Clinical Trials Logo
  1. Home
  2. Chronic Fatigue Syndrome
  3. NCT05967052

Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation — POSTCOVID  

Chronic Fatigue Syndrome Clinical Trial

Official title:
Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05967052
Study type Interventional
Source National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Contact Beata Tarnacka, Prof, Md, PhD
Phone 22 6709176
Email klinika.rehabilitacji@spartanska.pl
Status Recruiting
Phase Phase 2
Start date October 24, 2023
Completion date March 1, 2028
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05454683 - Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome N/A
Completed NCT01686074 - Motor Control in Chronic Fatigue Syndrome and Fibromyalgia N/A
Completed NCT02075489 - Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans N/A
Completed NCT01651754 - Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome N/A
Completed NCT00540254 - Behavioral Insomnia Therapy With Chronic Fatigue Syndrome Phase 1/Phase 2
Active, not recruiting NCT00071162 - Genetics of Fibromyalgia N/A
Withdrawn NCT04870476 - Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome N/A
Completed NCT05730660 - Quercetin Phytosome® Chronic Fatigue Syndrome N/A
Recruiting NCT04542161 - Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Phase 2
Recruiting NCT03807973 - Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes. Phase 1
Recruiting NCT05719493 - Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +) N/A
Terminated NCT01730495 - Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome Phase 2
Completed NCT01156909 - B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome Phase 2
Completed NCT01650636 - Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process N/A
Completed NCT01046370 - A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia N/A
Completed NCT00100412 - Hyporeactivity and Gulf War Illness N/A
Recruiting NCT06128967 - A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial Phase 3
Completed NCT02669212 - Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health N/A
Not yet recruiting NCT06011135 - Exploring Worry in CFS/ME
Completed NCT03844412 - Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments Phase 2