Mexidol® Safety and Efficacy in Treatment of Hyperacute and Acute Ischemic Stroke (NCT07575984) | Clinical Trial Compass
RecruitingPhase 4
Mexidol® Safety and Efficacy in Treatment of Hyperacute and Acute Ischemic Stroke
Russia120 participantsStarted 2025-11-04
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. Presence of occlusion in the internal carotid artery (ICA) system at any level, including the middle cerebral artery (MCA) and anterior cerebral artery (ACA) (anterior circulation) and/or presence of neuroimaging signs, characteristic of acute cerebral ischemia (based on CT perfusion and/or MRI data in accordance with current Clinical Guidelines). Note: Presence of internal carotid artery (ICA) occlusion is not a mandatory criterion; neuroimaging signs of acute cerebral ischemia (CT perfusion/MRI) are sufficient for inclusion.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Infarct Volume at Visit 2 (Day 11)
Timeframe: Day 11 (Visit 2).
Trial details
NCT IDNCT07575984
SponsorPharmasoft
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-04
Contact for this trial
Yuriy E. Meshcherskiy, Medical Director, LLC "RPC "PHARMASOFT", Medical Director
. 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.
. 8\. 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.
Exclusion criteria
. 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).