The effects of sodium oxybate in patients with chronic fatigue syndrome
- Conditions
- Chronic fatigue syndromeMedDRA version: 16.0Level: LLTClassification code 10066564Term: Chronic fatigueSystem Organ Class: 100000004867Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-006336-23-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- Patients suffering from chronic, disabling, unexplained fatigue with at least four minor criteria for CFS, according to the 1994 Fukuda case definition
- Negative screening for FMS according to the American College of Rheumatology (ACR) classification criteria
- 18 = age = 65
- 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 a double barrier method of contraception
- Written, signed and dated informed consent must be obtained from each patient
- Patient able to understand and to comply with the requirements of the study
-Willing to abstain from taking any medication or treatment prohibited in the protocol
-Willing to abstain from using alcohol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- FMS
- Presence of an inflammatory rheumatic disease or a painful disorder other than FMS
- Fatigue that is explained by established medical or psychiatric causes
- 18 > age > 65
- Apnea/hypopnea index (AHI) = 15 on PSG (exempted if receiving continuous positive airway pressure CPAP with documented good compliance and control of AHI on PSG)
- Any other respiratory disease (chronic obstructive pulmonary disease, asthma,…)
- Deficiency in succinic semialdehyde dehydrogenase
- Porphyria
- Unsufficiently controlled hypertension (= 140/90 mmHg)
- Heart failure
- Liver or kidney disease (hepatitic transaminases AST and ALT > 5x upper limit of normal ULN (graad 3 AE), Total bilirubin > 1.5 mg/dl (graad 3 AE) of normal direct bilirubin; serum creatinine level > 2.0 mg/dl)
- Any primary neurological disease, seizure disorder or epilepsy
- Any past history of narcolepsy
- Sodium oxybate treatment in the past
- Any history of substance abuse (including abuse of alcohol)
- Inability to withdraw from psychoactive drugs
- Current use of sedatives (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
- Inability to adopt a double barrier method of contraception
- Occupation that requires night-shift work
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Polysomnography (PSG): on night 42 and 112<br>Multiple Sleep Latency Test (MSLT): on day 43 and 113;Main Objective: To evaluate in CFS patients the effect of sodium oxybate on fatigue;Secondary Objective: To evaluate in CFS patients <br>- the effect of sodium oxybate on subjective and objective measures of sleep characteristics, sleepiness, general health and pain <br>- the interdependence of sleep quality and fatigue<br>;Primary end point(s): Effect of sodium oxybate on fatigue
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Effect of sodium oxybate on subjective and objective measures of sleep characteristics, sleepiness, general health and pain <br>- the interdependence of sleep quality and fatigue<br>;Timepoint(s) of evaluation of this end point: Questionnaires: on day 43 and 113