Investigation of treating chronic fatigue syndrome after COVID with pharmacotherapy (pregabalin) or complex rehabilitation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

8 Mar 2023 → 30 Oct 2025

Decision date (initial)

2024-10-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Agencja Badań Medycznych

External identifiers

EU CT number

2024-516174-30-01

EudraCT number

2022-000433-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

Assessment of efficacy for pregabalin and complex rehabilitation in treating chronic fatigue syndrome associated with post-COVID syndrome

Secondary objectives 1

1. Assessment of pregabalin influence on selected cytokine levels in patients with chronic fatigue syndrome associated with post-COVID syndrome

Conditions and MedDRA coding

Chronic fatigue syndrome associated with post-COVID syndrome

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. The patient correctly gave written informed consent to participate in the study;
2. Men or women between the ages of 18 and 65 inclusive at the time of signing the informed consent;
3. 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);
4. During the screening, the patient meets the criteria for the diagnosis of chronic fatigue syndrome (CFS) according to National Academy of Medicine (2015);
5. 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.
6. The patient agrees to participate in all activities provided for in the study.
7. The patient is able to understand the information presented and give informed consent to participate in the study prior to screening.

Exclusion criteria 5

1. Vital functions disorders;
2. Documented hypersensitivity to pregabalin or any of the excipients of the formulation (i.e., lactose);
3. Moderate or severe depression during treatment or present during psychiatric evaluation at baseline;
4. Concurrent treatment with opioids or other antiepileptic drugs (including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine);
5. Pregnant or breastfeeding women;

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline.

Secondary endpoints 18

1. Change in the degree of satisfaction with life expressed as the result of the Life Satisfaction Scale (Juczyński) in the 3rd and 6th month of the study compared to the result on the day the study began.
2. Change in the result obtained in the "Beck Depression Inventory (BDIII)" in the 3rd and 6th month of the study compared to the result on the day the study began.
3. Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI) in the 3rd and 6th month of the study compared to the result on the day the study began.
4. Change in the degree of acceptance of the disease assessed by the Illness Acceptance Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day the study began.
5. Change in the CTT-1 and CTT-2 test result in the 3rd and 6th month of the study compared to the result on the day the study began.
6. Change in the result of the Wisconsin Card Sorting Test (WCST) in the 3rd and 6th month of the study compared to the result on the day the study began.
7. Change in the RFFT test result in the 3rd and 6th month of the study compared to the result on the day the study began.
8. Change in the result in the WAIS-R Digit Repetition subtest in the 3rd and 6th month of the study compared to the result on the day the study began.
9. Change in reaction time in the Stroop interference test in the 3rd and 6th month of the study compared to the result on the day the study began.
10. Change in the gait quality assessment in the 3rd and 6th month of the study compared to the result on the day the study began.
11. Change in walking speed in the 3rd and 6th month of the study compared to the result on the day the study began.
12. Change in reaction time expressed in the Peg Insertion Test in the 3rd and 6th month of the study compared to the result on the day the study began.
13. Change in the d2-R test result in the 3rd and 6th month of the study compared to the result on the day the study began.
14. Change in the score on the Athens Insomnia Scale in the 3rd and 6th month of the study compared to the score on the day the study began.
15. Change in the Mini-Cope result in the 3rd and 6th month of the study compared to the result on the day the study began.
16. The exploratory endpoint is the change in the profile of tested inflammatory cytokines in the 6th month of the study compared to the result before the start of the study. We allow for the possibility of additional exploratory endpoints during the study, before unblinding.
17. Security related endpoints: • Number of adverse events and the number and percentage of patients who experienced adverse events. • Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events. • Number of serious adverse events and number and proportion of patients with serious adverse events. • Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.
18. Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

Sponsor organisation

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

Address

Ul. Spartanska 1

City

Warsaw

Postcode

02-637

Country

Poland

Scientific contact point

Organisation

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

Contact name

Centrum Wsparcia Badań Klinicznych

Public contact point

Organisation

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

Contact name

Centrum Wsparcia Badań Klinicznych

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications