Status:
COMPLETED
The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
Lead Sponsor:
Ever Neuro Pharma GmbH
Collaborating Sponsors:
Excel PharmaStudies, Inc.
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Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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 acu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
1071 Patients enrolled
Trial Details
Trial ID
NCT00868283
Start Date
September 1 2006
End Date
February 1 2011
Last Update
December 15 2023
Active Locations (49)
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1
Mudanjiang 1st people Hospital
Mudanjiang, Heilongjiang, China
2
Mudanjiang 2nd people Hospital
Mudanjiang, Heilongjiang, China
3
Anhui Shengli Hospital
Anhui, China
4
Anshan hospital
Anshan, China