Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01584934
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01584934
Study Brief:
Protocol Section:
NCT01584934