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

P

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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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