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NCT Number: NCT00868283

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mudanjiang 1st people Hospital, Mudanjiang, Heilongjiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cerebrolysin

Drug

30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.

0.9% saline solution

Drug

30 ml will be given once daily by intravenous infusion for 10 consecutive days.

Other names: NaCl

Primary outcomes

  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 outcomes

  1. SF-12

    Time frame: 90 days after start of treatment

  2. Overall mortality

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Ever Neuro Pharma GmbH

Industry

Collaborators

  • Excel PharmaStudies, Inc.
  • idv Datenanalyse und Versuchsplanung

Registry information

Official study title

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

Acronym: CASTA

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Mar 24, 2009
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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