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

December 11, 2023 updated by: Ever Neuro Pharma GmbH

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1071

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Anhui, China
        • Anhui Shengli Hospital
      • Anshan, China
        • Anshan hospital
      • Baotou, China
        • Baotou Center Hospital
      • Baotou, China
        • Third hospital, affiliated Neimenggu Medical University (Bao Gang hospital)
      • Beijing, China
        • Sino-Japanese Friendship Hospital
      • Beijing, China
        • Beijing PLA General Hospital
      • Beijing, China
        • First hospital, affiliated Peking University
      • Beijing, China
        • Friendship Hospital, affiliated Capital Medical University
      • Beijing, China
        • Peking Anzhen Hospital
      • Canton, China
        • Guangzhou 2nd People's Hospital
      • Changchun, China
        • First hospital, affiliated Bethune Medical University
      • Changchun, China
        • Second Hospital Affiliated Bethune Medical University
      • Changsha, China
        • Xiangya Hospital, affiliated Hunan Medical University
      • Chengdu, China
        • Chengdu 2nd People's Hospital
      • Chengdu, China
        • First Hospital, affiliated Huaxi Medical University
      • Chengdu, China
        • Sichuan Province People's Hospital
      • Chongqing, China
        • Second Hospital, affiliated Chongqing Med. University
      • Dalian, China
        • Dalian Center Hospital
      • Dalian, China
        • Dalian third people Hospital
      • Dalian, China
        • Second Hospital, affiliated Wenzhou Med. University
      • Fuzhou, China
        • First hospital, affiliated Fujian Medical University
      • Fuzhou, China
        • FuJian Shengli Hospital
      • Guandong, China
        • First Hospital, affiliated Shantou Medical University
      • Guangzhou, China
        • Guangzhou red cross hospital
      • Hangzhou, China
        • First Hospital, affiliated Medical college Zhejing University
      • Harbin, China
        • The 4st Hospital affiliated Harbin Medical University
      • Kunming, China
        • Second Hospital, affiliated Kunming Med. University
      • Mudanjiang, China
        • Yinchuan People's Hospital
      • Nanjing, China
        • Nanjing PLA General Hospital
      • Nanjing, China
        • Zhongda Hospital
      • Qingdao, China
        • First Hospital, affiliated Qingdao Medical University
      • Shanghai, China
        • Huashan Hospital, affiliated Fudan University
      • Shanghai, China
        • Renji Hospital, affiliated Second Medical University
      • Shanghai, China
        • Ruijin Hospital, affiliated Jiaotong University
      • Shanghai, China
        • Shanghai 6th People's Hospital
      • Shanghai, China
        • Xinhua hospital of Shanghai Jiaotong University School of Medicine
      • Shanghai, China
        • Zhongshan Hospital, affiliated Fudan University
      • Shijiazhuang, China
        • Hebei Province People's Hospital
      • Tianjin, China
        • Tianjin First Medical Center
      • Tianjin, China
        • Tianjin Union Medicine Centre
      • Wuhan, China
        • Union Hospital, affiliated Huazhong science and technology University
      • Yinchuan, China
        • First hospital, affiliated NingXia Mededical University
      • Zhengzhou, China
        • First hospital, affiliated Henan Medical University
    • Heilongjiang
      • Mudanjiang, Heilongjiang, China
        • Mudanjiang 1st people Hospital
      • Mudanjiang, Heilongjiang, China
        • Mudanjiang 2nd people Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Chinese University of Hong Kong
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • East-west neo medical center
      • Seoul, Korea, Republic of
        • Kyung-Hee University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Rankin Scale
Time Frame: 90 days after start of treatment
90 days after start of treatment
Barthel Index
Time Frame: 90 days after start of treatment
90 days after start of treatment
NIH Stroke Scale
Time Frame: 90 days after start of treatment
90 days after start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-12
Time Frame: 90 days after start of treatment
90 days after start of treatment
Overall mortality
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ever Neuro Pharma GmbH

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 23, 2009

First Posted (Estimated)

March 24, 2009

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBE-CN-050823

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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