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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pharmasoft
- Enrollment
- 318
- Locations
- 14
- Primary Endpoint
- Mean Score of Montreal Cognitive Assessment (MoCA) at Visit 5 in Comparison With Reference Score at Visit 0
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
Arms & Interventions
Main (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
Intervention: Mexidol (Drug)
Control (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
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Mean Score of Montreal Cognitive Assessment (MoCA) at Visit 5 in Comparison With Reference Score at Visit 0
Time Frame: Day 75+2 (Visit 5) compared with the baseline level (Visit 0, 7 days before treatment)
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 Outcomes
- Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Physical Health)(Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment))
- Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Mental Health)(Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment))
- Changes in the Severity of Asthenia Assessed With the Multidimensional Fatigue Inventory (MFI-20)(Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment))
- Changes in the Anxiety Level According to the Beck Anxiety Inventory(Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment))
- Autonomic Changes According to the A.M.Wein's Questionnaire(Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment))
- Changes in Cognitive Impairment Assessed With Digit Symbol Substitution Test(Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment))
- Motor Changes Assessed With the Tinetti Test(Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment))
- Change in Global Illness Severity Assessed With the Clinical Global Impressions Scale at Visit 5 Compared to Baseline Measure(Day 75+2 (Visit 5))
- Changes in the Severity of Cognitive Impairment Assessed With the Montreal Cognitive Assessment Scale Between Visit 0 and Visits 2 and 4(Day 14 (Visit 2) and Day 44±2 (Visit 4) compared with the baseline level (Visit 0, 7 days before treatment))