The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke

Study Overview
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Brief Summary
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The study investigated the clinical efficacy and safety of a 10-day course of therapy with daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2 parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment. The clinical observation period for each patient will be 3 months and will include six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Cerebrolysin
* Drug: 0.9% Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 85 years Focal neurological deficit Clinical diagnosis of acute hemispheric ischemic stroke CT or MRI results compatible with clinical diagnosis of acute hemispheric stroke NIH Stroke Scale Score between 6 and 22, both inclusive Functionally independent prior to stroke with a pre-stroke Rankin Score of 0 or 1 Randomization and first treatment with the trial medication within 12h after stroke onset Informed consent given by the patient and/or the patient's legally acceptable representative Exclusion Criteria: Evidence on CT/MRI of acute or chronic intracerebral hemorrhage, SAH, AVM, cerebral aneurysm, or neoplasm Signs of herniation, increased intracranial pressure or likely etiology other than brain ischemia at baseline CT scan Patients with a substantial decrease of consciousness or alertness at the time of randomization, defined as score of 2 or more one of the NIH Stroke Scale questions 1a. Neurological signs and symptoms that improve rapidly during screening and are likely to resolve completely within 24h Severe coexisting systemic disease that significantly limits life expectancy Systolic blood pressure over 220 mmHg or diastolic blood pressure over 120 mmHg on repeated measurement (interval of 30 min) prior to study entry Severe congestive heart failure or presentation with acute myocardial infarction at study entry Epilepsy or epileptic seizures at onset of stroke Pre-existing disorders or conditions that would impair interpretation of neurological assessment (eg. severe dementia, severe psychiatric illnesses, etc). Concomitant treatment with other neuroprotective or nootropic drugs (e.g. piracetam, citicoline, investigational neuroprotective substances) Patients which cannot tolerate or have contraindication to aspirin or Cerebrolysin treatment Concomitant treatment with substances that have a dilative effect on blood vessels like naftidrofuryl, cinnarizine, flunarizine or nimodipine Pregnancy and lactation period; for women with child-bearing potential a negative pregnancy test is required Participation in a clinical trial with an investigational drug in the past 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerebrolysin<br> | Drug: Cerebrolysin<br>* 30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.<br>|
| Placebo Comparator: 0.9% Saline Solution<br> | Drug: 0.9% Saline Solution<br>* 30 ml will be given once daily by intravenous infusion for 10 consecutive days.<br>* Other names: NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale |  | 90 days after start of treatment | 
| Barthel Index |  | 90 days after start of treatment | 
| NIH Stroke Scale |  | 90 days after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 |  | 90 days after start of treatment | 
| Overall mortality |  | Throughout the study |