley Stream, New York
Center for Arthiritis and Rheumatism
Vero Beach, Florida
Omega Medical Research
Warwick, Rhode Island, 02886
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610
Florida Medical Clinic, P.A.
Zephyhills, Florida
Germany7 sites
Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie
Böblingen
Intensivmedizin der Uniklinik Koln
Cologne
Praxis Dr. Wiedeking
Essen
Praxis fur Innere Medizin und Rheumatologie
Gräfelfing
Gemeinschaftspraxis Schmerzzentrum
Hamburg
Praxisklinik Dr. Weiss
Mannheim
Praxis Dr. Sohn
Schwalmtal
Spain7 sites
Hospital Santa Creu i Snt Pau
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Instituto Ferran de Reumatologia
Barcelona
Hospital Universitario de Guadalajara
Guadalajara
Hospital Civil de Malaga
Málaga
Hospital Central de Asturias
Oviedo
Hospital Clinico Universitario de Santiago
Santiago de Compostela
France6 sites
Rhumatologie
Amiens
CHU de Grenoble-Hopital Sud
Échirolles
Hopital Claude Huriez Service de medecine interne
Lille
Centre Catherine de Sienne unite d evaluation et de traitement de la douleur
Nantes
Hopital Hotel Dieu service de medicine interne
Paris
CHU Hopital de Rangueil
Toulouse
United Kingdom3 sites
Lever Chambers Centre for Health
Bolton
Kings College London
London
Freeman Hospital
Newcastle upon Tyne
About this study
Official title: A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Read the detailed 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.
- Conditions
- Fibromyalgia
- Being tested
- Xyrem®
- Keywords
- FMS, Fibro, Pain, Body Pain, Tenderness, Joint pain, Stiffness, Muscular Pain
- Medical subject headings
- Fibromyalgia, Pain, Arthralgia, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xyrem®Drug
flexible dosing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Xyrem® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Adverse Events
Number of subjects reporting adverse events.
Measured: Treatment Period (38 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423605
- Sponsor's protocol ID
- 06-010
- Status last verified
- Mar 2012
- First submitted
- 16 Jan 2007
- Last updated
- 30 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Spaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.
Spaeth M, Alegre C, Perrot S, Wang Y, Guinta DR, Alvarez-Horine S, Russell I; Sodium Oxybate Fibromyalgia Study Group. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia. Arthritis Res Ther. 2013 Nov 11;15(6):R185. doi: 10.1186/ar4375.
PubMed 24286114
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT00423605
- Acronym / sponsor ID
- 06-010
- Conditions
- Fibromyalgia
- Keywords
- FMS, Fibro, Pain, Body Pain, Tenderness, Joint pain, Stiffness, Muscular Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Posted 20 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Xyrem® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xyrem®flexible dosing | Drug | 1 |
Primary outcome
Number of Subjects Reporting Adverse Events
Time frame: Treatment Period (38 weeks)
Number of subjects reporting adverse events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationSpaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.
- Derived from this study: PubMed 24286114Spaeth M, Alegre C, Perrot S, Wang Y, Guinta DR, Alvarez-Horine S, Russell I; Sodium Oxybate Fibromyalgia Study Group. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia. Arthritis Res Ther. 2013 Nov 11;15(6):R185. doi: 10.1186/ar4375.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
91 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xyrem® in people with Fibromyalgia, run by Jazz Pharmaceuticals at 91 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Germany, Spain, France, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Reporting Adverse Events (time frame: Treatment Period (38 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00423605, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.