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

Sponsor

Ever Neuro Pharma GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT00868283

Collaborator

Excel PharmaStudies, Inc. (Industry), idv Datenanalyse und Versuchsplanung (Other)

1,071

Enrollment

Locations

Arms

Duration (Months)

21.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Cerebrolysin Drug: 0.9% Saline Solution	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1071 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

SF-12 [90 days after start of treatment]
Overall mortality [Throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Mudanjiang 1st people Hospital	Mudanjiang	Heilongjiang	China
2	Mudanjiang 2nd people Hospital	Mudanjiang	Heilongjiang	China
3	Anhui Shengli Hospital	Anhui		China
4	Anshan hospital	Anshan		China
5	Baotou Center Hospital	Baotou		China
6	Third hospital, affiliated Neimenggu Medical University (Bao Gang hospital)	Baotou		China
7	Beijing PLA General Hospital	Beijing		China
8	First hospital, affiliated Peking University	Beijing		China
9	Friendship Hospital, affiliated Capital Medical University	Beijing		China
10	Peking Anzhen Hospital	Beijing		China
11	Sino-Japanese Friendship Hospital	Beijing		China
12	Guangzhou 2nd People's Hospital	Canton		China
13	First hospital, affiliated Bethune Medical University	Changchun		China
14	Second Hospital Affiliated Bethune Medical University	Changchun		China
15	Xiangya Hospital, affiliated Hunan Medical University	Changsha		China
16	Chengdu 2nd People's Hospital	Chengdu		China
17	First Hospital, affiliated Huaxi Medical University	Chengdu		China
18	Sichuan Province People's Hospital	Chengdu		China
19	Second Hospital, affiliated Chongqing Med. University	Chongqing		China
20	Dalian Center Hospital	Dalian		China
21	Dalian third people Hospital	Dalian		China
22	Second Hospital, affiliated Wenzhou Med. University	Dalian		China
23	First hospital, affiliated Fujian Medical University	Fuzhou		China
24	FuJian Shengli Hospital	Fuzhou		China
25	First Hospital, affiliated Shantou Medical University	Guandong		China
26	Guangzhou red cross hospital	Guangzhou		China
27	First Hospital, affiliated Medical college Zhejing University	Hangzhou		China
28	The 4st Hospital affiliated Harbin Medical University	Harbin		China
29	Second Hospital, affiliated Kunming Med. University	Kunming		China
30	Yinchuan People's Hospital	Mudanjiang		China
31	Nanjing PLA General Hospital	Nanjing		China
32	Zhongda Hospital	Nanjing		China
33	First Hospital, affiliated Qingdao Medical University	Qingdao		China
34	Huashan Hospital, affiliated Fudan University	Shanghai		China
35	Renji Hospital, affiliated Second Medical University	Shanghai		China
36	Ruijin Hospital, affiliated Jiaotong University	Shanghai		China
37	Shanghai 6th People's Hospital	Shanghai		China
38	Xinhua hospital of Shanghai Jiaotong University School of Medicine	Shanghai		China
39	Zhongshan Hospital, affiliated Fudan University	Shanghai		China
40	Hebei Province People's Hospital	Shijiazhuang		China
41	Tianjin First Medical Center	Tianjin		China
42	Tianjin Union Medicine Centre	Tianjin		China
43	Union Hospital, affiliated Huazhong science and technology University	Wuhan		China
44	First hospital, affiliated NingXia Mededical University	Yinchuan		China
45	First hospital, affiliated Henan Medical University	Zhengzhou		China
46	Chinese University of Hong Kong	Hong Kong		Hong Kong
47	Asan medical center	Seoul		Korea, Republic of
48	East-west neo medical center	Seoul		Korea, Republic of
49	Kyung-hee University Hospital	Seoul		Korea, Republic of