Ischemic StrokePhase 4CASTANCT00868283
The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
A Phase 4 study testing Cerebrolysin and 0.9% Saline Solution in people with Ischemic Stroke, run by Ever Neuro Pharma GmbH at 49 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Cerebrolysin and 0.9% Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,071 participants
- Where
- 49 sitesin 3 countries
- Study dates
- Sep 2006to Feb 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
49 sites in 3 countries.
49 sites in 3 countries
China45 sites
Anhui Shengli Hospital
Anhui
Anshan hospital
Anshan
Baotou Center Hospital
Baotou
Third hospital, affiliated Neimenggu Medical University (Bao Gang hospital)
Baotou
Beijing PLA General Hospital
Beijing
First hospital, affiliated Peking University
Beijing
Friendship Hospital, affiliated Capital Medical University
Beijing
Peking Anzhen Hospital
Beijing
Sino-Japanese Friendship Hospital
Beijing
First hospital, affiliated Bethune Medical University
Changchun
Second Hospital Affiliated Bethune Medical University
Changchun
Xiangya Hospital, affiliated Hunan Medical University
Changsha
Chengdu 2nd People's Hospital
Chengdu
First Hospital, affiliated Huaxi Medical University
Chengdu
Sichuan Province People's Hospital
Chengdu
Second Hospital, affiliated Chongqing Med. University
Chongqing
Dalian Center Hospital
Dalian
Dalian third people Hospital
Dalian
Second Hospital, affiliated Wenzhou Med. University
Dalian
First hospital, affiliated Fujian Medical University
Fuzhou
FuJian Shengli Hospital
Fuzhou
First Hospital, affiliated Shantou Medical University
Guandong
Guangzhou 2nd People's Hospital
Guangzhou
Guangzhou red cross hospital
Guangzhou
First Hospital, affiliated Medical college Zhejing University
Hangzhou
The 4st Hospital affiliated Harbin Medical University
Harbin
Second Hospital, affiliated Kunming Med. University
Kunming
Mudanjiang 1st people Hospital
Mudanjiang, Heilongjiang
Mudanjiang 2nd people Hospital
Mudanjiang, Heilongjiang
Yinchuan People's Hospital
Mudanjiang
Nanjing PLA General Hospital
Nanjing
Zhongda Hospital
Nanjing
First Hospital, affiliated Qingdao Medical University
Qingdao
Huashan Hospital, affiliated Fudan University
Shanghai
Renji Hospital, affiliated Second Medical University
Shanghai
Ruijin Hospital, affiliated Jiaotong University
Shanghai
Shanghai 6th People's Hospital
Shanghai
Xinhua hospital of Shanghai Jiaotong University School of Medicine
Shanghai
Zhongshan Hospital, affiliated Fudan University
Shanghai
Hebei Province People's Hospital
Shijiazhuang
Tianjin First Medical Center
Tianjin
Tianjin Union Medicine Centre
Tianjin
Union Hospital, affiliated Huazhong science and technology University
Wuhan
First hospital, affiliated NingXia Mededical University
Yinchuan
First hospital, affiliated Henan Medical University
Zhengzhou
South Korea3 sites
Asan medical center
Seoul
East-west neo medical center
Seoul
Kyung-hee University Hospital
Seoul
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
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.
- Conditions
- Ischemic Stroke
- Being tested
- Cerebrolysin, 0.9% Saline Solution
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.
0.9% Saline SolutionDrug
Also called NaCl
30 ml will be given once daily by intravenous infusion for 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin | Experimental | Not described Receives: Drug: Cerebrolysin |
| 0.9% Saline Solution | Placebo comparator | Not described Receives: Drug: 0.9% Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
Measured: 90 days after start of treatment
Barthel Index
Measured: 90 days after start of treatment
NIH Stroke Scale
Measured: 90 days after start of treatment
Secondary outcomes (2)
SF-12
Measured: 90 days after start of treatment
Overall mortality
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startSep 2006
- Primary completionOct 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ever Neuro Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Excel PharmaStudies, Inc., idv Datenanalyse und Versuchsplanung
- Responsible party
- Sponsor
- Investigators
- Philipp Novak, PhD, Study director, EVER Neuro PharmaZhen Hong, MD, Principal investigator, Huashan Hospital, affiliated Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868283
- Sponsor's protocol ID
- EBE-CN-050823
- Acronym
- CASTA
- Status last verified
- Dec 2023
- First submitted
- 23 Mar 2009
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19765131Heiss 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.
PubMed 22282884Bornstein 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.
PubMed 29248999
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00868283
- Acronym / sponsor ID
- CASTA / EBE-CN-050823
- Conditions
- Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,071 participants (actual)
- Lead sponsor
- Ever Neuro Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Excel PharmaStudies, Inc., idv Datenanalyse und Versuchsplanung
- Study start
- Sep 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin | Experimental | Drug: Cerebrolysin |
| 0.9% Saline Solution | Placebo comparator | Drug: 0.9% Saline Solution |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebrolysin30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days. | Drug | Cerebrolysin |
| 0.9% Saline SolutionAlso: NaCl30 ml will be given once daily by intravenous infusion for 10 consecutive days. | Drug | 0.9% Saline Solution |
Primary outcome
Modified Rankin Scale
Time frame: 90 days after start of treatment
Barthel Index
Time frame: 90 days after start of treatment
NIH Stroke Scale
Time frame: 90 days after start of treatment
2 secondary outcomes
SF-12
Time frame: 90 days after start of treatment
Overall mortality
Time frame: Throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 19765131Hong 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.
- Results publication: PubMed 22282884Heiss 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 publication: PubMed 29248999Bornstein 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.
- Meta analytic resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Novak, PhD study director
EVER Neuro Pharma
Zhen Hong, MD principal investigator
Huashan Hospital, affiliated Fudan University
49 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cerebrolysin and 0.9% Saline Solution in people with Ischemic Stroke, run by Ever Neuro Pharma GmbH at 49 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in China, South Korea, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 90 days after start of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00868283, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.