Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
Primary Purpose
Chronic Fatigue Syndrome
Status
Withdrawn
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Sodium oxybate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring fatigue, sleep quality, Chronic, disabling, unexplained fatigue with at least 4 minor criteria for CFS, according to the 1994 Fukuda case definition
Eligibility 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
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium oxybate
Placebo
Arm Description
Patient group receives sodium oxybate as treatment.
Patient group receives placebo as treatment.
Outcomes
Primary Outcome Measures
Measurement of the effect of sodium oxybate on fatigue with questionnaires.
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.
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.
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Secondary Outcome Measures
Effect of sodium oxybate on sleepiness.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01584934
First Posted
April 23, 2012
Last Updated
December 14, 2022
Sponsor
University Hospital, Ghent
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT01584934
Brief Title
Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
Official Title
The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
incompatibilities over intellectual property
Study Start Date
June 2013 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
fatigue, sleep quality, Chronic, disabling, unexplained fatigue with at least 4 minor criteria for CFS, according to the 1994 Fukuda case definition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium oxybate
Arm Type
Experimental
Arm Description
Patient group receives sodium oxybate as treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient group receives placebo as treatment.
Intervention Type
Drug
Intervention Name(s)
Sodium oxybate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of the effect of sodium oxybate on fatigue with questionnaires.
Description
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Time Frame
before treatment (baseline evaluation)
Title
Measurement of the effect of sodium oxybate on fatigue with questionnaires.
Description
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Time Frame
after 42 days of first treatment
Title
Measurement of the effect of sodium oxybate on fatigue with questionnaires.
Description
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Time Frame
after 42 days of second treatment (113 days after baseline)
Secondary Outcome Measure Information:
Title
Effect of sodium oxybate on sleepiness.
Description
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.
Time Frame
before treatment (baseline evaluation)
Title
Effect of sodium oxybate on sleepiness
Description
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.
Time Frame
after 42 days of first treatment
Title
Effect of sodium oxybate on sleepiness.
Description
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.
Time Frame
after 42 days of second treatment (113 days after baseline)
Title
Effect of sodium oxybate on sleep quality.
Description
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.
Time Frame
before treatment (baseline evaluation)
Title
Effect of sodium oxybate on sleep quality.
Description
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.
Time Frame
42 days after first treatment
Title
Effect of sodium oxybate on sleep quality.
Description
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.
Time Frame
42 days after second treatment (113 days after baseline)
Title
Effect of sodium oxybate on general health.
Description
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.
Time Frame
before treatment (baseline evaluation)
Title
Effect of sodium oxybate on general health.
Description
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.
Time Frame
42 days after first treatment
Title
Effect of sodium oxybate on general health.
Description
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.
Time Frame
42 days after second treatment (113 days after baseline)
Title
Effect of sodium oxybate on pain.
Description
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.
Time Frame
before treatment (baseline evaluation)
Title
Effect of sodium oxybate on pain.
Description
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.
Time Frame
42 days after first treatment
Title
Effect of sodium oxybate on pain.
Description
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.
Time Frame
42 days after second treatment (113 days after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An Mariman, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
Learn more about this trial
Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
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