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

Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868283
• Other study ID #: EBE-CN-050823
• Status: Completed
• Phase: Phase 4
• Start date: September 2006
• Est. completion date: February 2011

Study information

• Verified date: December 2023
• Source: Ever Neuro Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1071
• Est. completion date: February 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Cerebrolysin
30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.
• 0.9% Saline Solution
30 ml will be given once daily by intravenous infusion for 10 consecutive days.

Locations

Country	Name	City	State
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	Guangzhou 2nd People's Hospital	Canton
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 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	Mudanjiang 1st people Hospital	Mudanjiang	Heilongjiang
China	Mudanjiang 2nd people Hospital	Mudanjiang	Heilongjiang
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
Hong Kong	Chinese University of Hong Kong	Hong Kong
Korea, Republic of	Asan medical center	Seoul
Korea, Republic of	East-west neo medical center	Seoul
Korea, Republic of	Kyung-hee University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Ever Neuro Pharma GmbH	Excel PharmaStudies, Inc., idv Datenanalyse und Versuchsplanung

Countries where clinical trial is conducted

China,  Hong Kong,  Korea, Republic of, 

References & Publications (3)

Bornstein 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 — View 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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale		90 days after start of treatment
Primary	Barthel Index		90 days after start of treatment
Primary	NIH Stroke Scale		90 days after start of treatment
Secondary	SF-12		90 days after start of treatment
Secondary	Overall mortality		Throughout the study

External Links

•   Meta analytic results