Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) … (NCT05967052) | Clinical Trial Compass
RecruitingPhase 2
Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
Poland132 participantsStarted 2023-10-24
Plain-language 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 in a new indication (post-COVID chronic fatigue syndrome).
Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days).
There will be 4 outpatient visits to the research center and 12 telephone consultations.
The procedures and assessments performed as part of the study are listed in the study schedule.
It is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm).
Patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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 criteria
✕
What they're measuring
1
Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score
Timeframe: 3 months and 6 months
2
Walking distance as a difference in score from the 6 Minute Walking Test
Timeframe: 3 months and 6 months
Trial details
NCT IDNCT05967052
SponsorNational Institute of Geriatrics, Rheumatology and Rehabilitation, Poland