The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
- Registration Number
- NCT00868283
- Lead Sponsor
- Ever Neuro Pharma GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1071
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.9% Saline Solution 0.9% Saline Solution - Cerebrolysin Cerebrolysin -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method SF-12 90 days after start of treatment Overall mortality Throughout the study
Trial Locations
- Locations (49)
Dalian third people Hospital
🇨🇳Dalian, China
FuJian Shengli Hospital
🇨🇳Fuzhou, China
The 4st Hospital affiliated Harbin Medical University
🇨🇳Harbin, China
Union Hospital, affiliated Huazhong science and technology University
🇨🇳Wuhan, China
East-west neo medical center
🇰🇷Seoul, Korea, Republic of
First Hospital, affiliated Shantou Medical University
🇨🇳Guandong, China
First hospital, affiliated NingXia Mededical University
🇨🇳Yinchuan, China
Asan medical center
🇰🇷Seoul, Korea, Republic of
Anshan hospital
🇨🇳Anshan, China
Chengdu 2nd People's Hospital
🇨🇳Chengdu, China
First Hospital, affiliated Huaxi Medical University
🇨🇳Chengdu, China
Sichuan Province People's Hospital
🇨🇳Chengdu, China
Dalian Center Hospital
🇨🇳Dalian, China
Second Hospital, affiliated Wenzhou Med. University
🇨🇳Dalian, China
Guangzhou red cross hospital
🇨🇳Guangzhou, China
Second Hospital, affiliated Kunming Med. University
🇨🇳Kunming, China
Yinchuan People's Hospital
🇨🇳Mudanjiang, China
Huashan Hospital, affiliated Fudan University
🇨🇳Shanghai, China
Ruijin Hospital, affiliated Jiaotong University
🇨🇳Shanghai, China
Zhongshan Hospital, affiliated Fudan University
🇨🇳Shanghai, China
Mudanjiang 1st people Hospital
🇨🇳Mudanjiang, Heilongjiang, China
Anhui Shengli Hospital
🇨🇳Anhui, China
Third hospital, affiliated Neimenggu Medical University (Bao Gang hospital)
🇨🇳Baotou, China
Mudanjiang 2nd people Hospital
🇨🇳Mudanjiang, Heilongjiang, China
Baotou Center 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
Guangzhou 2nd People's Hospital
🇨🇳Canton, China
Second Hospital Affiliated Bethune Medical University
🇨🇳Changchun, China
Xiangya Hospital, affiliated Hunan Medical University
🇨🇳Changsha, China
Second Hospital, affiliated Chongqing Med. University
🇨🇳Chongqing, China
First hospital, affiliated Fujian Medical University
🇨🇳Fuzhou, China
First Hospital, affiliated Medical college Zhejing University
🇨🇳Hangzhou, China
First Hospital, affiliated Qingdao Medical University
🇨🇳Qingdao, China
Zhongda Hospital
🇨🇳Nanjing, China
Renji Hospital, affiliated Second Medical University
🇨🇳Shanghai, China
Shanghai 6th People's Hospital
🇨🇳Shanghai, China
Xinhua hospital of Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Hebei Province People's Hospital
🇨🇳Shijiazhuang, China
Tianjin First Medical Center
🇨🇳Tianjin, China
Tianjin Union Medicine Centre
🇨🇳Tianjin, China
First hospital, affiliated Henan Medical University
🇨🇳Zhengzhou, China
Kyung-hee University Hospital
🇰🇷Seoul, Korea, Republic of
Nanjing PLA General Hospital
🇨🇳Nanjing, China
Chinese University of Hong Kong
🇭🇰Hong Kong, Hong Kong