NCT05967052

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
22mo left

Started Oct 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Oct 2023Mar 2028

First Submitted

Initial submission to the registry

July 28, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 24, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

4.4 years

First QC Date

July 28, 2023

Last Update Submit

November 13, 2023

Conditions

Chronic Fatigue SyndromeCOVID-19, Long Haul

Keywords

chronic fatigue syndromeassociated with post-COVID syndrome

Outcome Measures

Primary Outcomes (2)

  • Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score

    Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score

    3 months and 6 months

  • Walking distance as a difference in score from the 6 Minute Walking Test

    Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline

    3 months and 6 months

Secondary Outcomes (11)

  • Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)

    3 months and 6 months

  • Change in the result obtained in the "Beck Depression Inventory (BDIII)" study

    3 months and 6 months

  • Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)

    3 months and 6 months

  • Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i

    3 months and 6 months

  • Change in the result of the CCT test

    3 months and 6 months

  • +6 more secondary outcomes

Other Outcomes (6)

  • The change in the profile of the examined inflammatory cytokines

    3 months and 6 months

  • Number of adverse events and the number and percentage of patients who experienced adverse events

    3 months and 6 months

  • Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events

    3 months and 6 months

  • +3 more other outcomes

Study Arms (4)

Pregabalin

EXPERIMENTAL
Drug: PregabalinBehavioral: Independent walking training

Pregabalin + Rehabilitation

EXPERIMENTAL
Drug: PregabalinBehavioral: Independent walking trainingBehavioral: Gradual movement therapy in the wardBehavioral: TelerehabilitationBehavioral: Psychotherapy

Rehabilitation + Placebo

EXPERIMENTAL
Behavioral: Independent walking trainingDrug: PlaceboBehavioral: Gradual movement therapy in the wardBehavioral: TelerehabilitationBehavioral: Psychotherapy

Placebo

PLACEBO COMPARATOR
Behavioral: Independent walking trainingDrug: Placebo

Interventions

PregabalinDRUG

Pregabalin pharmacotherapy

PregabalinPregabalin + Rehabilitation
Independent walking trainingBEHAVIORAL

Independent walking training

PlaceboPregabalinPregabalin + RehabilitationRehabilitation + Placebo
PlaceboDRUG

Placebo

PlaceboRehabilitation + Placebo
Gradual movement therapy in the wardBEHAVIORAL

Gradual movement therapy in the ward

Pregabalin + RehabilitationRehabilitation + Placebo
TelerehabilitationBEHAVIORAL

Telerehabilitation

Pregabalin + RehabilitationRehabilitation + Placebo
PsychotherapyBEHAVIORAL

Psychotherapy

Pregabalin + RehabilitationRehabilitation + Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum Wsparcia Badań Klinicznych

Warsaw, Masovian Voivodeship, 02-637, Poland

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, ChronicPost-Acute COVID-19 Syndrome

Interventions

PregabalinTelerehabilitationPsychotherapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCOVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services AdministrationBehavioral Disciplines and Activities

Study Officials

  • Beata Tarnacka, Prof, Md, PhD

    National Institute of Geriatrics, Rheumatology and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beata Tarnacka, Prof, Md, PhD

CONTACT

22 6709176klinika.rehabilitacji@spartanska.pl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 1, 2023

Study Start

October 24, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

PL(1)