Chronic fatigue syndrome MedDRA version: 16.0 Level: LLT Classification code 10066564 Term: Chronic fatigue System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Xyrem 500 mg/ml oral solution
Product Name: Sodium oxybate
Pharmaceutical Form: Oral solution
INN or Proposed INN: Sodium Oxybate
CAS Number: 502-85-2
Other descriptive name: SODIUM OXYBAT
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate in CFS patients the effect of sodium oxybate on fatigue;Secondary Objective: To evaluate in CFS patients - the effect of sodium oxybate on subjective and objective measures of sleep characteristics, sleepiness, general health and pain - the interdependence of sleep quality and fatigue ;Primary end point(s): Effect of sodium oxybate on fatigue;Timepoint(s) of evaluation of this end point: Polysomnography (PSG): on night 42 and 112 Multiple Sleep Latency Test (MSLT): on day 43 and 113 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Effect of sodium oxybate on subjective and objective measures of sleep characteristics, sleepiness, general health and pain - the interdependence of sleep quality and fatigue ;Timepoint(s) of evaluation of this end point: Questionnaires: on day 43 and 113 | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
University Hospital Ghent
Outcome results
None listed