Trial Outcomes & Findings for Study of Efficacy and Safety of MEXIDOL® in Ischemic Stroke Therapy (NCT NCT02793687)

Last Updated: 2025-02-24

Results Overview

The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 6 (dead) \[6 point scale: min value 0, max value 6, higher scores mean a worse outcome\].

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

150 participants

Primary outcome timeframe

Visit 5 (67-71 Day).

Results posted on

2025-02-24

Participant Flow

Participants were recruited based on protocol requirements at 11 clinical sites between March 2015 and May 2016. The first participant was enrolled on 6 March, 2015 and the last participant was enrolled on 20 February, 2016.

Of 151 screened participants, 150 met inclusion criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	Mexidol® Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Placebo Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.
Overall Study STARTED	75	75
Overall Study COMPLETED	61	63
Overall Study NOT COMPLETED	14	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Efficacy and Safety of MEXIDOL® in Ischemic Stroke Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mexidol® n=75 Participants Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Placebo n=75 Participants Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	46 Participants n=7 Participants	81 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	29 Participants n=7 Participants	69 Participants n=5 Participants
Age, Continuous	63.893 years STANDARD_DEVIATION 10.246 • n=5 Participants	61.52 years STANDARD_DEVIATION 8.664 • n=7 Participants	62.70 years STANDARD_DEVIATION 9.53 • n=5 Participants
Age, Customized Age, sub-groups · < 60 years	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Age, Customized Age, sub-groups · 60-75 years	36 Participants n=5 Participants	40 Participants n=7 Participants	76 Participants n=5 Participants
Age, Customized Age, sub-groups · 76-90 years	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Region of Enrollment Russia	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 5 (67-71 Day).

Population: Per Protocol Population (all participant assigned to Mexidol or Placebo) for calculating the mean score of the 6-point Modified Rankin Scale (mRS) at Visit 5 after completion of the course of therapy for both arms.

Outcome measures

Outcome measures
Measure	Mexidol® n=61 Participants Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Placebo n=63 Participants Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.
Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms	1.098 score on a scale Standard Deviation 0.768	1.46 score on a scale Standard Deviation 0.947

SECONDARY outcome

Timeframe: Visit 5 (67-71 Day)

Population: Per Protocol Population (all participant assigned to Mexidol or Placebo) for calculating the mean score of the 15-item The National Institutes of Health Stroke Scale (NIHSS) at Visit 5 after completion of the course of therapy for both arms.

The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42 (severe stroke), with the minimum score being a 0 (no stroke symptoms).

Outcome measures

Outcome measures
Measure	Mexidol® n=61 Participants Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Placebo n=63 Participants Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.
Mean Score of the 15-item The National Institutes of Health Stroke Scale (NIHSS) at Visit 5 After Completion of the Course of Therapy for Both Arms	1.689 score on a scale Standard Deviation 1.397	2.222 score on a scale Standard Deviation 1.442

SECONDARY outcome

Timeframe: Time frame: Visit 5 (67-71 Day)

Population: Per Protocol Population (all participant assigned to Mexidol or Placebo) for calculating the mean score of the 10-item Barthel Index (BI) at Visit 5 after completion of the course of therapy for both arms.

The Barthel Index (BI) is a prominent measure that assesses an individual's ability to perform activities of daily living (ADL) independently, reflecting their mobility and functional capacity. BI evaluates ten specific activities: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation, and stair climbing. Each activity is weighted based on the level of assistance required, with scores assigned as follows: 10 (independent), 5 (some assistance), and 0 (dependent). The BI's scoring system favors mobility and continence, resulting in a total score ranging from 0 to 100, where a higher score indicates greater functional independence. The index is widely utilized for assessing functional disability, particularly in rehabilitation settings for stroke patients and individuals with neuromuscular or musculoskeletal disorders, as well as in oncology care.

Outcome measures

Outcome measures
Measure	Mexidol® n=61 Participants Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Placebo n=63 Participants Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.
Mean Score of the 10-item Barthel Index (BI) at Visit 5 After Completion of the Course of Therapy for Both Arms	96.066 score on a scale Standard Deviation 7.806	93.571 score on a scale Standard Deviation 12.229

SECONDARY outcome

Timeframe: Visit 5 (67-71 Day)

Population: Per Protocol Population (all participant assigned to Mexidol or Placebo) for calculating the mean score of the 21-item Beck Depression Inventory (BDI) at Visit 5 after completion of the course of therapy for both arms.

The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Each item is scored 0 to 3 points for a total score range of 0 to 63. This range includes interpretation from 0-9 points (as normal condition) to over 30 points (as severe depression).

Outcome measures

Outcome measures
Measure	Mexidol® n=61 Participants Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Placebo n=63 Participants Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.
Mean Score of the 21-item Beck Depression Inventory (BDI) at Visit 5 After Completion of the Course of Therapy for Both Arms.	2.213 score on a scale Standard Deviation 2.491	2.190 score on a scale Standard Deviation 2.693

SECONDARY outcome

Timeframe: Visit 5 (67-71 Day)

EQ-5D-3L is a concise, generic patient-reported outcome (PRO) measure of health consisting of five dimensions of health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (VAS). In the study version was used EQ-5D-3L that contains 3 severity levels for each dimension. The EQ VAS records the participants's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' (maximum indicated as 100 scores on VAS) and 'The worst health you can imagine' (minimum indicated as 0 on VAS).

Outcome measures

Outcome measures
Measure	Mexidol® n=61 Participants Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Placebo n=63 Participants Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.
Mean Score of on the EQ-5D-3L PRO Measure (VAS) at Visit 5 After Completion of the Course of Therapy for Both Arms.	83.82 score on a scale Standard Deviation 15.499	78.175 score on a scale Standard Deviation 17.52

Adverse Events

Mexidol®

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mexidol® n=75 participants at risk Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Placebo n=75 participants at risk Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.
Nervous system disorders Ischaemic stroke	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Nervous system disorders Haemorrhagic stroke	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Gastrointestinal disorders Cholecystitis acute	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).

Other adverse events

Additional Information

Meshcherskiy Y.E., Medical director

Pharmasoft

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Mexidol® n=75 participants at risk Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.	Placebo n=75 participants at risk Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.
Metabolism and nutrition disorders Gout	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	2.7% 2/75 • Number of events 2 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Metabolism and nutrition disorders Dyslipidaemia	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Metabolism and nutrition disorders Hepatic enzyme increased	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Nervous system disorders Depressed level of consciousness	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Vascular disorders Headache	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	2.7% 2/75 • Number of events 2 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Nervous system disorders Dizziness	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Musculoskeletal and connective tissue disorders Back pain	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	5.3% 4/75 • Number of events 4 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Musculoskeletal and connective tissue disorders Arthralgia	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Vascular disorders Hypertension	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Cardiac disorders Atrial fibrillation	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Vascular disorders Hypertensive crisis	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Cardiac disorders Sinus bradycardia	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Gastrointestinal disorders Gastric disorder	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Renal and urinary disorders Urinary tract infection	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Renal and urinary disorders Cystitis	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Renal and urinary disorders Pyelonephritis chronic	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Eye disorders Cataract	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Eye disorders Retinopathy	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiolipoma	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Skin and subcutaneous tissue disorders Abdominal wall abscess	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Surgical and medical procedures Rib fracture	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Injury, poisoning and procedural complications Contusion	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Infections and infestations Viral upper respiratory tract infection	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).
Vascular disorders Epistaxis	0.00% 0/75 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).	1.3% 1/75 • Number of events 1 • Not less than 71 days for each participant Safety analysis was performed using ITT-population data (for 150 participants).