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

Pharmasoft

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke, Acute

Treatments: Drug: Mexidol

Study type: Interventional

Funder types: Industry

Identifiers

NCT06221826

MexidolNeuro2023

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Main (Mexidol and standard treatment)

Experimental group

Description:

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

Treatment:

Drug: Mexidol

Control

No Intervention group

Description:

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