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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Cerebrolysin
0.9% Saline Solution
Sponsored by
Ever Neuro Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cerebrolysin

0.9% Saline Solution

Arm Description

Outcomes

Primary Outcome Measures

Modified Rankin Scale
Barthel Index
NIH Stroke Scale

Secondary Outcome Measures

SF-12
Overall mortality

Full Information

First Posted
March 23, 2009
Last Updated
July 6, 2011
Sponsor
Ever Neuro Pharma GmbH
Collaborators
Excel PharmaStudies, Inc., idv Datenanalyse und Versuchsplanung
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1. Study Identification

Unique Protocol Identification Number
NCT00868283
Brief Title
The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
Acronym
CASTA
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ever Neuro Pharma GmbH
Collaborators
Excel PharmaStudies, Inc., idv Datenanalyse und Versuchsplanung

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1071 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cerebrolysin
Arm Type
Experimental
Arm Title
0.9% Saline Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin
Intervention Description
30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.
Intervention Type
Drug
Intervention Name(s)
0.9% Saline Solution
Other Intervention Name(s)
NaCl
Intervention Description
30 ml will be given once daily by intravenous infusion for 10 consecutive days.
Primary Outcome Measure Information:
Title
Modified Rankin Scale
Time Frame
90 days after start of treatment
Title
Barthel Index
Time Frame
90 days after start of treatment
Title
NIH Stroke Scale
Time Frame
90 days after start of treatment
Secondary Outcome Measure Information:
Title
SF-12
Time Frame
90 days after start of treatment
Title
Overall mortality
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Novak, PhD
Organizational Affiliation
EVER Neuro Pharma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhen Hong, MD
Organizational Affiliation
Huashan Hospital, affiliated Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mudanjiang 1st people Hospital
City
Mudanjiang
State/Province
Heilongjiang
Country
China
Facility Name
Mudanjiang 2nd people Hospital
City
Mudanjiang
State/Province
Heilongjiang
Country
China
Facility Name
Anhui Shengli Hospital
City
Anhui
Country
China
Facility Name
Anshan hospital
City
Anshan
Country
China
Facility Name
Baotou Center Hospital
City
Baotou
Country
China
Facility Name
Third hospital, affiliated Neimenggu Medical University (Bao Gang hospital)
City
Baotou
Country
China
Facility Name
Beijing PLA General Hospital
City
Beijing
Country
China
Facility Name
First hospital, affiliated Peking University
City
Beijing
Country
China
Facility Name
Friendship Hospital, affiliated Capital Medical University
City
Beijing
Country
China
Facility Name
Peking Anzhen Hospital
City
Beijing
Country
China
Facility Name
Sino-Japanese Friendship Hospital
City
Beijing
Country
China
Facility Name
Guangzhou 2nd People's Hospital
City
Canton
Country
China
Facility Name
First hospital, affiliated Bethune Medical University
City
Changchun
Country
China
Facility Name
Second Hospital Affiliated Bethune Medical University
City
Changchun
Country
China
Facility Name
Xiangya Hospital, affiliated Hunan Medical University
City
Changsha
Country
China
Facility Name
Chengdu 2nd People's Hospital
City
Chengdu
Country
China
Facility Name
First Hospital, affiliated Huaxi Medical University
City
Chengdu
Country
China
Facility Name
Sichuan Province People's Hospital
City
Chengdu
Country
China
Facility Name
Second Hospital, affiliated Chongqing Med. University
City
Chongqing
Country
China
Facility Name
Dalian Center Hospital
City
Dalian
Country
China
Facility Name
Dalian third people Hospital
City
Dalian
Country
China
Facility Name
Second Hospital, affiliated Wenzhou Med. University
City
Dalian
Country
China
Facility Name
First hospital, affiliated Fujian Medical University
City
Fuzhou
Country
China
Facility Name
FuJian Shengli Hospital
City
Fuzhou
Country
China
Facility Name
First Hospital, affiliated Shantou Medical University
City
Guandong
Country
China
Facility Name
Guangzhou red cross hospital
City
Guangzhou
Country
China
Facility Name
First Hospital, affiliated Medical college Zhejing University
City
Hangzhou
Country
China
Facility Name
The 4st Hospital affiliated Harbin Medical University
City
Harbin
Country
China
Facility Name
Second Hospital, affiliated Kunming Med. University
City
Kunming
Country
China
Facility Name
Yinchuan People's Hospital
City
Mudanjiang
Country
China
Facility Name
Nanjing PLA General Hospital
City
Nanjing
Country
China
Facility Name
Zhongda Hospital
City
Nanjing
Country
China
Facility Name
First Hospital, affiliated Qingdao Medical University
City
Qingdao
Country
China
Facility Name
Huashan Hospital, affiliated Fudan University
City
Shanghai
Country
China
Facility Name
Renji Hospital, affiliated Second Medical University
City
Shanghai
Country
China
Facility Name
Ruijin Hospital, affiliated Jiaotong University
City
Shanghai
Country
China
Facility Name
Shanghai 6th People's Hospital
City
Shanghai
Country
China
Facility Name
Xinhua hospital of Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
Zhongshan Hospital, affiliated Fudan University
City
Shanghai
Country
China
Facility Name
Hebei Province People's Hospital
City
Shijiazhuang
Country
China
Facility Name
Tianjin First Medical Center
City
Tianjin
Country
China
Facility Name
Tianjin Union Medicine Centre
City
Tianjin
Country
China
Facility Name
Union Hospital, affiliated Huazhong science and technology University
City
Wuhan
Country
China
Facility Name
First hospital, affiliated NingXia Mededical University
City
Yinchuan
Country
China
Facility Name
First hospital, affiliated Henan Medical University
City
Zhengzhou
Country
China
Facility Name
Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Asan medical center
City
Seoul
Country
Korea, Republic of
Facility Name
East-west neo medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung-hee University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22282884
Citation
Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z; Cerebrolysin Acute Stroke Treatment in Asia (CASTA) Investigators. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial. Stroke. 2012 Mar;43(3):630-6. doi: 10.1161/STROKEAHA.111.628537. Epub 2012 Jan 26.
Results Reference
derived

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

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