NCT07167550

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Tatchempharmpreparaty, JSC · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Stroke
• Acute Stroke
• Ischemic Stroke
• Cerebrovascular Disorders
• Physiological Effects of Drugs

Interventions

Type	Name	Description
DRUG	Dimephosphon®	1 g/ml, concentrate for solution for intravenous infusion
DRUG	Placebo	Placebo IV solution

Timeline

• Start date: 2025-09-06
• Primary completion: 2026-01-31
• Completion: 2026-04-30
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

6 sites across 1 country: Russia