A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
Public ClinicalTrials.gov record NCT00423813. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00423813
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 573 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2006 (Type not available)
- Primary completion
- Apr 2009 (Actual)
- Completion
- Jun 2009 (Actual)
- Last update posted
- Jan 24, 2012
2006 – 2009
United States locations
- U.S. sites
- 71
- U.S. states
- 27
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| East Alabama Arthritis Center | Auburn | Alabama | 36830 | — |
| Capstone Clinical Trials, Inc. | Birmingham | Alabama | 35209 | — |
| Drug Research and Analysis Corporation | Montgomery | Alabama | 36106 | — |
| dba 21st Century Neurology | Phoenix | Arizona | 85004 | — |
| Orange County Clinical Trials | Anaheim | California | 92801 | — |
| Providence Clinical Research | Burbank | California | 91505 | — |
| Med Investigations, Inc. | Fair Oaks | California | 95628 | — |
| North Orange County Research Institute, Inc. | Fullerton | California | 92835 | — |
| Nerve Pro Research | Irvine | California | 92618 | — |
| Northridge Neurological Center | Northridge | California | 91325 | — |
| Arroyo Medical Group | Pismo Beach | California | 93449 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Sacramento Research Medical Group | Sacramento | California | 95825 | — |
| University of CT, Health Center | Farmington | Connecticut | 06030-1310 | — |
| Center for Musculoskeletal Pain Research | Gainesville | Florida | 32610 | — |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | — |
| Suncoast Internal Medicine Consultants | Largo | Florida | 33773 | — |
| AppleMed Research | Miami | Florida | 33155 | — |
| Compass Research | Orlando | Florida | 32806 | — |
| Clinical Research Group of St. Petersburg, Inc. | St. Petersburg | Florida | 33707 | — |
| Tampa Medical Group, P.A. | Tampa | Florida | 33614 | — |
| Lake Rheumatology | Tavares | Florida | 32778 | — |
| Center for Arthritis and Rheumatism | Vero Beach | Florida | 32962 | — |
| Florida Medical Clinic, P.A., Clinical Research Division | Zephyrhills | Florida | 33542 | — |
| Drug Studies America | Marietta | Georgia | 30066 | — |
| Coeur d'Alene Arthritis Clinic | Coeur d'Alene | Idaho | 83814 | — |
| Fibromyalgia Treatment Centers of America | Chicago | Illinois | 60641 | — |
| Investigative Clinical Research of Indiana, LLC | Indianapolis | Indiana | 46254 | — |
| Cotton-O'neil Clinical Research center | Topeka | Kansas | 66606 | — |
| Center for Arthritis and Osteoporosis | Elizabethtown | Kentucky | 42701 | — |
| Central Kentucky Research Associates,Inc. | Lexington | Kentucky | 40509 | — |
| Bluegrass Internal Medicine | Owensboro | Kentucky | 42303 | — |
| Louisiana Sleep Foundation | Baton Rouge | Louisiana | 70809 | — |
| Capital Clinical Research Associates | Rockville | Maryland | 20852 | — |
| Professional Clinical Research at Cyrstal Lake Health Center | Benzonia | Michigan | 49616 | — |
| Quest Research Institute | Bingham Farms | Michigan | 48025 | — |
| Professional Clinical Research | Cadillac | Michigan | 49601 | — |
| Professional Clinical Research at Crystal Lake Health Center | Interlochen | Michigan | 49643 | — |
| Arthritis Associates | Hattiesburg | Mississippi | 39402 | — |
| Medex Healthcare Research, Inc | St Louis | Missouri | 63117 | — |
| St. John's Mercy Health System | St Louis | Missouri | 63141 | — |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | — |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | — |
| Alan Lichtbroun, MD | East Brunswick | New Jersey | 08816 | — |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87109 | — |
| North Shore University Hospital, North Shore Pain Services | Valley Stream | New York | 11580 | — |
| Great Lakes Medical Research | Westfield | New York | 14787 | — |
| Appalachian Regional Medical Associates | Boone | North Carolina | 28607-0000 | — |
| Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU | Greenville | North Carolina | 27834 | — |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Hightop Medical Research Center | Cincinnati | Ohio | 45224 | — |
| Health Research Associates, LLC (HRA) | Cleveland | Ohio | 44121 | — |
| Ohio State U, Immunology/Rheumatology William Davis Medical Research Center | Columbus | Ohio | 43210 | — |
| Cleveland Neuro-Sleep Research Institute Inc. | Middleburg Heights | Ohio | 44130 | — |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | — |
| Oregon Health Sciences University School of Medicine | Portland | Oregon | 97239 | — |
| Tri State Medical Group, Inc. | Beaver | Pennsylvania | 15009 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Founders Research | Yardley | Pennsylvania | 19067 | — |
| Southern Orthopaedic Sports Medicine | Columbia | South Carolina | 29204 | — |
| Neurology Future Research Trials | Austin | Texas | 78756 | — |
| DFW Wellness | Fort Worth | Texas | 76108 | — |
| The Methodist Hospital System | Houston | Texas | 77030 | — |
| Houston Sleep Center | Houston | Texas | 77063 | — |
| R/D Clinical Research, Inc. | Houston | Texas | 77074 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| University of Texas Health Science Center | San Antonio | Texas | 78229 | — |
| Arthritis & Osteoporosis Center of South Texas | San Antonio | Texas | 78232 | — |
| Clinical Health Research, LLC | Sugarland | Texas | 77479 | — |
| Arthritis and Osteoporosis Clinic, Research Center of Central Texas | Waco | Texas | 76708 | — |
| Alben Goldstein, MD, FACP | Arlington | Virginia | 22204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00423813, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 24, 2012 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00423813 live on ClinicalTrials.gov.