Status:
RECRUITING
The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke
Lead Sponsor:
Tatchempharmpreparaty, JSC
Conditions:
Stroke
Acute Stroke
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke
Detailed Description
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT07167550
Start Date
September 6 2025
End Date
April 30 2026
Last Update
September 11 2025
Active Locations (6)
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1
State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital
Vsevolozhsk, Leningradskaya Oblast', Russia, 188643
2
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, 350086
3
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba"
Moscow, Russia, 117198
4
The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological Agency
Moscow, Russia, 117513