An observational study in Ischemic Stroke, sponsored by Ever Neuro Pharma GmbH. Terminated at 1 site in Austria. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Ever Neuro Pharma GmbH · Observational
Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with acute ischemic stroke.
Stroke is a devastating disease and one of the primary causes for death and long term morbidity imposing a heavy burden on patients, relatives and the health care system. Except for fibrinolytic therapy, which is only possible in a minor fraction of patients, there is no widely approved medication for the treatment of acute stroke.
Cerebrolysin has been approved for the treatment of stroke in over 45 countries worldwide.
Since the approval of Cerebrolysin, stroke therapy has evolved, namely, with improved overall care, stroke units, more targeted rehabilitation, and the increasing availability of fibrinolytic therapy (rtPA, Actilyse) in specialized centers throughout the world. More recently, interventional therapies with various thrombus retrievers have emerged.
In addition the Cerebrolysin treatment in stroke has evolved with different time windows, dosages and lengths of therapy being given in a pragmatic way by physicians within the specification of Product Characteristics for Cerebrolysin (SPC). The main aim of this study is to capture these variables of the Cerebrolysin treatment and its comedication in order to give guidance to further research. This research may consist of an extension of the current registry or targeted research in one or several subgroups of patients responding to Cerebrolysin treatment.
It is therefore the overall aim of this registry study to monitor the effectiveness and safety of Cerebrolysin therapy against the background of the now established and evolving stroke therapies. In the concomitant control group these therapies alone or in combination will be compared to the addition of Cerebrolysin in these patients. Of particular interest is the treatment in stroke units, with rtPA and systematic rehabilitation.
An open observational treatment design has been chosen to collect data to capture the therapies as applied in real clinical practice and to avoid the selection bias typical for controlled studies excluding the majority of patients from participation. In order to overcome the observational bias as major and inherent limitation of open trial designs, a remote and blinded assessment will be done: after three months treatment the patients' assessment of the modified Rankin Scale (mRS, a widely accepted primary outcome parameter) will be -after specific informed consent- video-taped and subsequently assessed by at least two independent and blinded assessors experienced in the remote assessment of the mRS.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 1,823 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Ever Neuro Pharma GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients receive acute ishemic stroke care according to local treatment standards, not amended or influenced by the study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization
Drug: Cerebrolysin
Patients who are not treated with Cerebrolysin; treatment follows local clinical practice
Cerebrolysin dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization
Modified Rankin Scale
Ordinal analysis of the mRS on day 90 was chosen as statistically powerful primary endpoint, as it is robust to case mix, clinically relevant and treatment-responsive.
Time frame: 90 days
The National Institutes of Health Stroke Scale (NIHSS)
Ordinal NIHSS at 3 months after stroke onset o Home Time (number of nights among the first 90 days after stroke onset that the patient spends in his own or a relative's private home)
Time frame: 90 days
Montreal Cognitive Assessment (MoCA)
Ordinal MoCA assessment of cognitive functions at 3 months after stroke
Time frame: 90 days
Home Time (number of nights among the first 90 days after stroke onset that the patient spends in his own or a relative's private home)
Time frame: 90 days
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Ever Neuro Pharma GmbH