Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01584934
First received: April 23, 2012
Last updated: February 1, 2013
Last verified: February 2013
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Fatigue Syndrome, Chronic
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 July 29, 2014