Study of Efficacy and Safety of MEXIDOL® in Ischemic Stroke Therapy

NCT02793687 | Completed Phase 3 Results

• 2 other identifiers: EPICA2013-08-11
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Ischemic Stroke

Keywords

Stroke; Ischemic Stroke; Neuroprotective Agents; Nootropic Agents; Antioxidants; Randomized Controlled Trials as Topic; Recovery of Function; Mexidol; Ethylmethylhydroxypyridine Succinate; Brain Ischemia; Acute Stroke; Acute Cerebrovascular Accident; Cerebral Stroke; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms

  The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 6 (dead) \[6 point scale: min value 0, max value 6, higher scores mean a worse outcome\].

  Visit 5 (67-71 Day).

Secondary Outcomes (4)

• 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

  Visit 5 (67-71 Day)

• Mean Score of the 10-item Barthel Index (BI) at Visit 5 After Completion of the Course of Therapy for Both Arms

  Time frame: Visit 5 (67-71 Day)

• Mean Score of the 21-item Beck Depression Inventory (BDI) at Visit 5 After Completion of the Course of Therapy for Both Arms.

  Visit 5 (67-71 Day)

• Mean Score of on the EQ-5D-3L PRO Measure (VAS) at Visit 5 After Completion of the Course of Therapy for Both Arms.

  Visit 5 (67-71 Day)

Study Arms (2)

Mexidol®

EXPERIMENTAL

Participants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.

Drug: Mexidol

Placebo

PLACEBO COMPARATOR

Participants received Mexidol Placebo matching Mexidol solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks.

Other: Placebo

Interventions

Mexidol DRUG

50 mg/ml IV solution, 125 mg tablet

Also known as: Ethylmethylhydroxypyridine Succinate

Mexidol®

Placebo OTHER

Placebo IV solution, Placebo tablet

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<72 hours.
• The Modified Rankin Scale (mRS) score ≥3.
• The National Institutes of Health Stroke Scale (NIHSS) score from 5 to 15 points.
• The Beck Depression Inventory (BDI) score \<19 points.
• The written informed consent form (ICF) is signed and personally dated by the participant or by an impartial witness (by a person who is independent of the trial and cannot be unduly influenced by the people involved with the trial and who attends the informed consent process).
• Negative pregnancy test for women of childbearing age.
• Willingness to use reliable methods of contraception, and/or abstinence, for the duration of therapeutic product exposure.

You may not qualify if:

• No evidence of clinical diagnosis of first-ever hemispheric ischemic stroke (codes ICD-10: I63.0 - I63.9).
• Age \<40 and \> 80 years.
• The National Institutes of Health Stroke Scale (NIHSS) score is \<5 or \>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).

Sponsors & Collaborators

• Pharmasoft: lead

Study Sites (11)

Tatarstan Republican Clinical Hospital

Kazan', 410064, Russia

Location

Interregional Clinical Diagnostic Center

Kazan', 420101, Russia

Location

Kazan Clinical Hospital № 7

Kazan', 420103, Russia

Location

Research Institute of Experimental and Clinical Medicine

Novosibirsk, 630117, Russia

Location

St. Petersburg Clinical Hospital № 26

Saint Petersburg, 196247, Russia

Location

St. Petersburg Clinical Hospital № 2

Saint Petersburg, 196354, Russia

Location

St. Petersburg "Nikolaevskaya" Hospital

Saint Petersburg, 198510, Russia

Location

Samara Regional Clinical Hospital n.a. V. D. Seredavin

Samara, 443095, Russia

Location

Samara Clinical Hospital № 1 n.a. N. I. Pirogov

Samara, 443096, Russia

Location

City Hospital № 40 of Kurortny District

Sestroretsk, 197706, Russia

Location

Vsevolozhsk Clinical Interdistrict Hospital

Vsevolozhsk, 188643, Russia

Location

Related Publications (2)

• Stakhovskaya LV, Shamalov NA, Khasanova DR, Melnikova EV, Agafiina AS, Golikov KV, Bogdanov EI, Yakupova AA, Roshkovskaya LV, Lukinykh LV, Lokshtanova TM, Poverennova IE, Shepankevich LA. [Results of a randomized double blind multicenter placebo-controlled, in parallel groups trial of the efficacy and safety of prolonged sequential therapy with mexidol in the acute and early recovery stages of hemispheric ischemic stroke (EPICA)]. Zh Nevrol Psikhiatr Im S S Korsakova. 2017;117(3. Vyp. 2):55-65. doi: 10.17116/jnevro20171173255-65. Russian.

  PMID: 28665371 RESULT

• Stakhovskaya LV, Mkhitaryan EA, Tkacheva ON, Ostroumova TM, Ostroumova OD. [Efficacy and safety of mexidol across age groups in the acute and early recovery stages of hemispheric ischemic stroke (results of additional sub-analysis of a randomized double blind multicenter placebo-controlled study, in parallel groups trial EPICA)]. Zh Nevrol Psikhiatr Im S S Korsakova. 2020;120(8. Vyp. 2):49-57. doi: 10.17116/jnevro202012008249. Russian.

  PMID: 33016677 RESULT

Related Links

• Results of a randomized double blind multicenter placebo-controlled, in parallel groups trial of the efficacy and safety of prolonged sequential therapy with mexidol in the acute and early recovery stages of hemispheric ischemic stroke (EPICA)
• Results of additional sub-analysis of a randomized double blind multicenter placebo-controlled study, in parallel groups trial EPICA

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Brain Ischemia

Interventions

emoxypine succinate; ethylmethylhydroxypyridine succinate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Meshcherskiy Y.E., Medical director
• Organization: Pharmasoft

meshcherskiy_y@pharmasoft.ru

+ 7 (495) 626-47- 55

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 8, 2016
• Study Start: March 6, 2015
• Primary Completion: May 27, 2016
• Study Completion: May 27, 2016
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2024-07

Locations

RU (11)