Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT02541227
Status:
TERMINATED
Last Update Posted:
2022-04-06
First Post:
2015-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cerebrolysin REGistry Study in Stroke
Sponsor:
Ever Neuro Pharma GmbH
Organization:
Study Overview
Official Title:
Cerebrolysin REGistry Study in Stroke A Registry Study to Assess Practices, Safety and Effectiveness of Cerebrolysin in Routine Treatment of Acute Ischemic Stroke
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The goal to match 1000 patients per group could not be achieved with reasonable effort and in reasonable time.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CREGS-S
Brief Summary:
Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with acute ischemic stroke.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: