Tests Dimephosphon against placebo in acute ischemic stroke
Tests whether Dimephosphon helps adults with acute ischemic stroke, compared with placebo.
Plain-language title generated from the registry record
Registry title: The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke
Key facts
- Where
- Krasnodar, Moscow, Saint Petersburg, Sochi, and Vsevolozhsk, RussiaSee the 6 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 35 and 80 years old?
Source: NCT07167550, who can take part
Where in 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 regionKrasnodar, RussiaNot yet recruiting
- Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba"Moscow, RussiaTaking people
- The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological AgencyMoscow, RussiaTaking people
- Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"Saint Petersburg, RussiaTaking people
- State Budgetary Healthcare Institution "City Hospital No. 4 of Sochi" of the Ministry of Healthcare of the Krasnodar RegionSochi, RussiaTaking people
- State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical HospitalVsevolozhsk, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tatchempharmpreparaty, JSC
- Trial code
- NCT07167550
- Record updated
- 11 September 2025
- Original description
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic strokeRead full original descriptionShow less
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
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: Surgery on the carotid arteries less than 1 year before screening; Myocardial infarction less than 6 months before screening; Participation in another trial within 28 days prior to enrollment; Use of prohibited medications; 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; 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); History of stroke less than 1 year before screening; Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml/min); 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; Pregnancy or lactation.