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

Ever Neuro Pharma

Status and phase

Completed

Phase 4

Conditions

Ischemic Stroke

Treatments

Drug: Cerebrolysin

Drug: 0.9% Saline Solution

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00868283

EBE-CN-050823

Details and patient eligibility

About

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.

Enrollment

1,071 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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