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

NCT05939622 | Completed Phase 4

• 1 other identifier: BRAINMAX_2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthenia; COVID-19; Functional MRI; Cognitive Impairment

Keywords

Asthenia; COVID-19; Chronic fatigue syndrome; Functional MRI; Cognitive impairment; Brain fog; BRAINMAX

Outcome Measures

Primary Outcomes (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.

  From baseline to Visit 2 (day 10)

Secondary Outcomes (3)

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

  From baseline to Visit 2 (day 10)

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

  From baseline to Visit 2 (day 10)

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

  From baseline to Visit 2 (day 10)

Study Arms (2)

fMRI with subsequent injection of active drug (Ethyl methyl hydroxypyridine succinate + Meldonium)

EXPERIMENTAL

Arm 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

Other: Structural and functional MRI; Drug: Ethyl methyl hydroxypyridine succinate + Meldonium

fMRI with subsequent injection of placebo

PLACEBO COMPARATOR

Arm 2 (n=15) performed structural and functional MRI and received Placebo in the same way.

Other: Structural and functional MRI; Drug: Placebo

Interventions

Structural and functional MRI OTHER

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

Also known as: fMRI

fMRI with subsequent injection of active drug (Ethyl methyl hydroxypyridine succinate + Meldonium); fMRI with subsequent injection of placebo

Ethyl methyl hydroxypyridine succinate + Meldonium DRUG

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

Also known as: BRAINMAX®

fMRI with subsequent injection of active drug (Ethyl methyl hydroxypyridine succinate + Meldonium)

Placebo DRUG

Placebo was used in the same way

fMRI with subsequent injection of placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Anaemia
• 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

Sponsors & Collaborators

• Promomed, LLC: lead

Study Sites (1)

Federal State Budgetary Research Institution "Research Centre of Neurology"

Moscow, Russia

Location

MeSH Terms

Conditions

Asthenia; COVID-19; Cognitive Dysfunction; Fatigue Syndrome, Chronic; Mental Fatigue

Interventions

3-(2,2,2-trimethylhydrazine)propionate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Fatigue; Behavioral Symptoms; Behavior

Study Officials

• Marine Tanashyan, MD, PhD

  Federal State Budgetary Research Institution "Research Centre of Neurology"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 11, 2023
• Study Start: May 18, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)