Status:
RECRUITING
Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
Lead Sponsor:
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Chronic Fatigue Syndrome
COVID-19, Long Haul
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the usefulness of pregabalin...
Eligibility Criteria
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 the 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
- 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;
- Concurrent treatment with opioids or other antiepileptic drugs (including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine);
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05967052
Start Date
October 24 2023
End Date
March 1 2028
Last Update
November 14 2023
Active Locations (1)
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1
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, Poland, 02-637