Trial Outcomes & Findings for MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure (NCT NCT06221826)

NCT ID: NCT06221826

Last Updated: 2025-04-27

Results Overview

Schulte test \[work efficiency\]. Test methodology: the subject is successively shown 5 tables (5x5), in the cells of which numbers (from 1 to 25) are randomly located. It is required to show and name all the numbers in ascending order (from 1 to 25). The time spent on each table separately is recorded. Depending on the objectives, the excess of the standard (40-50 sec) time spent on each table and the dynamics of time indicators, or the average or total result of the examination for all five tables, are analyzed \[test time: min value 30.0 sec, max value N/A; higher scores mean a worse outcome\].

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome 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).
• Results posted on: 2025-04-27

Participant Flow

Participant milestones

Measure	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 Mexidol: 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
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=30 Participants	6 Participants n=30 Participants	31 Participants n=60 Participants
Age, Categorical >=65 years	5 Participants n=30 Participants	24 Participants n=30 Participants	29 Participants n=60 Participants
Age, Continuous	63.9 years STANDARD_DEVIATION 10.3 • n=30 Participants	66.6 years STANDARD_DEVIATION 9.4 • n=30 Participants	65.3 years STANDARD_DEVIATION 9.8 • n=60 Participants
Sex: Female, Male Female	13 Participants n=30 Participants	17 Participants n=30 Participants	30 Participants n=60 Participants
Sex: Female, Male Male	17 Participants n=30 Participants	13 Participants n=30 Participants	30 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Russia	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants
Cognitive status [MoCA]	19.1 units on a scale STANDARD_DEVIATION 2.26 • n=30 Participants	19.6 units on a scale STANDARD_DEVIATION 1.83 • n=30 Participants	19.35 units on a scale STANDARD_DEVIATION 2.05 • n=60 Participants
The Rehabilitation Routing Scale (RRS)	3.9 units on a scale STANDARD_DEVIATION 0.4 • n=30 Participants	4.1 units on a scale STANDARD_DEVIATION 0.5 • n=30 Participants	4.0 units on a scale STANDARD_DEVIATION 0.5 • n=60 Participants

PRIMARY outcome

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).

Schulte test [work efficiency]. Test methodology: the subject is successively shown 5 tables (5x5), in the cells of which numbers (from 1 to 25) are randomly located. It is required to show and name all the numbers in ascending order (from 1 to 25). The time spent on each table separately is recorded. Depending on the objectives, the excess of the standard (40-50 sec) time spent on each table and the dynamics of time indicators, or the average or total result of the examination for all five tables, are analyzed [test time: min value 30.0 sec, max value N/A; higher scores mean a worse outcome].

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Аssessment of Attentiveness and Performance Day 1	94.9 seconds Interval 69.35 to 114.95	71.2 seconds Interval 65.15 to 87.9
Аssessment of Attentiveness and Performance Day 10	75 seconds Interval 60.9 to 95.7	68.15 seconds Interval 62.15 to 88.65
Аssessment of Attentiveness and Performance Day 66	71.7 seconds Interval 56.65 to 102.3	63 seconds Interval 55.73 to 82.95

PRIMARY outcome

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

The Montreal Cognitive Assessment (MoCA test) [31 point scale: min value 0, max value 30, higher scores mean a better outcome]

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Dynamics of Cognitive Status	23.8 score on a scale Standard Deviation 2.6	22.9 score on a scale Standard Deviation 3.0

PRIMARY outcome

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

The Beck Depression Inventory (BDI scale) [64 point scale: min value 0, max value 63, higher scores mean a worse outcome]

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Severity of Depression	7.5 score on a scale Standard Deviation 4.5	11.4 score on a scale Standard Deviation 5.6

PRIMARY outcome

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

The Hospital Anxiety and Depression Scale (HADS) [22 point scale: min value 0, max value 21, higher scores mean a worse outcome]

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Reduction in Anxiety	2.6 score on a scale Standard Deviation 2.4	4.4 score on a scale Standard Deviation 2.4

PRIMARY outcome

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

The Post Intensive Care Syndrome (PICS) score [21 point scale: min value 0, max value 10 with 0,5 point scale division, higher scores mean a worse outcome]

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Severity of Post Intensive Care Syndrome	0.02 score on a scale Standard Deviation 0.09	0.3 score on a scale Standard Deviation 0.6

PRIMARY outcome

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

The Rivermead index [16 point scale: min value 0, max value 15, higher scores mean a better outcome]

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Dynamics of Level of Mobility	10.3 score on a scale Standard Deviation 2.8	8.0 score on a scale Standard Deviation 2.8

PRIMARY outcome

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

The Rehabilitation Routing Scale (RRS) [7 point scale: min value 0, max value 6, higher scores mean a worse outcome]

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Dynamics of the Level of Life	2.9 score on a scale Standard Deviation 0.7	3.3 score on a scale Standard Deviation 0.6

PRIMARY outcome

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

The Muscle Strength Quantitative Rating (MRC) Scale [6 point scale: min value 0, max value 5, higher scores mean a better outcome]

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Severity and Dynamics of Muscle Strength	3.3 score on a scale Standard Deviation 5.1	2.1 score on a scale Standard Deviation 2.2

PRIMARY outcome

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.

Systolic cerebral blood flow velocity (Vs) was measured in сm/sec using transcranial Doppler ultrasonography (TCD). Measurements were taken for each participant at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [Normal values: min 35 сm/sec, max 95 сm/sec]

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points Before infusion	72.6 сm/sec Standard Deviation 18.41	80.03 сm/sec Standard Deviation 33.49
Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points Start of the infusion	72.23 сm/sec Standard Deviation 17.68	80.8 сm/sec Standard Deviation 33.09
Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points Start of the Schulte test	74.6 сm/sec Standard Deviation 18.73	83.57 сm/sec Standard Deviation 34.3
Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points End of the Schulte test	76.83 сm/sec Standard Deviation 17.76	80.87 сm/sec Standard Deviation 31.98
Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points End of the infusion	78.53 сm/sec Standard Deviation 17.78	83.57 сm/sec Standard Deviation 32.29

PRIMARY outcome

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.

The Overshoot Coefficient (OC) is a ratio reflecting the change in systolic cerebral blood flow velocity before and after specific stimuli. It was calculated based on transcranial Doppler measurements at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [It's calculated by the formula OC=(Vo-Vs)/Vs, the norm is not less than 1.12]

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points End of the Schulte test	1.26 ratio Standard Deviation 0.05	1.27 ratio Standard Deviation 0.04
Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points Before infusion	1.25 ratio Standard Deviation 0.05	1.27 ratio Standard Deviation 0.05
Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points Start of the infusion	1.26 ratio Standard Deviation 0.04	1.27 ratio Standard Deviation 0.04
Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points Start of the Schulte test	1.25 ratio Standard Deviation 0.05	1.27 ratio Standard Deviation 0.04
Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points End of the infusion	1.27 ratio Standard Deviation 0.05	1.28 ratio Standard Deviation 0.04

SECONDARY outcome

Timeframe: Throughout the study [From Day 1 up to Day 66]

Registration of adverse events related to Mexidol and significant differences in vital signs between groups

Outcome measures

Measure	Main (Mexidol and Standard Treatment) n=30 Participants 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 Mexidol: Neurocytoprotector	Control n=30 Participants 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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	0 Adverse events	0 Adverse events

Adverse Events

Main (Mexidol and Standard Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Meshcherskiy Y.E., Medical director

Pharmasoft

Phone: +7(495)626-47-55

Email: meshcherskiy_y@pharmasoft.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place