Safety and Efficacy of Sequential Treatment with Mexidol® in Patients with Chronic Cerebral Ischemia
- Registration Number
- NCT06834490
- Lead Sponsor
- Pharmasoft
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
Not provided
- Inclusion by mistake (overlooked inclusion or non-inclusion criteria)
- Investigator's or Sponsor's decision to exclude a participant from the study due to a clinically significant protocol deviation/violation.
- Serious adverse events or adverse events that do not meet the criteria for seriousness but may, in the investigator's opinion, be detrimental to the health or well-being of a participant if they continue participation in the study.
- Any adverse event (which may be unrelated to the investigational drug) requiring observations, procedures, and/or medications not approved by the clinical trial protocol.
- Participant's refusal to continue participation in the study or their lack of discipline
- Allergic reaction to the investigational drug that requires cancelling the treatment
- Participant's desire to terminate their participation early for any reason.
- Loss of contact with the patient followed by failure to attend the visit.
- The need to take therapies prohibited by this protocol: nootropic drugs, ethylmethylhydroxypyridine succinate, trimetazidine or meldonium, drugs affecting the function of the autonomic nervous system and other drugs that may, in the investigator's opinion, distort the study results.
- Pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Main (Mexidol) Mexidol Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days Control (Placebo) Placebo Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
- Primary Outcome Measures
Name Time Method Mean Score of Montreal Cognitive Assessment (MoCA) at Visit 5 in comparison with reference score at Visit 0 up to 83 days The Montreal Cognitive Assessment (MoCA) is used to measure the degree of cognitive impairment in patients with CCI. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. Higher score than shown at Visit 0 is expected after treatment.
- Secondary Outcome Measures
Name Time Method Changes in the severity of cognitive impairment assessed with the Montreal Cognitive Assessment scale between Visit 0 and Visits 2 and 4 up to 83 days The Montreal Cognitive Assessment (MoCA) is used to measure the changes in the severity of cognitive impairment at Visits 2 and 4 in comparison to Visit 0. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. Higher score than shown at Visit 0 is expected.
Changes in the severity of asthenia assessed with the Multidimensional Fatigue Inventory (MFI-20) up to 83 days The Multidimensional Fatigue Inventory (MFI-20) is used between Visit 1 and Visits 2, 4, 5. MFI-20 is a 20-item self-administered questionnaire designed to measure fatigue in five four-item subscales: General fatigue, Physical fatigue, Reduced activity, Reduced motivation and Mental fatigue. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue.
Changes in patients' quality of life assessed with SF-36 questionnaire up to 83 days The SF-36 questionnaire is used between Visit 1 and Visits 2, 4, 5. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Autonomic changes according to the A.M.Wein's questionnaire up to 83 days The A.M.Wein's questionnaire is used between Visit 1 and Visit 2, 4, 5. It includes 11 main signs of autonomic disorders. Each autonomic symptom is assessed using scores from 7 to 3. The total sum of the scores reflects the degree of the severity of vegetative dystonia.
Changes in the anxiety level according to the Beck Anxiety Inventory up to 83 days The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Changes in global illness severity assessed with the Clinical Global Impressions Scale up to 83 days The Clinical Global Impressions (CGI) Scale is used between Visit 1 and Visits 2, 5. The CGI Scale is a standardized assessment tool used to rate the severity of illness, change over time, and efficacy of medication. It consists of 3 subscales. The first one, Severity of Illness, which is often used both before and after treatment, is a 7-point scale that rates the severity of the patient's mental illness at the time of assessment as: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. The second subscale, Clinical Global Impression-Improvement (CGI-I), is also a 7-point scale that assesses how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention, and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Changes in cognitive impairment assessed with Digit Symbol Substitution Test up to 83 days The Digit Symbol Substitution Test is used between Visit 1 and Visits 2, 4, 5. The DSST is used to measure attention, processing speed and executive function.
It is a pencil and paper test of psychomotor performance in which the subject is given a key grid of numbers and matching symbols and a test section with numbers and empty boxes. The test consists of filling as many empty boxes as possible with a symbol matching each number. The score is the number of correct number-symbol matches achieved in 90 s.Motor changes assessed with the Tinetti test up to 83 days The Tinetti test is used between Visit 1 and Visits 2, 4, 5. The Tinetti test is a clinical test for the assessment of balance and gait. It has a gait score and a balance score using a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
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Trial Locations
- Locations (14)
Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh
🇷🇺Voronezh, Russian Federation
OOO "Centre for Evidence-Based Medicine"
🇷🇺Yaroslavl, Russian Federation
State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"
🇷🇺Yaroslavl, Russian Federation
Centre for Neurology and Neurorehabilitation n.a. N. M. Madzhido, OOO "Neyromed Servis"
🇺🇿Tashkent, Uzbekistan
Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1"
🇷🇺Chelyabinsk, Russian Federation
State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
🇷🇺Ekaterinburg, Russian Federation
Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"
🇷🇺Ivanovo, Russian Federation
Federal State Budget Educational Institution of Higher Education "Kazan State Medical University"
🇷🇺Kazan, Russian Federation
Federal State Budget Research Institution "Research Center of Neurology"
🇷🇺Moscow, Russian Federation
Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"
🇷🇺Moscow, Russian Federation
State Budget Healthcare Institution of the Novosibirsk Region "City Hospital № 34"
🇷🇺Novosibirsk, Russian Federation
Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"
🇷🇺Novosibirsk, Russian Federation
Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"
🇷🇺Saint Petersburg, Russian Federation
City Hospital No.40 of the Kurortny District
🇷🇺Sestroretsk, Russian Federation