Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

December 14, 2022 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of sodium oxybate on sleepiness.
Time Frame: 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.
before treatment (baseline evaluation)
Effect of sodium oxybate on sleepiness
Time Frame: 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.
after 42 days of first treatment
Effect of sodium oxybate on sleepiness.
Time Frame: 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.
after 42 days of second treatment (113 days after baseline)
Effect of sodium oxybate on sleep quality.
Time Frame: 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.
before treatment (baseline evaluation)
Effect of sodium oxybate on sleep quality.
Time Frame: 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.
42 days after first treatment
Effect of sodium oxybate on sleep quality.
Time Frame: 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.
42 days after second treatment (113 days after baseline)
Effect of sodium oxybate on general health.
Time Frame: 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.
before treatment (baseline evaluation)
Effect of sodium oxybate on general health.
Time Frame: 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.
42 days after first treatment
Effect of sodium oxybate on general health.
Time Frame: 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.
42 days after second treatment (113 days after baseline)
Effect of sodium oxybate on pain.
Time Frame: 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.
before treatment (baseline evaluation)
Effect of sodium oxybate on pain.
Time Frame: 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.
42 days after first treatment
Effect of sodium oxybate on pain.
Time Frame: 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.
42 days after second treatment (113 days after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

UCB Pharma

Investigators

  • Principal Investigator: An Mariman, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Estimate)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/197
  • 2011-006336-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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