Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

NCT ID: NCT01584934

Last Updated: 2022-12-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sodium oxybate

Patient group receives sodium oxybate as treatment.

Group Type: EXPERIMENTAL

Sodium oxybate

Intervention Type: 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.

Placebo

Patient group receives placebo as treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

An Mariman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Related Links

http://www.uzgent.be

Related Info

Other Identifiers

2011-006336-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012/197

Identifier Type: -

Identifier Source: org_study_id