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

NCT05939622 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-13

No results posted yet for this study

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

Interventions

OTHER

Structural and functional MRI

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

DRUG

Ethyl methyl hydroxypyridine succinate + Meldonium

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

DRUG

Placebo

Placebo was used in the same way

Sponsors & Collaborators

  • Promomed, LLC

    lead OTHER

Principal Investigators

  • Marine Tanashyan, MD, PhD · Federal State Budgetary Research Institution "Research Centre of Neurology"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2022-12-20
Completion
2022-12-20

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05939622 on ClinicalTrials.gov