MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2023-09-12

Brief Summary

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The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure

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Detailed Description

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Modern neurorehabilitation is a set of basic and adjuvant treatment methods that provide a modulating effect on the neurorestoration process. The range of basic rehabilitation practices includes kinesiotherapy, occupational therapy, speech therapy, and neuropsychology. Adjuvant methods include physiotherapeutic and medicinal methods. For this study, the investigators chose MEXIDOL® as an adjuvant metabolic medicine, which has the ability to modulate receptor complexes of brain membranes, in particular benzodiazepine, GABA, acetylcholine, enhancing their ability to bind to specific ligands. This pharmacodynamic feature of the drug can have a positive effect on the psycho-emotional state of patients, which in turn will increase motivation and, consequently, the success of the rehabilitation process

Conditions

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Ischemic Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Main (Mexidol and standard treatment)

Mexidol IV 500 mg for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; and standard treatment

Group Type EXPERIMENTAL

Mexidol

Intervention Type DRUG

Neurocytoprotector

Control

Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mexidol

Neurocytoprotector

Intervention Type DRUG

Other Intervention Names

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Ethylmethylhydroxypyridine Succinate

Eligibility Criteria

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Inclusion Criteria

* Acute Ischemic Stroke
* Montreal Cognitive Assessment (MoCA) test \>15; ≤22

Exclusion Criteria

* Under 18 years old
* Epilepsy
* Pregnancy
* Acute failure of one or more organ systems
* Purulent-inflammatory disease of any localization
* Participating in any other clinical trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No