The effects of sodium oxybate in patients with chronic fatigue syndrome

niversity Hospital Ghent0 个研究点开始时间: 2012年3月20日最近更新: 2014年10月7日

研究概览

暂无简介。

•- 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

•- 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

发起方

niversity Hospital Ghent