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

This study has been completed.
Sponsor:
Collaborators:
Excel PharmaStudies, Inc.
idv Datenanalyse und Versuchsplanung
Information provided by:
Ever Neuro Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00868283
First received: March 23, 2009
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Ischemic Stroke
Drug: Cerebrolysin
Drug: 0.9% Saline Solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ever Neuro Pharma GmbH:

Primary Outcome Measures:
  • Modified Rankin Scale [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
  • NIH Stroke Scale [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-12 [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
  • Overall mortality [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 1071
Study Start Date: September 2006
Study Completion Date: February 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868283

  Show 49 Study Locations
Sponsors and Collaborators
Ever Neuro Pharma GmbH
Excel PharmaStudies, Inc.
idv Datenanalyse und Versuchsplanung
Investigators
Study Director: Philipp Novak, PhD EVER Neuro Pharma
Principal Investigator: Zhen Hong, MD Huashan Hospital, affiliated Fudan University
  More Information

No publications provided by Ever Neuro Pharma GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Philipp Novak, EVER Neuro Pharma
ClinicalTrials.gov Identifier: NCT00868283     History of Changes
Other Study ID Numbers: EBE-CN-050823
Study First Received: March 23, 2009
Last Updated: July 6, 2011
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014