Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

Sponsor

University Hospital, Ghent (Other)

Overall Status

Unknown status

CT.gov ID

NCT01584934

Collaborator

UCB Pharma (Industry)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome	Drug: Sodium oxybate Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Measurement of the effect of sodium oxybate on fatigue with questionnaires. [before treatment (baseline evaluation)]
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. [after 42 days of first treatment]
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. [after 42 days of second treatment (113 days after baseline)]
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).

Secondary Outcome Measures

Effect of sodium oxybate on sleepiness. [before treatment (baseline evaluation)]
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 [after 42 days of first treatment]
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. [after 42 days of second treatment (113 days after baseline)]
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. [before treatment (baseline evaluation)]
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. [42 days after first treatment]
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. [42 days after second treatment (113 days after baseline)]
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. [before treatment (baseline evaluation)]
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. [42 days after first treatment]
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. [42 days after second treatment (113 days after baseline)]
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. [before treatment (baseline evaluation)]
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. [42 days after first treatment]
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. [42 days after second treatment (113 days after baseline)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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