Actively Recruiting
Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
Led by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Updated on 2023-11-14
132
Participants Needed
1
Research Sites
227 weeks
Total Duration
On this page
Sponsors
N
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient gave written informed consent to participate in the study
- Men or women aged 18 to 65 years at the time of consent
- At least 6 months have passed since confirmed SARS-CoV-2 infection
- Meets diagnostic criteria for chronic fatigue syndrome (CFS) according to National Academy of Medicine (2015)
- Women either unable to have children or using effective contraception with a negative pregnancy test during the study
- Agrees to participate in all study activities
- Able to understand study information and provide informed consent prior to screening
You will not qualify if you...
- Vital functions disorders
- Known allergy to pregabalin or any formulation ingredients such as lactose
- Moderate or severe depression at baseline or during treatment
- Receiving opioids or antiepileptic drugs including tramadol, buprenorphine, morphine, oxycodone, gabapentin, or duloxetine
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
Research Team
B
Beata Tarnacka, Prof, Md, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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