The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke
| Condition(s) | Stroke, Acute Stroke, Ischemic Stroke, Cerebrovascular Disorders, Physiological Effects of Drugs |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke |
| Who can participate | 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 |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Lead sponsor | Tatchempharmpreparaty, JSC |
| Locations | Vsevolozhsk, Leningradskaya Oblast', Russia; Krasnodar, Russia; Moscow, Russia; Moscow, Russia; Saint Petersburg, Russia; Sochi, Russia |
| Start date | 2025-09-06 |
| NCT ID | NCT07167550 |
| Official listing | https://clinicaltrials.gov/study/NCT07167550 |