Mexidol® Safety and Efficacy in Treatment of Hyperacute and Acute Ischemic Stroke

NCT07575984 | Recruiting Phase 4

• 1 other identifier: PHS-PIL-DWI-001-MEX-SOL-TAB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

Brief Summary

The primary objective of this study is to further define the mechanisms of action of Mexidol® (solution for intravenous and intramuscular injection, 50 mg/ml) and Mexidol® FORTE 250 (film-coated tablets, 250 mg) in the hyperacute and acute periods of ischemic stroke, and to evaluate their impact on clinical and neuroimaging outcomes of the disease.

Conditions

Ischemic Stroke, Hyperacute; Ischemic Stroke, Acute; Cerebrovascular Accident (Stroke)

Keywords

Ischemic Stroke; Hyperacute Stroke; Acute Stroke; Cerebral Stroke; Acute Cerebrovascular Accident; ACVA; Acute cerebral failure; Cerebral Infarction; Neuroprotection; Mexidol; Ethylmethylhydroxypyridine Succinate; Antioxidants

Outcome Measures

Primary Outcomes (1)

• Infarct Volume at Visit 2 (Day 11)

  Evaluation of the ischemic lesion volume using Diffusion-Weighted Imaging (DWI).

  Day 11 (Visit 2).

Secondary Outcomes (12)

• Change in Infarct Volume from Baseline to Visit 2 (Day 11)

  Baseline (Visit 0) and Day 11 (Visit 2)

• Incidence of Symptomatic Hemorrhagic Transformation (sHT) by Visit 2 (Day 11)

  Up to Day 11 (Visit 2)

• Change in laboratory biomarkers (TNF-α, BDNF, NSE, GFAP, MMP-9, Caspase-3, VCAM-1, MBP, fibronectin)

  Baseline (Visit 0) and Day 11 (Visit 2)

• Assessment of coagulation parameters (D-dimer, fibrinogen).

  Baseline (Visit 0) and Day 11 (Visit 2)

• Metabolomic assessment (lactate, pyruvate, succinate, malate, fumarate, oxoglutarate, ATP, AMP, ADP, MDA, glutamate, GABA, glycine).

  Baseline (Visit 0) and Day 11 (Visit 2)

Study Arms (3)

Mexidol Group

EXPERIMENTAL

Patients receive Mexidol® solution followed by Mexidol® FORTE 250 tablets on top of standard background therapy.

Drug: Mexidol

Glycine Group

ACTIVE COMPARATOR

Patients receive Glycine sublingual tablets on top of standard background therapy.

Drug: Glycine

Healthy Volunteers

NO INTERVENTION

Healthy subjects included to obtain control baseline values of biomarkers.

Interventions

Mexidol DRUG

Phase 1 (Days 1-10): Mexidol® solution, 500 mg (10 ml) twice daily (total daily dose 1000 mg) administered via IV infusion in 100-200 ml of 0.9% NaCl solution for 10 days. Infusion rate: 40-60 drops per minute. Phase 2 (Days 11-70): Mexidol® FORTE 250 film-coated tablets, 250 mg three times daily (total daily dose 750 mg) for 60 days. Administered on top of standard background therapy in accordance with the 2024 Clinical Guidelines of the Ministry of Health of the Russian Federation for Ischemic Stroke and TIA.

Mexidol Group

Glycine DRUG

Glycine, 100 mg sublingual tablets, 1 g (10 tablets) daily for 5 days. Administered on top of standard background therapy in accordance with the 2024 Clinical Guidelines of the Ministry of Health of the Russian Federation for Ischemic Stroke and TIA.

Glycine Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated Informed Consent Form (ICF) by the patient or their legal representative (in case of physical inability to sign), and/or a Decision of the Medical Board.
• Men and women aged 18 to 90 years (inclusive) at the time of signing the ICF or Decision of the Medical Board.
• First-ever hemispheric ischemic stroke (ICD-10 codes: I63.0-I63.9), confirmed by neuroimaging (CT or MRI).
• Time from the onset of acute ischemic stroke symptoms or the time the patient was last known to be well (last known well, LKW) to randomization is no more than 36 hours.
• No significant pre-stroke disability (the patient is able to carry out all daily activities and duties without assistance, a score of 0-1 on the modified Rankin Scale (mRS)).
• Total National Institutes of Health Stroke Scale (NIHSS) score of 6 to 20 (inclusive) at screening, provided that the score for item 5a/b (Motor Arm: Left/Right) is at least 2 points on the paretic side and/or item 6a/b (Motor Leg: Left/Right) is at least 2 points on the paretic side.
• \. Agreement to use highly effective methods of contraception throughout the study and for 3 weeks after study completion. Eligible participants include: women of childbearing potential, who must have a negative pregnancy test and agree to use the following contraceptive methods: a barrier method (condom or occlusive cap \[diaphragm or cervical/vault cap\]) or a double-barrier method (condom or occlusive cap \[diaphragm or cervical/vault cap\] plus spermicide \[foam/gel/film/cream/suppository\]); women of non-childbearing potential with documented history of hysterectomy, tubal ligation, infertility, or postmenopausal status (at least 1 year of amenorrhea); fertile men who must agree to use barrier contraception; men with documented infertility or prior vasectomy.
• White male and female participants aged 18 to 45 years inclusive at the time of signing the Informed Consent Form (ICF).
• Verified "healthy" status based on standard clinical, laboratory, and instrumental examination methods.
• Ability to provide written informed consent prior to any screening procedures, and the ability, in the investigator's opinion, to comply with all study protocol requirements.
• Hemodynamic parameters: systolic blood pressure (SBP) within 100-130 mmHg, diastolic blood pressure (DBP) within 60-90 mmHg, heart rate (HR) 60-90 bpm, and respiratory rate (RR) 16-20 breaths per minute.
• Body Mass Index (BMI) from 18.5 to 30 kg/m² inclusive.
• Willingness to abstain from alcohol throughout the entire study period.
• Agreement to use highly effective methods of contraception throughout the entire study. Eligible participants include:
• women of childbearing potential, who must have a negative pregnancy test and agree to use the following contraceptive methods: a barrier method (condom or occlusive cap \[diaphragm or cervical/vault cap\]) or a double-barrier method (condom or occlusive cap \[diaphragm or cervical/vault cap\] plus spermicide \[foam/gel/film/cream/suppository\]); women of non-childbearing potential with documented history of hysterectomy, tubal ligation, infertility, or postmenopausal status (at least 1 year of amenorrhea); fertile men who must agree to use barrier contraception; men with documented infertility or prior vasectomy.

You may not qualify if:

• Hypersensitivity to ethylmethylhydroxypyridine succinate or any other components of the investigational product.
• Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
• Inability to take oral medications.
• Contraindications or inability to undergo CT/MRI procedures (including, but not limited to: permanent cardiac pacemakers/neurostimulators; inner ear prosthesis, ferromagnetic or electronic middle ear implants, hemostatic clips, cardiac valve prostheses, or any other metal-containing structures; ferromagnetic fragments; insulin pumps; severe claustrophobia).
• Inability to undergo contrast-enhanced imaging for any reason.
• Patients who have received or are scheduled to receive thrombolytic therapy or thrombectomy for the current episode of ischemic stroke.
• Recurrent ischemic stroke.
• Direct signs of irreversible total occlusion of the internal carotid artery (ICA) system at the relevant level within the current episode of ischemic stroke (based on CT/MRI data).
• Absence of neuroimaging signs of acute ischemic brain injury.
• Presence of any of the following neuroimaging (CT/MRI) findings:
• Intracranial hemorrhage;
• Hemorrhagic transformation of the cerebral infarction;
• Subarachnoid hemorrhage;
• Brain tumor;
• Arteriovenous malformation (AVM);

Sponsors & Collaborators

• Pharmasoft: lead

Study Sites (9)

First City Clinical Hospital named after E.E. Volosevich

Arkhangelsk, 163000, Russia

RECRUITING

Ivanovo Regional Clinical Hospital

Ivanovo, 153040, Russia

RECRUITING

Regional Clinical Hospital

Ryazan, 390039, Russia

RECRUITING

Hospital for War Veterans

Saint Petersburg, 193079, Russia

RECRUITING

City Hospital № 40 of Kurortny District

Saint Petersburg, 197706, Russia

RECRUITING

Smolensk Regional Clinical Hospital

Smolensk, 214018, Russia

RECRUITING

Regional Clinical Hospital

Tver', 170036, Russia

RECRUITING

Regional Clinical Hospital

Yaroslavl, 150062, Russia

RECRUITING

Zhukovskiy Regional Clinical Hospital,

Zhukovskiy, 140180, Russia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Cerebral Infarction

Interventions

emoxypine succinate; Glycine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yuriy E. Meshcherskiy, Medical Director, LLC "RPC "PHARMASOFT", Medical Director

CONTACT

007 (495) 626-47-55; pharmasoft@pharmasoft.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (9)