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

Multicenter, Randomized, Double-blind, Placebo-controlled Comparative Study of the Efficacy and Safety of the Drug Dimephosphon®, Concentrate for Solution for Intravenous Administration, 1 g, in Acute Ischemic Stroke Patients

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the 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:

1. Written informed consent was obtained from the patient or their legally authorized representative prior to study participation.
2. Age 35-80.
3. 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.
4. Verified by CT/MRI current hemispheric ischemic stroke.
5. NIHSS score ≥5 and ≤15 at screening.
6. Ability to comply with all protocol-specified procedures, prohibitions, and restrictions.
7. Willingness and ability to adhere to highly effective contraceptive methods as outlined in the study protocol.

Exclusion Criteria:

1. Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries
2. Vertebrobasilar stroke and/or development of acute insufficiency syndromes in the arteries of the vertebrobasilar system
3. A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study.
4. 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.
5. 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).
6. Surgery on the carotid arteries less than 1 year before screening.
7. History of stroke less than 1 year before screening.
8. Myocardial infarction less than 6 months before screening.
9. Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml/min).
10. Pregnancy or lactation.
11. Participation in another trial within 28 days prior to enrollment.
12. Use of prohibited medications.