The Study of Efficacy and Safety of Mexidol® in Stroke Therapy (MIR)
- Registration Number
- NCT06437626
- Lead Sponsor
- Pharmasoft
- Brief Summary
The main purpose of the clinical trial is to assess efficacy and safety of Mexidol® in sequential treatment (solution for intravenous and intramuscular administration 50 mg/ml + film-coated tablets 250 mg) of patients in the acute and early recovery periods of ischemic stroke.
- Detailed Description
As the main purpose of the clinical study is to evaluate safety and efficacy of a neuroprotector (Mexidol®), it was crucial to develop strict protocol requirements that would help to avoid the challenges of estimation of neuroprotective effect for stroke therapy. The current treatment options for stroke are still limited and do not take into account rehabilitation period and patients' further quality of life.
As per protocol requirements, 313 participants were screened, 304 participants met all comprehensive eligibility criteria, 24 participants dropped out during the clinical trial period. The Modified Rankin Scale (mRS) was selected as the most representative primary outcome measuring tool due to the adequate representation of functional outcome. Additionally, the neuroprotective efficacy of Mexidol® was assessed for its ability to reduce stroke-related neurologic deficit and mood disorder symptoms, cognitive impairment, and to improve mobility after stroke.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
- Clinical diagnosis of first-ever hemispheric ischemic stroke (codes ICD-10: I63.0 - I63.9) with the time from onset of a stroke <48 hours.
- CT or MRI evidences of clinical diagnosis and no evidences of hemorrhagic stroke/hemorrhagic transformation of ischemic stroke.
- The written informed consent form (ICF) is signed and personally dated by the participant or by an impartial witness (by a person who is independent of the trial and cannot be unduly influenced by the people involved with the trial and who attends the informed consent process).
- The Modified Rankin Scale (mRS) score ≥3.
- The National Institutes of Health Stroke Scale (NIHSS) score from 9 to 15 points.
- Negative pregnancy test for women of childbearing age.
- Willingness to use reliable methods of contraception, and/or abstinence, for the duration of therapeutic product exposure.
- The ability to understand the purpose of research, risks associated with the research intervention, obligations and consequences of research participation and their right of withdrawing consent any time during the study.
- BMI (Body Mass Index) > 35.
- Recurrent or hemorrhagic stroke confirmed by CT/MRI.
- Hemorrhagic transformation of ischemic stroke.
- Parkinson's disease/parkinsonism.
- Progressive Multiple Sclerosis.
- Intractable Epilepsy.
- Demyelinating diseases of central nervous system.
- Hereditary and degenerative diseases of the central nervous system.
- Infectious diseases of central nervous system in medical history.
- Traumatic brain injury with severe neurocognitive impairment in medical history.
- Congenital malformations of the nervous system or any neurological disorders that can affect participant's capability (including cognitive and motor skills) to follow protocol procedures.
- Thrombolysis or thrombectomy treatment prior the enrollment.
- Medical history of severe allergies.
- Evidence of hypersensitivity reactions or intolerance associated with ethylmethylhydroxypyridine.
- Evidence of lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Acute surgical pathology.
- Evidence of clinically significant first identified disorder or disease that can affect participant's ability to participate in the clinical trial.
- Evidence of clinically significant severe disease/condition that can affect participant's ability to participate in the clinical trial: respiratory diseases, cardiovascular diseases (CVDs) including SAP ≥ 200 mm Hg and DAP ≥ 100 mm Hg, liver disease with elevation of ALT/AST > 2 × ULN, kidney disease (еGFR<30ml/min/1.73 m2), endocrine disorders and diseases, gastrointestinal diseases, pulmonary embolism (PE), deep vein thrombosis (DVT), floating thrombus, convulsive syndrome, uncontrolled hyperthermia, uncontrolled hyperglycemia.
- Medical history of severe mental disorder.
- Dementia of the Alzheimer type (DAT).
- Medical history of cancers within 5 years prior to enrollment.
- Medical history of alcohol/drug addiction.
- Pregnancy or breastfeeding.
- Prescription or use of prohibited medications within 2 weeks prior to enrollment.
- Positive HIV, syphilis, hepatitis B and C test.
- Positive COVID-19 test.
- Participation in another trial within 3 months prior to enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days Mexidol® Mexidol Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
- Primary Outcome Measures
Name Time Method Change from Baseline (Visit 0, Day 0-1) in Modified Rankin Scale (mRS) scores at Visit 4 (Day 71(+2)) Baseline, Day 71 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) \[6 point scale: min value 0, max value 6, higher scores mean a worse outcome\]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores).
- Secondary Outcome Measures
Name Time Method Percentage of subjects having Modified Rankin Scale (mRS) scores 0-1 (normal or lower degree of disability) at Visit 4 (Day 71(+2)) Day 71 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) \[6 point scale: min value 0, max value 6, higher scores mean a worse outcome\].
Change from Baseline (Visit 0, Day 0-1) in the National Institutes of Health Stroke Scale (NIHSS) score at Visit 4 (Day 71(+2)) Baseline, Day 71 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) \[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores).
Percentage of subjects having Modified Rankin Scale (mRS) scores >3 (higher degree of disability) at Visit 4 (Day 71(+2)) Day 71 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) \[6 point scale: min value 0, max value 6, higher scores mean a worse outcome\].
Change from Baseline (Visit 1, Day 1) in the Montreal Cognitive Assessment (MoCA) score at Visit 4 (Day 71(+2)) Baseline, Day 71 The Montreal Cognitive Assessment (MoCA) is a 30-point validated scale that covers multiple cognitive domains including spatiotemporal orientation, sustained attention, visuospatial function, executive function, verbal memory, language, naming, and abstract thinking \[31 point scale: min value 0, max value 30, higher scores mean a better outcome\].
Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).Change from Baseline (Visit 1, Day 1) in the Rivermead Mobility Index (RMI) score at Visit 4 (Day 71(+2)) Baseline, Day 71 The Rivermead Mobility Index (RMI) is a hierarchical mobility scale used in neurological rehabilitation. It includes 15 items related to bed mobility, transfers, walking, stair use, and running. The test is comprised of 14 questions, and the patient is then asked to stand for 10 seconds without any aid. Each response is scored yes or no with 1 point for each yes answer. The scores are summed with a range from 0 (poor mobility) to 15 (excellent mobility) \[16 point scale: min value 0, max value 15, higher scores mean a better outcome\].
Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).Change from Baseline (Visit 1, Day 1) in the Hospital Anxiety and Depression Scale (HADS) score at Visit 4 (Day 71(+2)) Baseline, Day 71 The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded \[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\].
Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).
Trial Locations
- Locations (19)
Tatarstan Republican Clinical Hospital
🇷🇺Kazan, Russian Federation
Russian National Research Medical University n.a. N. I. Pirogov
🇷🇺Moscow, Russian Federation
Kazan City Hospital № 7
🇷🇺Kazan, Russian Federation
St. Petersburg Clinical Hospital № 26
🇷🇺Saint Petersburg, Russian Federation
Vsevolozhsk Clinical Interdistrict Hospital
🇷🇺Vsevolozhsk, Russian Federation
Central Clinical Medical and Sanitary Unit n.a. V. A. Egorov
🇷🇺Ulyanovsk, Russian Federation
Federal Center for Brain and Neurotechnology
🇷🇺Moscow, Russian Federation
City Hospital № 40 of Kurortny District
🇷🇺Saint Petersburg, Russian Federation
Samara Regional Clinical Hospital n.a. V. D. Seredavin
🇷🇺Samara, Russian Federation
Rostov State Medical University
🇷🇺Rostov-on-Don, Russian Federation
Alexandrovskaya Hospital
🇷🇺Saint Petersburg, Russian Federation
Yaroslavl Clinical Hospital № 2
🇷🇺Yaroslavl, Russian Federation
Interregional Clinical Diagnostic Center
🇷🇺Kazan, Russian Federation
Almaty City Hospital № 7
🇰🇿Almaty, Kazakhstan
Kemerovo City Clinical Hospital № 11
🇷🇺Kemerovo, Russian Federation
Research Institute - Regional Clinical Hospital № 1
🇷🇺Krasnodar, Russian Federation
National Medical Research Center n.a. V. A. Almazov
🇷🇺Saint Petersburg, Russian Federation
Voronezh Regional Clinical Hospital № 1
🇷🇺Voronezh, Russian Federation
The first clinic of the Tashkent Medical Academy
🇺🇿Tashkent, Uzbekistan