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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00868283
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : July 7, 2011
Excel PharmaStudies, Inc.
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Information provided by:
Ever Neuro Pharma GmbH

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 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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Cerebrolysin Drug: 0.9% Saline Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1071 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
Study Start Date : September 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: Cerebrolysin Drug: Cerebrolysin
30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.

Placebo Comparator: 0.9% Saline Solution Drug: 0.9% Saline Solution
30 ml will be given once daily by intravenous infusion for 10 consecutive days.
Other Name: NaCl

Primary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 90 days after start of treatment ]
  2. Barthel Index [ Time Frame: 90 days after start of treatment ]
  3. NIH Stroke Scale [ Time Frame: 90 days after start of treatment ]

Secondary Outcome Measures :
  1. SF-12 [ Time Frame: 90 days after start of treatment ]
  2. Overall mortality [ Time Frame: Throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00868283

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Sponsors and Collaborators
Ever Neuro Pharma GmbH
Excel PharmaStudies, Inc.
idv Datenanalyse und Versuchsplanung
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Study Director: Philipp Novak, PhD EVER Neuro Pharma
Principal Investigator: Zhen Hong, MD Huashan Hospital, affiliated Fudan University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Philipp Novak, EVER Neuro Pharma Identifier: NCT00868283     History of Changes
Other Study ID Numbers: EBE-CN-050823
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
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Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents