NCT06834490

Safety and Efficacy of Sequential Therapy With Mexidol® in Patients With Chronic Cerebral Ischemia

International Multicentre Randomized, Double-blind, Placebo-controlled Adaptive Design Clinical Trial to Evaluate the Safety and Efficacy of Sequential Therapy With Mexidol® Solution for Intravenous and Intramuscular Administration, 50 mg/ml (RPC PHARMASOFT LLC, Russia) and Mexidol® FORTE 250 Film-coated Tablets, 250 mg (RPC PHARMASOFT LLC, Russia) in Patients With Chronic Cerebral Ischemia (MEMO)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Pharmasoft · Industry
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety and efficacy of sequential treatment with Mexidol® in patients with chronic cerebral ischemia (CCI).

Detailed description

Chronic cerebral ischemia (CCI) is a cerebral vascular pathology caused by slow progressive diffuse disruption of blood flow to the brain with gradually increasing defects in its functioning. The activation of lipid peroxidation with the release of large amounts of active oxygen radicals plays the key role in the pathogenesis of ischemic disorders, which leads to the development of oxidative stress. However, traditional drug therapy, which is aimed at improving blood flow to the brain, is mainly based on drugs with psychostimulant component, and does not always prevent the increase of oxidative damage to the patients' body. That is why it is necessary to search for drugs that would correct these processes selectively. Mexidol contains ethylmethylhydroxypyridine succinate as an active substance and may be the drug of choice for the treatment of CCI patients.

Conditions

• Chronic Cerebral Ischemia

Interventions

Type	Name	Description
DRUG	Mexidol	50 mg/ml IV solution, 250 mg tablets
DRUG	Placebo	Placebo IV solution, Placebo tablets

Timeline

• Start date: 2019-11-05
• Primary completion: 2020-12-08
• Completion: 2020-12-08
• First posted: 2025-02-19
• Last updated: 2025-10-06
• Results posted: 2025-10-06

Locations

14 sites across 2 countries: Russia, Uzbekistan