Ischemic StrokePhase 3EPICANCT02793687
Study of Efficacy and Safety of MEXIDOL® in Ischemic Stroke Therapy
A Phase 3 study testing Mexidol in people with Ischemic Stroke, run by Pharmasoft at 11 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mexidol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 11 sitesRussia
- Study dates
- 6 Mar 2015to 27 May 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 31Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
Tatarstan Republican Clinical Hospital
Kazan', 410064
Interregional Clinical Diagnostic Center
Kazan', 420101
Kazan Clinical Hospital № 7
Kazan', 420103
Research Institute of Experimental and Clinical Medicine
Novosibirsk, 630117
St. Petersburg Clinical Hospital № 26
Saint Petersburg, 196247
St. Petersburg Clinical Hospital № 2
Saint Petersburg, 196354
St. Petersburg "Nikolaevskaya" Hospital
Saint Petersburg, 198510
Samara Regional Clinical Hospital n.a. V. D. Seredavin
Samara, 443095
Samara Clinical Hospital № 1 n.a. N. I. Pirogov
Samara, 443096
City Hospital № 40 of Kurortny District
Sestroretsk, 197706
Vsevolozhsk Clinical Interdistrict Hospital
Vsevolozhsk, 188643
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety of Mexidol® in Long-term Sequential Treatment of Patients in the Acute and Early Recovery Periods of Hemispheric Ischemic Stroke (EPICA)
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.
Read the detailed description
In the course of a clinical study involving patients, the efficacy and safety of prolonged sequential therapy with Mexidol® (solution for intravenous and intramuscular administration / coated tablets) were evaluated compared to placebo in patients with hemispheric ischemic stroke during the acute and early recovery periods. The use of Mexidol® (solution for intravenous and intramuscular administration / coated tablets) and placebo (solution for intravenous and intramuscular administration / coated tablets) was conducted against the background of standard baseline therapy.
Throughout the study, both the investigational drug Mexidol® and the placebo, used alongside baseline therapy, were tolerated satisfactorily. In this clinical study, 37 cases of adverse events (AEs) not meeting the criteria for severity were recorded in 28 patients, along with 4 AEs that were categorized as serious adverse events (SAEs) in 4 patients. Most of the registered AEs required appropriate corrective therapy but did not necessitate other medical interventions and resolved by the end of the patient's participation in the study. According to the researchers, in the majority of recorded AEs, the relationship with the investigational drugs was determined to be absent (no relationship).
When comparing the frequency of registration of both individual AEs and SAEs, no statistically significant differences (p < 0.05) were found in the frequency of AEs/SAEs in patients after taking the investigational drug (Mexidol®) and the comparison drug (placebo). According to the conducted clinical study, the safety profile of Mexidol® remained unchanged and favorable. No new safety signals were recorded during the course of the study.
The primary endpoint is the results of testing using the modified Rankin Scale (mRS) at the end of the therapy course (in both the investigational and control groups). In the overall population of patients included in the efficacy analysis, positive dynamics were observed in both the Mexidol® group and the placebo group (p < 0.001): a decrease in the mean scores on the scale throughout the study; a statistically significant difference was also identified between the mean scores on the mRS at visit 5 compared to baseline values (visit 1) in both groups. Additionally, at visit 5, a statistically significant difference was observed between the treatment groups (p = 0.04) regarding the total scores on the modified Rankin Scale: the average score for the Mexidol® group was 1.098 points, while for the placebo group, it was 1.46 points. No statistically significant differences between the groups were found at other visits. The assessment of the change in mRS score from baseline (visit 1) to the end of therapy (visit 5) showed statistically significant differences (p = 0.04) between the treatment groups: in the Mexidol® group, the value was 1.098; in the placebo group, it was 1.460.
Thus, Mexidol® demonstrated greater efficacy compared to placebo when used alongside baseline therapy in patients with hemispheric ischemic stroke during the acute and early recovery period based on the primary efficacy criterion, which is the results of testing using the modified Rankin Scale (mRS) at the end of the therapy course.
Furthermore, the study demonstrated the efficacy of Mexidol® therapy concerning several secondary efficacy endpoints. Mexidol® showed greater efficacy in treating hemispheric ischemic stroke compared to placebo when using the specialized scale for this condition-the NIHSS (National Institutes of Health Stroke Scale). In testing using the Beck Depression Inventory (BDI), the efficacy of Mexidol® regarding cognitive disorders in patients who suffered strokes with concurrent diabetes was also identified.
- Conditions
- Ischemic Stroke
- Being tested
- Mexidol, Placebo
- 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
- Medical subject headings
- Ischemic Stroke, Stroke, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MexidolDrug
Also called Ethylmethylhydroxypyridine Succinate
50 mg/ml IV solution, 125 mg tablet
PlaceboOther
Placebo IV solution, Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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
The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The individual scores from each item are summed in order to calculate a patient's total NIHSS score.
The maximum possible score is 42 (severe stroke), with the minimum score being a 0 (no stroke symptoms).
Measured: 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
The Barthel Index (BI) is a prominent measure that assesses an individual's ability to perform activities of daily living (ADL) independently, reflecting their mobility and functional capacity. BI evaluates ten specific activities: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation, and stair climbing. Each activity is weighted based on the level of assistance required, with scores assigned as follows: 10 (independent), 5 (some assistance), and 0 (dependent).
The BI's scoring system favors mobility and continence, resulting in a total score ranging from 0 to 100, where a higher score indicates greater functional independence. The index is widely utilized for assessing functional disability, particularly in rehabilitation settings for stroke patients and individuals with neuromuscular or musculoskeletal disorders, as well as in oncology care.
Measured: 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.
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Each item is scored 0 to 3 points for a total score range of 0 to 63. This range includes interpretation from 0-9 points (as normal condition) to over 30 points (as severe depression).
Measured: 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.
EQ-5D-3L is a concise, generic patient-reported outcome (PRO) measure of health consisting of five dimensions of health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (VAS). In the study version was used EQ-5D-3L that contains 3 severity levels for each dimension. The EQ VAS records the participants's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' (maximum indicated as 100 scores on VAS) and 'The worst health you can imagine' (minimum indicated as 0 on VAS).
Measured: Visit 5 (67-71 Day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start6 Mar 2015
- Primary completion27 May 2016
- Study completion27 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmasoft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793687
- Sponsor's protocol ID
- EPICA
- Other IDs
- 2013-08-11
- Acronym
- EPICA
- Status last verified
- Jul 2024
- First submitted
- 31 May 2016
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28665371Stakhovskaya 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.
PubMed 33016677
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety of Mexidol® in Long-term Sequential Treatment of Patients in the Acute and Early Recovery Periods of Hemispheric Ischemic Stroke (EPICA)
- ClinicalTrials.gov ID
- NCT02793687
- Acronym / sponsor ID
- EPICA / EPICA
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Ischemic Stroke, Neuroprotective Agents, Nootropic Agents, Antioxidants, Randomized Controlled Trials as Topic, Recovery of Function, Mexidol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- PharmasoftIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- 27 May 2016 (actual)
- Study completion
- 27 May 2016 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the course of a clinical study involving patients, the efficacy and safety of prolonged sequential therapy with Mexidol® (solution for intravenous and intramuscular administration / coated tablets) were evaluated compared to placebo in patients with hemispheric ischemic stroke during the acute and early recovery periods. The use of Mexidol® (solution for intravenous and intramuscular administration / coated tablets) and placebo (solution for intravenous and intramuscular administration / coated tablets) was conducted against the background of standard baseline therapy.
Throughout the study, both the investigational drug Mexidol® and the placebo, used alongside baseline therapy, were tolerated satisfactorily. In this clinical study, 37 cases of adverse events (AEs) not meeting the criteria for severity were recorded in 28 patients, along with 4 AEs that were categorized as serious adverse events (SAEs) in 4 patients. Most of the registered AEs required appropriate corrective therapy but did not necessitate other medical interventions and resolved by the end of the patient's participation in the study. According to the researchers, in the majority of recorded AEs, the relationship with the investigational drugs was determined to be absent (no relationship).
When comparing the frequency of registration of both individual AEs and SAEs, no statistically significant differences (p < 0.05) were found in the frequency of AEs/SAEs in patients after taking the investigational drug (Mexidol®) and the comparison drug (placebo). According to the conducted clinical study, the safety profile of Mexidol® remained unchanged and favorable. No new safety signals were recorded during the course of the study.
The primary endpoint is the results of testing using the modified Rankin Scale (mRS) at the end of the therapy course (in both the investigational and control groups). In the overall population of patients included in the efficacy analysis, positive dynamics were observed in both the Mexidol® group and the placebo group (p < 0.001): a decrease in the mean scores on the scale throughout the study; a statistically significant difference was also identified between the mean scores on the mRS at visit 5 compared to baseline values (visit 1) in both groups. Additionally, at visit 5, a statistically significant difference was observed between the treatment groups (p = 0.04) regarding the total scores on the modified Rankin Scale: the average score for the Mexidol® group was 1.098 points, while for the placebo group, it was 1.46 points. No statistically significant differences between the groups were found at other visits. The assessment of the change in mRS score from baseline (visit 1) to the end of therapy (visit 5) showed statistically significant differences (p = 0.04) between the treatment groups: in the Mexidol® group, the value was 1.098; in the placebo group, it was 1.460.
Thus, Mexidol® demonstrated greater efficacy compared to placebo when used alongside baseline therapy in patients with hemispheric ischemic stroke during the acute and early recovery period based on the primary efficacy criterion, which is the results of testing using the modified Rankin Scale (mRS) at the end of the therapy course.
Furthermore, the study demonstrated the efficacy of Mexidol® therapy concerning several secondary efficacy endpoints. Mexidol® showed greater efficacy in treating hemispheric ischemic stroke compared to placebo when using the specialized scale for this condition-the NIHSS (National Institutes of Health Stroke Scale). In testing using the Beck Depression Inventory (BDI), the efficacy of Mexidol® regarding cognitive disorders in patients who suffered strokes with concurrent diabetes was also identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mexidol® | Experimental | Drug: MexidolParticipants received Mexidol® solution IV 500 mg daily for 10 days, then Mexidol 125 mg orally 1 tablet 3 times a day for 8 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MexidolAlso: Ethylmethylhydroxypyridine Succinate50 mg/ml IV solution, 125 mg tablet | Drug | Mexidol® |
| PlaceboPlacebo IV solution, Placebo tablet | Other | Placebo |
Primary outcome
Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms
Time frame: Visit 5 (67-71 Day).
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].
4 secondary outcomes
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
Time frame: 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: 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.
Time frame: 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.
Time frame: Visit 5 (67-71 Day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28665371Stakhovskaya 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.
- Results publication: PubMed 33016677Stakhovskaya 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.
- 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)Link provided by the sponsor.
- Results of additional sub-analysis of a randomized double blind multicenter placebo-controlled study, in parallel groups trial EPICALink provided by the sponsor.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mexidol in people with Ischemic Stroke, run by Pharmasoft at 11 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms (time frame: Visit 5 (67-71 Day).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.