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AstheniaPhase 4NCT05939622

Efficacy of the Therapy With BRAINMAX® Using fMRI for the Treatment of Patients With Asthenia After COVID-19

A Phase 4 study testing Structural and functional MRI and Ethyl methyl hydroxypyridine succinate + Meldonium in people with Asthenia and COVID-19, run by Promomed, LLC at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

to assess executive network using resting-state fMRI and patterns of brain activation using task fMRI with a cognitive paradigm, against the background of taking the drug in comparison with placebo in patients with post-COVID asthenic syndrome. Read more about this study

Who is it for?
Ages 25 to 50 years
Conditions the study is for
Asthenia, COVID-19, Functional MRI
What is being tested?
Structural and functional MRI and Ethyl methyl hydroxypyridine succinate + Meldonium
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteRussia
Study dates
18 May 2022to 20 Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients able to sign the patient informed consent form for the participation in the clinical study
  • Patients of both sexes of 25-50 years of age
  • Patient's negative test result for severe acute respiratory syndrome (SARS) -CoV-2 RNA obtained by polymerase chain reaction (PCR) method within 72 hours
  • COVID-19 diagnosis documented in the history more than 12 weeks ago*
  • Symptoms of Post-COVID-19 syndrome (asthenic state, feeling of energy loss and decreased functioning, intellectual function disorder, attention and memory disorder, emotional lability, reducing stress resistance) which appeared during or after COVID-19, retain for more than 12 weeks and cannot be explained by an alternative diagnosis
  • Patients capable of following the requirements of the Clinical Study Protocol
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  • Negative pregnancy test result (for women with the active childbearing potential)
  • MFI-20 scale score is more than 30 at the moment of screening.
  • Higher education.
  • Lack of decompensated somatic pathology
  • Lack of indications of the transferred/current disease of the nervous system

Who cannot join

  • Allergic reactions to the components of the study product
  • Taking prohibited drugs/dietary supplements during the previous randomization of the month
  • Severe hepatic failure
  • Severe renal failure
  • Chronic liver and hepatic diseases
  • Thyroid diseases
Show all 31Show fewer
  • Anaemia
  • Malignant tumour of any localization currently or during 5 years before the inclusion into the study except for completely treated carcinoma in situ
  • Autoimmune diseases
  • Other chronical diseases which, according to the investigator, can cause asthenia
  • Pregnancy or lactation period
  • Tuberculosis, cancers or positive reaction to the HIV infection, hepatitis B \& C, syphilis according to the history data
  • Severe eyesight and/or hearing disorders, serious articulation disorders and/or other deviations able to prevent the patient from adequate cooperation during the study)
  • Mental disorders in the history
  • Alcohol, drug abuse or drug dependence in the history
  • Patients which, according to the investigator, are obviously or probably incapable of understanding and evaluating this study information within the process of the informed consent form signing, including but not limited to with regard to expected risks and possible discomfort
  • Other diseases, symptoms or conditions not listed above, which, according to the investigator, are predicaments for the participation in the clinical study
  • The presence of contraindications for MRI
  • The presence of contraindications for taking the drug
  • Contraindications for MRI:
  • Electronic medical devices in the body (cardiomyostimulator and other)
  • Metal elements in the study area (prosthesis, clamp, fragment)
  • Invariable behavior of patients
  • Inability to remain still during MRI
  • Prohibited drugs/dietary supplements:
  • Ethyl methyl hydroxypyridine succinate and Meldonium (other than the one studied in the study)
  • Psychotropic medication
  • Drugs containing succinic acid and its salts
  • Drugs containing vitamin B6 and /or its derivatives
  • Antioxidants, antihypoxic drug and metabolic drugs
  • Nootropic drugs

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Federal State Budgetary Research Institution "Research Centre of Neurology"

    Moscow

Other trials in Russia

About this study

Official title: Prospective Randomized Double Blind Placebo Controlled Study of Efficacy of the Therapy With BRAINMAX® Using Functional Magnetic Resonance Imaging (fMRI) for the Treatment of Patients With Post-COVID Asthenic Syndrome

to assess executive network using resting-state fMRI and patterns of brain activation using task fMRI with a cognitive paradigm, against the background of taking the drug in comparison with placebo in patients with post-COVID asthenic syndrome.

Read the detailed description

A prospective, randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of therapy using functional MRI of the brain in the setting of neuroprotective therapy for the treatment of patients with chronic fatigue syndrome after COVID-19. The study included 30 patients matched by sex and age with confirmed coronavirus infection. All patients were examined with MFI-20, MoCa, FAS-10 scales, MRI using a Siemens MAGNETOM Prisma 3T scanner before and after a course of therapy with EMHPS-M or placebo (15 patients each) using resting state fMRI and with cognitive paradigm. First group received intramuscularly with the dosage regimen of 5 mL of solution (500 mg of ethyl methyl hydroxypyridine succinate + 500 mg of meldonium) once per day for 10 days. Second group received Placebo in the same way.

Being tested
Structural and functional MRI, Ethyl methyl hydroxypyridine succinate + Meldonium, Placebo
Keywords
Asthenia, COVID-19, Chronic fatigue syndrome, Functional MRI, Cognitive impairment, Brain fog, BRAINMAX
Medical subject headings
Asthenia, COVID-19, Cognitive Dysfunction, Fatigue Syndrome, Chronic, Mental Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structural and functional MRIOther

    Also called fMRI

    MRI using a Siemens MAGNETOM Prisma 3T scanner before and after a course of therapy, using resting state fMRI and with cognitive paradigm.

  • Ethyl methyl hydroxypyridine succinate + MeldoniumDrug

    Also called BRAINMAX®

    Ethyl methyl hydroxypyridine succinate 100.0 mg/mL, meldonium dihydrate - 100.0 mg/mL (Solution for intravenous and intramuscular administration)

  • PlaceboDrug

    Placebo was used in the same way

Study groups in NCT05939622
Study groupRoleWhat they receive
fMRI with subsequent injection of active drug (Ethyl methyl hydroxypyridine succinate + Meldonium)ExperimentalArm 1 (n=15) performed structural and functional MRI and received intramuscularly with the dosage regimen of 5 mL of solution (500 mg of ethyl methyl hydroxypyridine succinate + 500 mg of meldonium) once per day for 10 days
Receives: Other: Structural and functional MRI; Drug: Ethyl methyl hydroxypyridine succinate + Meldonium
fMRI with subsequent injection of placeboPlacebo comparatorArm 2 (n=15) performed structural and functional MRI and received Placebo in the same way.
Receives: Other: Structural and functional MRI; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changing patterns of brain activation using task fMRI with a cognitive paradigm

    Changing patterns of brain activation using task fMRI with a cognitive paradigm, against the background of taking Brainmax in comparison with placebo in patients with post-COVID asthenic syndrome.

    Measured: From baseline to Visit 2 (day 10)

Secondary outcomes (3)

  1. Asthenia on a scale Multidimensional Fatigue Inventory (MFI-20) after the completion of the parenteral therapy

    MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue.

    Mean decrease of MFI-20 asthenia scale score after the completion of the parenteral therapy

    Measured: From baseline to Visit 2 (day 10)

  2. Fatigue on a Fatigue Assessment Scale (FAS-10) scale after the completion of the parenteral therapy

    The FAS is a 10-item general fatigue questionnaire to assess fatigue. Five questions reflect physical fatigue and 5 questions (questions 3 and 6-9) mental fatigue. Subsequently, the total FAS score can be calculated by summing the scores on all questions (recoded scores for questions 4 and 10). The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.

    Score dynamics by FAS-10 scale after the completion of the parenteral therapy

    Measured: From baseline to Visit 2 (day 10)

  3. Cognitive function on a Montreal Cognitive Assessment (MoCA) scale after the completion of the parenteral therapy

    The Montreal Cognitive Assessment (MoCA) is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.

    Score dynamics by MoCA scale after the completion of the parenteral therapy

    Measured: From baseline to Visit 2 (day 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start18 May 2022
  3. Primary completion20 Dec 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05939622
Sponsor's protocol ID
BRAINMAX_2022
Status last verified
Jul 2023
First submitted
10 Jul 2023
Last updated
13 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Structural and functional MRI and Ethyl methyl hydroxypyridine succinate + Meldonium in people with Asthenia and COVID-19, run by Promomed, LLC at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changing patterns of brain activation using task fMRI with a cognitive paradigm (time frame: From baseline to Visit 2 (day 10)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05939622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.

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