Study of Efficacy and Safety of MEXIDOL®

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793687
• Other study ID #: 2013-08-11
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2016
• Last updated: June 3, 2016
• Start date: October 2014

Study information

• Verified date: June 2016
• Source: Pharmasoft
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: MoH of Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Drug:
• MEXIDOL® (ethylmethylhydroxypyridine succinate)

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmasoft

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale		5 times during 67-71 days of the treatment	No
Secondary	The National Institutes of Health Stroke Scale		5 times during 67-71 days of the treatment	No
Secondary	Barthel Index		5 times during 67-71 days of the treatment	No
Secondary	Beck Depression Inventory		5 times during 67-71 days of the treatment	No
Secondary	EuroQoL Quality of Life Scale		5 times during 67-71 days of the treatment	No