The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
CASTA
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
1 other identifier
interventional
1,071
3 countries
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
Longer than P75 for phase_4
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedDecember 15, 2023
December 1, 2023
4.1 years
March 23, 2009
December 11, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Modified Rankin Scale
90 days after start of treatment
Barthel Index
90 days after start of treatment
NIH Stroke Scale
90 days after start of treatment
Secondary Outcomes (2)
SF-12
90 days after start of treatment
Overall mortality
Throughout the study
Study Arms (2)
Cerebrolysin
EXPERIMENTAL0.9% Saline Solution
PLACEBO COMPARATORInterventions
30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.
30 ml will be given once daily by intravenous infusion for 10 consecutive days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ever Neuro Pharma GmbHlead
- Excel PharmaStudies, Inc.collaborator
- idv Datenanalyse und Versuchsplanungcollaborator
Study Sites (49)
Mudanjiang 1st people Hospital
Mudanjiang, Heilongjiang, China
Mudanjiang 2nd people Hospital
Mudanjiang, Heilongjiang, China
Anhui Shengli Hospital
Anhui, China
Anshan hospital
Anshan, China
Baotou Center Hospital
Baotou, China
Third hospital, affiliated Neimenggu Medical University (Bao Gang hospital)
Baotou, 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
Beijing, China
Sino-Japanese Friendship Hospital
Beijing, China
First hospital, affiliated Bethune Medical University
Changchun, China
Second Hospital Affiliated Bethune Medical University
Changchun, China
Xiangya Hospital, affiliated Hunan Medical University
Changsha, China
Chengdu 2nd People's Hospital
Chengdu, China
First Hospital, affiliated Huaxi Medical University
Chengdu, China
Sichuan Province People's Hospital
Chengdu, China
Second Hospital, affiliated Chongqing Med. University
Chongqing, China
Dalian Center Hospital
Dalian, China
Dalian third people Hospital
Dalian, China
Second Hospital, affiliated Wenzhou Med. University
Dalian, China
First hospital, affiliated Fujian Medical University
Fuzhou, China
FuJian Shengli Hospital
Fuzhou, China
First Hospital, affiliated Shantou Medical University
Guandong, China
Guangzhou 2nd People's Hospital
Guangzhou, China
Guangzhou red cross hospital
Guangzhou, China
First Hospital, affiliated Medical college Zhejing University
Hangzhou, China
The 4st Hospital affiliated Harbin Medical University
Harbin, China
Second Hospital, affiliated Kunming Med. University
Kunming, China
Yinchuan People's Hospital
Mudanjiang, China
Nanjing PLA General Hospital
Nanjing, China
Zhongda Hospital
Nanjing, China
First Hospital, affiliated Qingdao Medical University
Qingdao, 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
Shanghai, China
Hebei Province People's Hospital
Shijiazhuang, China
Tianjin First Medical Center
Tianjin, China
Tianjin Union Medicine Centre
Tianjin, China
Union Hospital, affiliated Huazhong science and technology University
Wuhan, China
First hospital, affiliated NingXia Mededical University
Yinchuan, China
First hospital, affiliated Henan Medical University
Zhengzhou, China
Chinese University of Hong Kong
Hong Kong, Hong Kong
Asan medical center
Seoul, South Korea
East-west neo medical center
Seoul, South Korea
Kyung-hee University Hospital
Seoul, South Korea
Related Publications (3)
Hong Z, Moessler H, Bornstein N, Brainin M, Heiss WD; CASTA-Investigators. A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with acute ischaemic stroke in Asia--CASTA. Int J Stroke. 2009 Oct;4(5):406-12. doi: 10.1111/j.1747-4949.2009.00340.x.
PMID: 19765131BACKGROUNDHeiss 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.
PMID: 22282884RESULTBornstein NM, Guekht A, Vester J, Heiss WD, Gusev E, Homberg V, Rahlfs VW, Bajenaru O, Popescu BO, Muresanu D. Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials. Neurol Sci. 2018 Apr;39(4):629-640. doi: 10.1007/s10072-017-3214-0. Epub 2017 Dec 16.
PMID: 29248999RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Philipp Novak, PhD
EVER Neuro Pharma
- PRINCIPAL INVESTIGATOR
Zhen Hong, MD
Huashan Hospital, affiliated Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 24, 2009
Study Start
September 1, 2006
Primary Completion
October 1, 2010
Study Completion
February 1, 2011
Last Updated
December 15, 2023
Record last verified: 2023-12