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The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xyrem® | Drug | flexible dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Adverse Events | Number of subjects reporting adverse events. | Treatment Period (38 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Suncoast Internal Medicine Consultants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 24286114 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xyrem 4.5 g to 9.0 g | Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Auburn |
| Alabama |
| United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States |
| Orange County Clinical Trials | Anaheim | California | United States |
| Northern California Research | Carmichael | California | 95608 | United States |
| Med Investigations Inc. | Fair Oaks | California | United States |
| Nerve Pro Research | Irvine | California | United States |
| Arroyo Medical Group, Inc. | Pismo Beach | California | 93449 | United States |
| AppleMed Research | Miami | Florida | United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Sunrise Medical Research | Plantation | Florida | 33317 | United States |
| Clinical Research Group of St. Petersburg, Inc | St. Petersburg | Florida | United States |
| Tampa Medical Group, P.A. | Tampa | Florida | United States |
| Center for Arthiritis and Rheumatism | Vero Beach | Florida | United States |
| Florida Medical Clinic, P.A. | Zephyhills | Florida | United States |
| Drug Studies America | Marietta | Georgia | United States |
| Coeur d' Alene Arthritis Clinic | Coeur d'Alene | Idaho | United States |
| Fibromyalgia Treatment Centers of America | Chicago | Illinois | United States |
| Deerpath Physcians Group | Gurnee | Illinois | 60031 | United States |
| Balanced Health Research Center | Peoria | Illinois | 61614 | United States |
| Graves - Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| Center for Arthiritis & Osteoporosis | Elizabethtown | Kentucky | United States |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | United States |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | United States |
| Louisiana Sleep Foundation | Baton Rouge | Louisiana | United States |
| Capital Clinical Rsearch Asociates | Rockville | Maryland | United States |
| FutureCare Studies | Springfield | Massachusetts | 01103 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | United States |
| Professional Clinical Research, Inc. at Crystal Lake Health Center | Benzonia | Michigan | United States |
| Professional Clinical Research | Cadillac | Michigan | United States |
| Professional Clinical Research at Crystal Lake Health Center | Interlocken | Michigan | 49643 | United States |
| PCM Medical Services | Lansing | Michigan | 48917 | United States |
| Clinvest | Springfield | Missouri | 65807 | United States |
| School of Osteopathic Medicine | Cherry Hill | New Jersey | 08002 | United States |
| Anderson & Collins Clinical Research, Inc. | Edison | New Jersey | 08817 | United States |
| Upstate Clinical Research, LLC | Albany | New York | 12205 | United States |
| AAIR Research Center | Rochester | New York | 14618 | United States |
| North Shore University Hospital | Valley Stream | New York | United States |
| Appalachian Regional Medical Associates | Boone | North Carolina | United States |
| Carolina Bone and Joint | Charlotte | North Carolina | 28210 | United States |
| Duke University Medical Center | Durham | North Carolina | 27103 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Hill Top Physicians Inc./Hightop Medical Research Center | Cincinnati | Ohio | United States |
| Radiant Research | Mogadore | Ohio | 44260 | United States |
| Tulsa Clinical Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| PRO Research | Eugene | Oregon | 97401 | United States |
| School of Nursing | Portland | Oregon | United States |
| Tri State Medical Group, Inc. | Beaver | Pennsylvania | 15009 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Central Pennsylvania Clinical Research | Mechanicsburg | Pennsylvania | 17055 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Low Country Research Country | Charleston | South Carolina | 29406 | United States |
| Southern Orthopaedic Sports Medicine | Columbia | South Carolina | United States |
| Radiant Research, Greer | Greer | South Carolina | 29651 | United States |
| Rheumatology Consultants, PLLC | Knoxville | Tennessee | 37909 | United States |
| Walter F. Chase, MD PA | Austin | Texas | 78705 | United States |
| R/D Clinical Research, Inc. | Houston | Texas | 77074 | United States |
| Sun Research Institute | San Antonio | Texas | 78205 | United States |
| Radiant Research San Antonio Northeast | San Antonio | Texas | 78217 | United States |
| The University of Texas Health Science | San Antonio | Texas | 78229 | United States |
| Fatigue Consultation Center | Salt Lake City | Utah | 84102 | United States |
| Evergreen Hospital Medical Center | Kirkland | Washington | 98034 | United States |
| Pacific Rheumatology Associates, Inc. | Renton | Washington | 98055 | United States |
| Charleston Internal Medicine | Charleston | West Virginia | 25304 | United States |
| Rhumatologie | Amiens | France |
| CHU de Grenoble-Hopital Sud | Échirolles | France |
| Hopital Claude Huriez Service de medecine interne | Lille | France |
| Centre Catherine de Sienne unite d evaluation et de traitement de la douleur | Nantes | France |
| Hopital Hotel Dieu service de medicine interne | Paris | France |
| CHU Hopital de Rangueil | Toulouse | France |
| Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie | Böblingen | Germany |
| Intensivmedizin der Uniklinik Koln | Cologne | Germany |
| Praxis Dr. Wiedeking | Essen | Germany |
| Praxis fur Innere Medizin und Rheumatologie | Gräfelfing | Germany |
| Gemeinschaftspraxis Schmerzzentrum | Hamburg | Germany |
| Praxisklinik Dr. Weiss | Mannheim | Germany |
| Praxis Dr. Sohn | Schwalmtal | Germany |
| Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara | Pisa | Italy |
| Amphia Ziekenhuis | Breda | Netherlands |
| Hospital Santa Creu i Snt Pau | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Instituto Ferran de Reumatologia | Barcelona | Spain |
| Hospital Universitario de Guadalajara | Guadalajara | Spain |
| Hospital Civil de Malaga | Málaga | Spain |
| Hospital Central de Asturias | Oviedo | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | Spain |
| Lever Chambers Centre for Health | Bolton | United Kingdom |
| Kings College London | London | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xyrem 4.5 g to 9.0 g | Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Reporting Adverse Events | Number of subjects reporting adverse events. | Posted | Number | Participants | Treatment Period (38 weeks) |
|
|
|
38 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xyrem 4.5 g to 9.0 g | Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses | 19 | 560 | 498 | 560 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gastrointestinal Hypomotility | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cholecystitis Chronic | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Breast Cancer in Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Mental Disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace Wang, MD, Director Clinical Development & Medical Monitor | Jazz Pharmaceuticals, Inc. | 650-496-3777 |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| D018771 | Arthralgia |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D059352 | Musculoskeletal Pain |
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| ID | Term |
|---|---|
| D012978 | Sodium Oxybate |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
Not provided
Not provided
| 50 - 64 years |
|
| >=65 years |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Spain |
|
| Netherlands |
|
| Germany |
|
| Italy |
|
| United Kingdom |
|