Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) … (NCT05967052) | Clinical Trial Compass
TerminatedPhase 2
Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
Stopped: occurrence of scientific risk
Poland23 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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped early, and does that affect whether its findings about pregabalin or rehabilitation are trustworthy enough to guide my treatment?
2Since this was a Phase 2 trial studying pregabalin for Long COVID fatigue, what does that mean about how much is still unknown regarding its safety and effectiveness for someone in my situation?
3The trial measured fatigue using the MFI-20 questionnaire and walking distance over 6 minutes — based on those kinds of measures, how would you assess whether my fatigue and physical function are similar to what this study was looking at?
4One arm of this trial used complex rehabilitation rather than medication — is that something you'd consider for me, and how does it compare to what's currently available outside of a trial setting?
5Given that this trial was terminated and is no longer enrolling, are there other active studies or standard treatment options for Long COVID fatigue that you think I should be considering instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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