Trial · NCT02793687
Study of Efficacy and Safety of MEXIDOL® in Ischemic Stroke Therapy
NCT02793687, Phase 3, Completed, Pharmasoft; results first posted 2025-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of MEXIDOL® in Ischemic Stroke Therapy. Trials, record NCT02793687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02793687
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of MEXIDOL® in Ischemic Stroke Therapy
- NCT number
- NCT02793687
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Pharmasoft
- Conditions
- Ischemic Stroke
- Interventions
- Mexidol, Placebo
- First posted
- 2016-06-08
- Last updated
- 2025-02-24
- Results first posted
- 2025-02-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms | 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) \[6 point scale: min value 0, max value 6, higher scores mean a worse outcome\]. |
| 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 | Visit 5 (67-71 Day) | 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). |
| Secondary | 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) | 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. |
| Secondary | 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) | 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). |
| 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. | Visit 5 (67-71 Day) | 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms | Visit 5 (67-71 Day). | Per Protocol Population (all participant assigned to Mexidol or Placebo) for calculating the mean score of the 6-point Modified Rankin Scale (mRS) at Visit 5 after completion of the course of therapy for both arms. | score on a scale | MEAN |
| 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 | Visit 5 (67-71 Day) | Per Protocol Population (all participant assigned to Mexidol or Placebo) for calculating the 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. | score on a scale | MEAN |
| SECONDARY | 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) | Per Protocol Population (all participant assigned to Mexidol or Placebo) for calculating the mean score of the 10-item Barthel Index (BI) at Visit 5 after completion of the course of therapy for both arms. | score on a scale | MEAN |
| SECONDARY | 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) | Per Protocol Population (all participant assigned to Mexidol or Placebo) for calculating the mean score of the 21-item Beck Depression Inventory (BDI) at Visit 5 after completion of the course of therapy for both arms. | score on a scale | MEAN |
| 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. | Visit 5 (67-71 Day) | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms | Mexidol® | 1.098 | Standard Deviation 0.768 | score on a scale | |
| Mean Score of the 6-point Modified Rankin Scale (mRS) at Visit 5 After Completion of the Course of Therapy for Both Arms | Placebo | 1.46 | Standard Deviation 0.947 | score on a scale | |
| 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 | Mexidol® | 1.689 | Standard Deviation 1.397 | score on a scale | |
| 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 | Placebo (Group 2) | 2.222 | Standard Deviation 1.442 | score on a scale | |
| Mean Score of the 10-item Barthel Index (BI) at Visit 5 After Completion of the Course of Therapy for Both Arms | Mexidol® | 96.066 | Standard Deviation 7.806 | score on a scale | |
| Mean Score of the 10-item Barthel Index (BI) at Visit 5 After Completion of the Course of Therapy for Both Arms | Placebo | 93.571 | Standard Deviation 12.229 | score on a scale | |
| Mean Score of the 21-item Beck Depression Inventory (BDI) at Visit 5 After Completion of the Course of Therapy for Both Arms. | Mexidol® | 2.213 | Standard Deviation 2.491 | score on a scale | |
| Mean Score of the 21-item Beck Depression Inventory (BDI) at Visit 5 After Completion of the Course of Therapy for Both Arms. | Placebo | 2.190 | Standard Deviation 2.693 | score on a scale | |
| Mean Score of on the EQ-5D-3L PRO Measure (VAS) at Visit 5 After Completion of the Course of Therapy for Both Arms. | Mexidol® | 83.82 | Standard Deviation 15.499 | score on a scale | |
| Mean Score of on the EQ-5D-3L PRO Measure (VAS) at Visit 5 After Completion of the Course of Therapy for Both Arms. | Placebo | 78.175 | Standard Deviation 17.52 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mexidol® | 75 | |
| Overall Study | STARTED | Placebo | 75 | |
| Overall Study | COMPLETED | Mexidol® | 61 | |
| Overall Study | COMPLETED | Placebo | 63 | |
| Overall Study | NOT COMPLETED | Mexidol® | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gout | Metabolism and nutrition disorders | Mexidol® | 1 | 75 | 1 |
| other | Gout | Metabolism and nutrition disorders | Placebo | 2 | 75 | 2 |
| other | Dyslipidaemia | Metabolism and nutrition disorders | Mexidol® | 1 | 75 | 1 |
| other | Dyslipidaemia | Metabolism and nutrition disorders | Placebo | 0 | 75 | 0 |
| other | Hepatic enzyme increased | Metabolism and nutrition disorders | Mexidol® | 1 | 75 | 1 |
| other | Hepatic enzyme increased | Metabolism and nutrition disorders | Placebo | 0 | 75 | 0 |
| other | Type 2 diabetes mellitus | Metabolism and nutrition disorders | Mexidol® | 0 | 75 | 0 |
| other | Type 2 diabetes mellitus | Metabolism and nutrition disorders | Placebo | 1 | 75 | 1 |
| other | Depressed level of consciousness | Nervous system disorders | Mexidol® | 1 | 75 | 1 |
| other | Depressed level of consciousness | Nervous system disorders | Placebo | 0 | 75 | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mexidol® | 0 | 75 |
| Total, all-cause mortality | Placebo | 0 | 75 |
| Total, other adverse events | Mexidol® | 21 | 75 |
| Total, other adverse events | Placebo | 16 | 75 |
| Total, serious adverse events | Mexidol® | 1 | 75 |
| Total, serious adverse events | Placebo | 3 | 75 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mexidol® vs Placebo: deaths from any cause | Trial comparisons |
| Mexidol® vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02793687
GET https://conductscience.org/api/trials/v1/NCT02793687/events?page=2