Clinical trial NCT06221826: MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure
Official title: Prospective Randomized Study of the Modulating Effect of MEXIDOL® as an Adjuvant Stimulant of the Cognitive-emotional Component of the Rehabilitation Treatment in Patients With Acute Cerebral Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke, Acute
Keywords: Ischemic Stroke
Acute Stroke
Cerebral stroke
Traumatic Brain Injury
Acute Cerebrovascular Accident
ACVA
Acute cerebral failure
Neuroprotection
Mexidol
Ethylmethylhydroxypyridine Succinate
Lead sponsor: Pharmasoft
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Аssessment of Attentiveness and Performance
timeFrame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66).
measure: Dynamics of Cognitive Status
timeFrame: Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66); Day 66 reported
measure: Severity of Depression
timeFrame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
measure: Reduction in Anxiety
timeFrame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
measure: Severity of Post Intensive Care Syndrome
timeFrame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
measure: Dynamics of Level of Mobility
timeFrame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
measure: Dynamics of the Level of Life
timeFrame: Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
measure: Severity and Dynamics of Muscle Strength
timeFrame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
measure: Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points
timeFrame: The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion.
measure: Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points
timeFrame: The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion.
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Throughout the study [From Day 1 up to Day 66]
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Brain Institute Clinic
state: Sverdlovsk Region
Study officials:
References:
citation: Belkin AA, Belkin VA, Vasilchenko IE, Pinchuk EA. [Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency]. Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(4):108-117. doi: 10.17116/jnevro2024124041108. Russian.