Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

NCT01584934 | Withdrawn Phase 4

• 2 other identifiers: 2012/1972011-006336-23
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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).

  before treatment (baseline evaluation)

• 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).

  after 42 days of first treatment

• 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).

  after 42 days of second treatment (113 days after baseline)

Secondary Outcomes (12)

• Effect of sodium oxybate on sleepiness.

  before treatment (baseline evaluation)

• Effect of sodium oxybate on sleepiness

  after 42 days of first treatment

• Effect of sodium oxybate on sleepiness.

  after 42 days of second treatment (113 days after baseline)

• Effect of sodium oxybate on sleep quality.

  before treatment (baseline evaluation)

• Effect of sodium oxybate on sleep quality.

  42 days after first treatment

Study Arms (2)

Sodium oxybate

EXPERIMENTAL

Patient group receives sodium oxybate as treatment.

Drug: Sodium oxybate

Placebo

PLACEBO COMPARATOR

Patient group receives placebo as treatment.

Drug: Placebo

Interventions

Sodium oxybate DRUG

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.

Sodium oxybate

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years or older;
• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Hospital, Ghent: lead
• UCB Pharma: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Fatigue; Sleep Initiation and Maintenance Disorders; Bronchiolitis Obliterans Syndrome

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• An Mariman, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 25, 2012
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1)