Phase 3
N=150
Study of Efficacy and Safety of MEXIDOL® in Ischemic Stroke Therapy
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02793687 ↗Enrolled (actual)
150
Serious AEs
2.7%
Results posted
Feb 2025
Primary outcome: Primary: Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms — 1.098; 1.46 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mexidol (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Pharmasoft
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms |
1.098; 1.46 | — |
| SECONDARY Mean Score of the 15-item The National Institutes of Health Stroke Scale (NIHSS) at Visit 5 After Completion of the Course of Therapy for Both Arms |
1.689; 2.222 | — |
| SECONDARY Mean Score of the 10-item Barthel Index (BI) at Visit 5 After Completion of the Course of Therapy for Both Arms |
96.066; 93.571 | — |
| SECONDARY Mean Score of the 21-item Beck Depression Inventory (BDI) at Visit 5 After Completion of the Course of Therapy for Both Arms. |
2.213; 2.190 | — |
| SECONDARY Mean Score of on the EQ-5D-3L PRO Measure (VAS) at Visit 5 After Completion of the Course of Therapy for Both Arms. |
83.82; 78.175 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of long-term sequential therapy with Mexidol® in long-term sequential treatment of patients in the acute and early recovery periods of hemispheric ischemic stroke (IS). This is superiority trial that investigates whether Mexidol® better than placebo.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of first-ever hemispheric ischemic stroke (codes ICD-10: I63.0 - I63.9).
- Age 18-80 years
- The ability to understand the purpose of research, risks associated with the research intervention, obligations and consequences of research participation and their right of withdrawing consent any time during the study.
- The time from onset of a stroke 80 years.
- The National Institutes of Health Stroke Scale (NIHSS) score is 15 points.
- Hemorrhagic stroke confirmed with CT/MRI.
- Hemorrhagic transformation of ischemic stroke.
- Recurrent ischemic stroke.
- Parkinson's disease.
- Epilepsy.
- Demyelinating diseases of central nervous system.
- Hereditary and degenerative diseases of the central nervous system.
- Infectious diseases of central nervous system in medical history.
- Traumatic brain injury with severe neurocognitive impairment in medical history.
- Unstable angina pectoris.
- The participant had a heart attack within 3 months prior to enrollment.
- Heart failure class IV (NYHA).
- 2nd and 3rd-degree atrioventricular block.
- Systemic connective tissue disorders.
- Chronic obstructive pulmonary disease (stage III or IV).
- Acute surgical pathology
- Severe decompensated heart failure/liver disease/kidney disease (including acute or chronic kidney/hepatic failure).
- Medical history of oncology diseases, tuberculosis, immunodeficiency disorders, mental disorders or alcohol/drug addiction.
- The investigator's decision not to enroll participant due to any severe condition that can be issue of safety or treatment efficacy.
- Acute infectious diseases (influenza, SARS, etc.) within 4 weeks prior to enrollment.
- Evidence of lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Pregnancy or breastfeeding.
- Any reason (including mental or physical states) that can affect participant's capability to follow protocol procedures.
- The participant (or their relative) is affiliated with the clinical site or Sponsor company.
- Participation in another clinical trial within 3 months prior to enrollment.
- Evidence of hypersensitivity reactions or intolerance associated with ethylmethylhydroxypyridine, succinate drugs or Vitamin B6.
- Medical contraindications for Mexidol®.
- The written informed consent form (ICF) is not signed and personally dated by the participant or by an impartial witness.
Data sourced from ClinicalTrials.gov (NCT02793687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.