RecruitingPhase 3NCT07167550

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


Sponsor

Tatchempharmpreparaty, JSC

Enrollment

184 participants

Start Date

Sep 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke


Eligibility

Min Age: 35 YearsMax Age: 80 Years

Inclusion Criteria7

  • 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 Criteria12

  • 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.

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Interventions

DRUGDimephosphon®

1 g/ml, concentrate for solution for intravenous infusion

DRUGPlacebo

Placebo IV solution


Locations(6)

State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital

Vsevolozhsk, Leningradskaya Oblast', Russia

State Budgetary Healthcare Institution "Research Institute - Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky" of the Ministry of Health of the Krasnodar region

Krasnodar, Russia

Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba"

Moscow, Russia

The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological Agency

Moscow, Russia

Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"

Saint Petersburg, Russia

State Budgetary Healthcare Institution "City Hospital No. 4 of Sochi" of the Ministry of Healthcare of the Krasnodar Region

Sochi, Russia

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NCT07167550


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