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2024-516174-30-01CompletedPhase 2

Investigation of treating chronic fatigue syndrome after COVID with pharmacotherapy (pregabalin) or complex rehabilitation

Investigation of pregabalin therapy and complex rehabilitation in treating chronic fatigue associated with post-COVID syndrome

Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Oct 2024

Next steps

Brief summary (registry, in English)

Assessment of efficacy for pregabalin and complex rehabilitation in treating chronic fatigue syndrome associated with post-COVID syndrome

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
132 (actual)
First submitted
10 Sept 2024
Start date
8 Mar 2023
Lead sponsor
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
EU CT number
2024-516174-30-01
EudraCT number
2022-000433-16

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 132
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent treatment with opioids or other antiepileptic drugs (including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine);

Other illness

  • 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;

Other

  • Pregnant or breastfeeding women;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory ReicherWarsawPolandCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.