The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Measurement of the effect of sodium oxybate on fatigue with questionnaires.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sodium oxybate
Patient group receives sodium oxybate as treatment.
干预措施: Sodium oxybate (Drug)
Placebo
Patient group receives placebo as treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Measurement of the effect of sodium oxybate on fatigue with questionnaires.
时间窗: after 42 days of second treatment (113 days after baseline)
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
次要结局
- Effect of sodium oxybate on sleepiness.(after 42 days of second treatment (113 days after baseline))
- Effect of sodium oxybate on sleep quality.(42 days after second treatment (113 days after baseline))
- Effect of sodium oxybate on pain.(42 days after second treatment (113 days after baseline))
- Effect of sodium oxybate on general health.(42 days after second treatment (113 days after baseline))
- Effect of sodium oxybate on sleepiness(after 42 days of first treatment)