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

Summary

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

Conditions

• Chronic Cerebral Ischemia

Interventions

DRUG

Mexidol

50 mg/ml IV solution, 250 mg tablets

DRUG

Placebo

Placebo IV solution, Placebo tablets

Sponsors & Collaborators

• Pharmasoft

  lead INDUSTRY

Principal Investigators

• Alina S. Agafina, MD, Cand.Med.Sci · Saint Petersburg State Budget Healthcare Institution "City Hospital No.40 of the Kurortny District"

• Elena V. Vostrikova, MD, Cand.Med.Sci · State Budget Healthcare Institution of the Nivisibirsk Region "City Hospital No.34"

• Andrey M. Alasheev, MD, Dr.Med.Sci · State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"

• Marine M. Tanashyan, Prof., Dr.Med.Sci · Federal State Budget Research Institution "Research Center of Neurology"

• Min G. Omelyanenko, MD, Dr.Med.Sci · Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"

• Stanislav O. Pozdnyakov, MD, Cand.Med.Sci · OOO "Centre for Evidence-Based Medicine"

• Aleksandr Y. Malygin, MD, Dr.Med.Sci · State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"

• Aida A. Yakupova, MD, Cand.Med.Sci · Federal State Budget Educational Institution of Higher Education "Kazan State Meical University"

• Igor V. Litvinenko, Prof., Dr.Med.Sci · Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"

• Irina G. Lukashevich, MD · Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1"

• Olga A. Sinitsyna, MD, Cand.Med.Sci · State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"

• Larisa A. Shchepankevich, MD, Dr.Med.Sci · Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"

• Galina A. Batishcheva, Prof., Dr.Med.Sci · Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh

• Olga D. Ostroumova, Prof., Dr.Med.Sci · Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"

• Yokutkhon N. Madzhidova, Prof., Dr.Med.Sci · Centre for Neurology and Neurorehabilitation n.a. N.M.Madzhido, OOO "Neyromed Servis"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-05

Primary Completion

2020-12-08

Completion

2020-12-08

Countries

• Russia
• Uzbekistan

Study Locations