The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke

This study is a multicenter, randomized, double-blind, placebo-controlled trial. The purpose of the study is to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke. The study includes a screening period (Visit 1, up to 48 hours) and a treatment period (Visits 2-4). Subjects will be randomized into 2 groups in a 1:1 ratio: Group A (investigational drug Dimephosphon®) and Group B (placebo). Key inclusion criteria: verified by CT/MRI current hemispheric ischemic stroke, NIHSS score ≥5 and ≤15 at screening. The study will assess clinical outcomes using standardized scales including NIHSS, mRS, MMSE, MoCA and EQ-5D.

Inclusion criteria

• Written informed consent was obtained from the patient or their legally authorized representative prior to study participation.
• Age 35-80.
• Patients must exhibit neurological manifestations consistent with acute ischemic stroke, with a documented onset-to-intervention interval ranging from 24 to 72 hours at the time of scheduled initial administration of the investigational drug.
• Verified by CT/MRI current hemispheric ischemic stroke.
• NIHSS score ≥5 and ≤15 at screening.
• Ability to comply with all protocol-specified procedures, prohibitions, and restrictions.
• Willingness and ability to adhere to highly effective contraceptive methods as outlined in the study protocol.

Exclusion criteria

• Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries
• Vertebrobasilar stroke and/or development of acute insufficiency syndromes in the arteries of the vertebrobasilar system
• A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study.
• The presence of anatomical abnormalities of the cerebral vessels (arteriovenous malformations, cavernous malformations, aneurysms, atresia of at least one of the extracranial arteries) according to the anamnesis or CT/MRI data.
• Progression of neurological symptoms of stroke, defined as an increase in the NIHSS score by 4 points at the second assessment (immediately before randomization) from the value obtained at the first assessment (immediately after signing the informed consent form).
• Surgery on the carotid arteries less than 1 year before screening.
• History of stroke less than 1 year before screening.
• Myocardial infarction less than 6 months before screening.
• Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml/min).
• Pregnancy or lactation.
• Participation in another trial within 28 days prior to enrollment.
• Use of prohibited medications.