Actively Recruiting
Mexidol® Safety and Efficacy in Treatment of Hyperacute and Acute Ischemic Stroke
Led by Pharmasoft · Updated on 2026-05-13
120
Participants Needed
9
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Mexidol® Safety and Efficacy in Treatment of Hyperacute and Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form (patient or legal representative) or medical board decision
- Men and women aged 18 to 90 years
- First-ever hemispheric ischemic stroke confirmed by CT or MRI
- Occlusion in the internal carotid artery system or neuroimaging signs of acute cerebral ischemia
- Time from stroke symptom onset or last known well to randomization no more than 36 hours
- No significant pre-stroke disability (modified Rankin Scale 0-1)
- NIH Stroke Scale score 6 to 20 with motor arm and/or leg weakness of at least 2 points on the affected side
- Agreement to use effective contraception during the study and for 3 weeks after completion
- Healthy volunteers aged 18 to 45 years with normal clinical, laboratory, and instrumental exams
- Healthy volunteers must have normal hemodynamic parameters and BMI 18.5 to 30 kg/m2
- Healthy volunteers must abstain from alcohol during the study and agree to contraception
You will not qualify if you...
- Allergy to ethylmethylhydroxypyridine succinate or Mexidol® components
- Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
- Unable to take oral medications
- Contraindications to CT or MRI (e.g., pacemakers, implants, severe claustrophobia)
- Unable to undergo contrast imaging
- Received or planned thrombolytic therapy or thrombectomy for current stroke
- Recurrent ischemic stroke
- Complete irreversible occlusion of internal carotid artery
- No signs of acute ischemic brain injury on imaging
- Intracranial hemorrhage or brain tumors, arteriovenous malformations, abscess, aneurysm
- Brain edema causing displacement (malignant infarction)
- Lesion in vertebrobasilar system
- Suspected or history of subarachnoid hemorrhage
- History of hemorrhagic or unspecified stroke
- Bleeding tendency or recent deep vein thrombosis/pulmonary embolism
- Traumatic brain injury within 6 months
- Brain or spinal surgery within 5 years
- Need for surgery during study
- History of epilepsy, severe cognitive impairment, Parkinson's, or demyelinating diseases
- Severe aphasia or related clinical signs
- Recent myocardial infarction (within 3 months)
- Severe heart failure or unstable angina
- Very high blood pressure (SBP ≥200 mmHg or DBP ≥100 mmHg)
- Severe COPD or uncontrolled diabetes
- Significant kidney or liver impairment
- History of HIV, syphilis, or hepatitis B/C
- Recent acute infections
- Recent use of interfering medications or ethylmethylhydroxypyridine succinate
- Autoimmune diseases requiring immunosuppressants
- Recent or active cancer except cured basal cell carcinoma or carcinoma in situ
- Other severe unstable conditions or life expectancy less than 6 months
- Pregnancy or breastfeeding
- History of substance abuse or psychiatric disorders
- Participation in another trial within 3 months
- Other conditions precluding safe study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
First City Clinical Hospital named after E.E. Volosevich
Arkhangelsk, Russia, 163000
Actively Recruiting
2
Ivanovo Regional Clinical Hospital
Ivanovo, Russia, 153040
Actively Recruiting
3
Regional Clinical Hospital
Ryazan, Russia, 390039
Actively Recruiting
4
Hospital for War Veterans
Saint Petersburg, Russia, 193079
Actively Recruiting
5
City Hospital № 40 of Kurortny District
Saint Petersburg, Russia, 197706
Actively Recruiting
6
Smolensk Regional Clinical Hospital
Smolensk, Russia, 214018
Actively Recruiting
7
Regional Clinical Hospital
Tver', Russia, 170036
Actively Recruiting
8
Regional Clinical Hospital
Yaroslavl, Russia, 150062
Actively Recruiting
9
Zhukovskiy Regional Clinical Hospital,
Zhukovskiy, Russia, 140180
Actively Recruiting
Research Team
Y
Yuriy E. Meshcherskiy, Medical Director, LLC "RPC "PHARMASOFT", Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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