Investigation of treating chronic fatigue syndrome after COVID with pharmacotherapy (pregabalin) or complex rehabilitation
Key facts
- Where
- Warsaw, LengyelországSee the site
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Lengyelország
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory ReicherWarsaw, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Trial code
- EU 2024-516174-30-01
- Record updated
- 2024. október 31.
- Original description
Assessment of efficacy for pregabalin and complex rehabilitation in treating chronic fatigue syndrome associated with post-COVID syndromeRead full original descriptionShow less
Investigation of pregabalin therapy and complex rehabilitation in treating chronic fatigue associated with post-COVID syndrome
Assessment of efficacy for pregabalin and complex rehabilitation in treating chronic fatigue syndrome associated with post-COVID syndrome
Inclusion: The patient correctly gave written informed consent to participate in the study; Men or women between the ages of 18 and 65 inclusive at the time of signing the informed consent; Patient after a minimum of 6 months from the documented detection of SARS-CoV-2 infection (document confirming the history of the disease, including a positive result of the PCR or antigen test, certificate of convalescence; medical documentation confirming the infection; the condition is also considered fulfilled in the case of documented infection asymptomatic); During the screening, the patient meets the criteria for the diagnosis of chronic fatigue syndrome (CFS) according to National Academy of Medicine (2015); Women: a) incapable of having children (post-menopausal or child-bearing, subjected to permanent sterilization); (b) of childbearing potential with a negative pregnancy test result at screening and using a highly effective method of contraception throughout the IMP use and for 7 days after the last IMP use; The patient agrees to participate in all activities provided for in the study; The patient is able to understand the information presented and give informed consent to participate in the study prior to screening.
Exclusion: Concurrent treatment with opioids or other antiepileptic drugs (including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine); Vital functions disorders; Documented hypersensitivity to pregabalin or any of the excipients of the formulation (i.e., lactose); Moderate or severe depression during treatment or present during psychiatric evaluation at baseline; Pregnant or breastfeeding women.