Clinical trial NCT01584934: Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
Official title: The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
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
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2012-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Measurement of the effect of sodium oxybate on fatigue with questionnaires.
timeFrame: before treatment (baseline evaluation)
measure: Measurement of the effect of sodium oxybate on fatigue with questionnaires.
timeFrame: after 42 days of first treatment
measure: Measurement of the effect of sodium oxybate on fatigue with questionnaires.
timeFrame: after 42 days of second treatment (113 days after baseline)
Secondary outcomes:
measure: Effect of sodium oxybate on sleepiness.
timeFrame: before treatment (baseline evaluation)
measure: Effect of sodium oxybate on sleepiness
timeFrame: after 42 days of first treatment
measure: Effect of sodium oxybate on sleepiness.
timeFrame: after 42 days of second treatment (113 days after baseline)
measure: Effect of sodium oxybate on sleep quality.
timeFrame: before treatment (baseline evaluation)
measure: Effect of sodium oxybate on sleep quality.
timeFrame: 42 days after first treatment
measure: Effect of sodium oxybate on sleep quality.
timeFrame: 42 days after second treatment (113 days after baseline)
measure: Effect of sodium oxybate on general health.
timeFrame: before treatment (baseline evaluation)
measure: Effect of sodium oxybate on general health.
timeFrame: 42 days after first treatment
measure: Effect of sodium oxybate on general health.
timeFrame: 42 days after second treatment (113 days after baseline)
measure: Effect of sodium oxybate on pain.
timeFrame: before treatment (baseline evaluation)
measure: Effect of sodium oxybate on pain.
timeFrame: 42 days after first treatment
measure: Effect of sodium oxybate on pain.
timeFrame: 42 days after second treatment (113 days after baseline)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: An Mariman, MD
role: PRINCIPAL_INVESTIGATOR
References: