Sodium Oxybate in Patients With Chronic Fatigue Syndrome. - Full Text View

Purpose

Chronic fatigue syndrome (CFS) is a disabling, unexplained disorder characterized by physical and mental exhaustion. Complaints of disturbed and unrefreshing sleep are very common in CFS patients, however, the relationship between (disturbed) sleep quality and fatigue is still not fully elucidated. To evaluate the effect of sodium oxybate on fatigue and to explore the interdependence of sleep quality and fatigue in CFS, a double blind, randomized, placebo controlled cross-over trial with sodium oxybate is carried out in CFS patients.

The aim of this study is to address the issue of the effect of sodium oxybate on fatigue as a presenting symptom in chronic fatigue (CF) and CFS patients, in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the effect of sodium oxybate on sleepiness and general health in the same target population.

Zero-hypothesis: there is no effect.

Condition	Intervention	Phase
Chronic Fatigue Syndrome	Drug: Sodium oxybate Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

Resource links provided by NLM:

MedlinePlus related topics: Chronic Fatigue Syndrome Club Drugs Fatigue

Drug Information available for: Sodium Oxybate

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Measurement of the effect of sodium oxybate on fatigue with questionnaires. [ Time Frame: before treatment (baseline evaluation) ] [ Designated as safety issue: No ]
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Measurement of the effect of sodium oxybate on fatigue with questionnaires. [ Time Frame: after 42 days of first treatment ] [ Designated as safety issue: No ]
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Measurement of the effect of sodium oxybate on fatigue with questionnaires. [ Time Frame: after 42 days of second treatment (113 days after baseline) ] [ Designated as safety issue: No ]
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).

Secondary Outcome Measures:

Effect of sodium oxybate on sleepiness. [ Time Frame: before treatment (baseline evaluation) ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on sleepiness [ Time Frame: after 42 days of first treatment ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on sleepiness. [ Time Frame: after 42 days of second treatment (113 days after baseline) ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on sleep quality. [ Time Frame: before treatment (baseline evaluation) ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on sleep quality. [ Time Frame: 42 days after first treatment ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on sleep quality. [ Time Frame: 42 days after second treatment (113 days after baseline) ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on general health. [ Time Frame: before treatment (baseline evaluation) ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on general health. [ Time Frame: 42 days after first treatment ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on general health. [ Time Frame: 42 days after second treatment (113 days after baseline) ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on pain. [ Time Frame: before treatment (baseline evaluation) ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on pain. [ Time Frame: 42 days after first treatment ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Effect of sodium oxybate on pain. [ Time Frame: 42 days after second treatment (113 days after baseline) ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.

Estimated Enrollment:	65
Study Start Date:	June 2013
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sodium oxybate Patient group receives sodium oxybate as treatment.	Drug: Sodium oxybate Treatment is started and continued for 6 weeks at patient's home. Patients receive 3g/night during the first week, and 4,5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4,5 g/night for 1 week, followed by 3g/night for 1 week. The next 2 weeks, patients are not treated.
Placebo Comparator: Placebo Patient group receives placebo as treatment.	Drug: Placebo Placebo treatment is started and continued for 6 weeks at patient's home. Patients receive 3 g/night during the first week and 4.5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4.5 g/night for 1 week, followed by 3 g/night for 1 week. The next 2 weeks, patients are not treated.

Arms

Assigned Interventions

Experimental: Sodium oxybate

Patient group receives sodium oxybate as treatment.

Drug: Sodium oxybate

Treatment is started and continued for 6 weeks at patient's home. Patients receive 3g/night during the first week, and 4,5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4,5 g/night for 1 week, followed by 3g/night for 1 week. The next 2 weeks, patients are not treated.

Placebo Comparator: Placebo

Patient group receives placebo as treatment.

Drug: Placebo

Placebo treatment is started and continued for 6 weeks at patient's home. Patients receive 3 g/night during the first week and 4.5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4.5 g/night for 1 week, followed by 3 g/night for 1 week. The next 2 weeks, patients are not treated.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients suffering from chronic, disabling, unexplained fatigue with at least 4 minor criteria for CFS, according to the 1994 Fukuda case definition;
Negatively screened for fibromyalgia syndrome(FMS) according to the American College of Rheumatology (ACR) classification criteria;
18 years or older;
65 years or less;
Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the trial and has to employ an acceptable method of birth control (double barrier method of contraception);
Written, signed and dated informed consent must be obtained from each patient;
Patient able to understand and follow the requirements of the study
Willing to abstain from taking any medication or treatment prohibited in the protocol

Exclusion Criteria:

FMS;
Presence of an inflammatory rheumatic disease or a painful disorder other than FMS;
Fatigue that is explained by medical or psychiatric causes;
Older than 65 or younger than 18 years of age;
Apnea/hypopnea index (AHI) > or equal to 15 on polysomnography (PSG) (exempted if receiving continuous positive airway pressure CPAP and shown good compliance)
Deficiency in succinic semialdehyde dehydrogenase;
Porphyria;
Breathing or lung problems;
Unsufficiently controlled hypertension (high blood pressure: > 140/90 mmHg);
Heart failure;
Liver or kidney problems (serum creatinine level > 2,0 mg/dl);
Presence of a seizure disorder or epilepsy;
Sodium oxybate treatment in the past;
Primary history of substance abuse (including abuse of alcohol);
Inability to withdraw from psychoactive drugs;
Current use of sedative (benzodiazepine and non-benzodiazepine GABA-ergic agonists), opioids or antidepressant medication or a drug-free interval of less than 4 weeks;
Female patient who is pregnant, lactating or has a positive pregnancy test result.
Occupation that requires night-shift work;
Willing to abstain from using alcohol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584934

Contacts

Contact: An Mariman, MD

An.Mariman@ugent.be

Locations

Belgium
Ghent University Hospital	Not yet recruiting
Ghent, Belgium, 9000
Contact: An Mariman, MD An.Mariman@ugent.be
Contact: Els Tobback, Ph.D. Els.Tobback@uzgent.be
Principal Investigator: An Mariman, MD

Sponsors and Collaborators

University Hospital, Ghent

UCB, Inc.

Investigators

Principal Investigator:

An Mariman, MD

Ghent University Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT01584934 History of Changes
Other Study ID Numbers:	2012/197, 2011-006336-23
Study First Received:	April 23, 2012
Last Updated:	February 1, 2013
Health Authority:	Belgium: Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:

fatigue
sleep quality
Chronic, disabling, unexplained fatigue with at least 4 minor criteria for CFS, according to the 1994 Fukuda case definition

Additional relevant MeSH terms:

Fatigue Syndrome, Chronic
Fatigue
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

Sodium Oxybate
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013