At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 150 enrolled
Drug / intervention
Mexidol +1 moredrug
Likely dose
Mexidol 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Mexidol and Placebo for Ischemic Stroke. Completed, enrolled 150 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Stroke
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
Primary CompletionMay 2016
First PostedJun 2016
TodayJul 2026
First PostedJun 8, 2016
Enrollment StartMar 6, 2015
Primary CompletionMay 27, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.1 years ago
Interventions
Mexidoldrug
50 mg/ml IV solution, 125 mg tablet
Placeboother
Placebo IV solution, Placebo tablet