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Study of Efficacy and Safety of MEXIDOL®

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ClinicalTrials.gov Identifier: NCT02793687
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Pharmasoft

Brief Summary:
A multicenter, prospective, randomized, double-blind, placebo-controlled, parallel group study in patients with stroke

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: MEXIDOL® (ethylmethylhydroxypyridine succinate) Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety of the Drug MEXIDOL® for a Long Sequence of Therapy in Patients With Hemispheric Ischemic Stroke in the Acute and Early Recovery Period
Study Start Date : October 2014
Actual Primary Completion Date : May 2016

Arm Intervention/treatment
Experimental: Mexidol

Sequential therapy with MEXIDOL® as follows: MEXIDOL® (i.v. solution) - 500 mg / day. for 10 days, followed by application MEXIDOL® 1 tablet of 125 mg three times a day (daily dose 375 mg) for 8 weeks.

The use of the study drug is held with basic therapy.

Drug: MEXIDOL® (ethylmethylhydroxypyridine succinate)
Placebo Comparator: Placebo

Sequential therapy as follows: Placebo (i.v. solution) for 10 days followed by placebo 1 tablet three times a day for 8 weeks.

The use of a placebo is held with basic therapy.

Other: Placebo



Primary Outcome Measures :
  1. modified Rankin Scale [ Time Frame: 5 times during 67-71 days of the treatment ]

Secondary Outcome Measures :
  1. The National Institutes of Health Stroke Scale [ Time Frame: 5 times during 67-71 days of the treatment ]
  2. Barthel Index [ Time Frame: 5 times during 67-71 days of the treatment ]
  3. Beck Depression Inventory [ Time Frame: 5 times during 67-71 days of the treatment ]
  4. EuroQoL Quality of Life Scale [ Time Frame: 5 times during 67-71 days of the treatment ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis: hemispheric ischemic stroke (codes ICD-10: I63.0 - I63.9), primary.
  2. Patients of both sexes, from 40 to 80 years.
  3. Patients who are able to understand the purpose of this study and observe the requirements of the Protocol;
  4. The time from onset of stroke - not more than 72 hours.
  5. Based on the Rankin Scale score of 3 points or more at the time of enrollment.
  6. Evaluation of NIHSS scale from 5 to 15 points.
  7. Based on the depression scale Beck <19 points
  8. Have personally signed and dated by the patient (or otherwise disinterested witness who is not a member of the research team and is not in direct subordinate to the principal investigator, in the absence of physical possibility of signing the patient) informed consent form.
  9. Have a negative pregnancy test for women of childbearing age.
  10. Consent to use adequate contraception female patients and / or willingness to use contraception female partners of male patients or abstinence from sexual activity for the period of the study.

Exclusion Criteria:

  1. Lack of diagnosis: hemispheric ischemic stroke (codes ICD-10: I63.0 - I63.9), primary.
  2. Age <40 and> 80 years.
  3. Assessment of the scale NIHSS <5 or> 15 points
  4. Hemorrhagic stroke (confirmed with imaging techniques (CT or MRI).
  5. Hemorrhagic infarction (ischemic stroke with hemorrhagic impregnation).
  6. Repeated ischemic stroke.
  7. Parkinson's disease.
  8. Epilepsy.
  9. Demyelinating disease of the nervous system.
  10. hereditary degenerative diseases of the CNS.
  11. The presence of CNS infectious diseases in history.
  12. Traumatic brain injury with severe neurological symptoms and cognitive disorders (including history).
  13. Unstable angina pectoris.
  14. Myocardial infarction, prescription of less than 3 months.
  15. Chronic heart failure functional class IV according to the classification of the New York Heart Association (NYHA).
  16. atrioventricular block degree II-III.
  17. Systemic connective tissue diseases.
  18. Chronic obstructive pulmonary stage III-IV disease.
  19. Acute surgical pathology.
  20. Heavy, decompensated heart disease, liver, kidney, acute / chronic renal / hepatic failure.
  21. A history of cancer, immunosuppressive conditions, tuberculosis, drug or alcohol addiction, mental illness.
  22. A history of any material, according to a research physician, state, prevents the inclusion in the study.
  23. Acute infectious diseases (influenza, SARS, etc.) In less than 4 weeks before the start of the study.
  24. Availability of information on lactose intolerance / congenital galactose intolerance; Lapp lactase deficiency or glucose-galactose syndrome malabsorption.
  25. Pregnancy, lactation.
  26. Mental, physical or other reasons that do not allow to adequately assess their behavior and comply with the terms of the protocol correctly.
  27. Patients who are employees of the research center, the sponsoring company, as well as their family members.
  28. Participation in a clinical trial of drugs in less than 3 months prior to the study.
  29. Any other conditions and circumstances make it difficult, according to the researcher, participated in the study.
  30. Individual intolerance emoxypine, as well as preparations containing a salt of succinic acid and vitamin B6 in history.
  31. The presence of any contraindications to the use of the drug MEXIDOL®
  32. No personally signed and dated by the patient (or otherwise disinterested witness in the absence of physical possibility of signing the patient) informed consent form.

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Responsible Party: Pharmasoft
ClinicalTrials.gov Identifier: NCT02793687     History of Changes
Other Study ID Numbers: 2013-08-11
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Emoxypine succinate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Psychotropic Drugs