Acute Ischemic StrokeC-REGS2NCT03480698
Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness
An observational study of Acute Ischemic Stroke, run by Ever Neuro Pharma GmbH at 8 sites in Austria.
Trial summary
This study investigates the clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with moderate to severe neurological deficits after acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Cerebrolysin
- Type of treatment
- Injection or infusion
- How many people
- 1,851 participants
- Where
- 8 sitesAustria
- Study dates
- 24 Apr 2018to 15 Jul 2024
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe neurological deficits after acute ischemic stroke (NIHSS 8-15) at baseline
Who may be able to join
- Signed Informed Consent
- Clinical diagnosis of acute ischemic stroke confirmed by imaging
- Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive
- No prior stroke
- No prior disability
- Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1)
- Reasonable expectation of successful follow-up (max. 100 days)
Who cannot join
- none
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Austria8 sites
Landesklinikum Amstetten
Amstetten, 3300
Krankenhaus der Barmherzigen Brüder Eisenstadt
Eisenstadt, 7000
Universitätsklinik Innsbruck
Innsbruck, 6020
Kepler Universitätsklinikum
Linz, 4021
CDK Salzburg, Universitätsklinik für Neurologie
Salzburg, 5020
UK St. Pölten
Sankt Pölten, 3100
UK Tulln
Tulln, 3430
LK Wiener Neustadt
Wiener Neustadt, 2700
About this study
Official title: C-REGS2 - a Registry Study to Observe Clinical Practices, Safety and Efficiency of Routine Use of Cerebrolysin in the Treatment of Patients with Moderate to Severe Neurological Deficits After Acute Ischaemic Stroke
This study investigates the clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with moderate to severe neurological deficits after acute ischemic stroke.
Read the detailed description
Patients registered: Acute Ischemic Stroke patients with moderate to severe neurological deficits
All patients receive acute stroke care according to local treatment standards, not amended or influenced by the study:
Cerebrolysin Group:
Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with terms of the local marketing authorization
Control group:
Patients who are not treated with Cerebrolysin
Observation criteria:
- Signed Informed Consent
- Clinical diagnosis of acute ischemic stroke confirmed by imaging
- Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive
- No prior stroke
- No prior disability
- Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1)
- Reasonable expectation of successful follow-up (max. 100 days)
The study follows the recommendations of the Principles for Good Research on Comparative Effectiveness (GRACE).
In order to comply with recent calls for high-quality non-interventional comparative effectiveness research, a risk-based centralized statistical approach to monitoring is introduced in combination with targeted on-site monitoring for ongoing surveillance of study conduct, thus ensuring highest standards of data quality and integrity according to the most recent requirements of the ICH E6 Guideline for Good Clinical Practice (GCP, Amendment R2, July 2015), the FDA Guidance for Industry on a Risk-based Approach to Monitoring, and the EMA reflection-paper on risk-based quality management in clinical trials.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Cerebrolysin
- Keywords
- acute ischemic stroke
- 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
Dosage, frequency, duration and mode of administration of Cerebrolysin follow the local hospital practice in accordance with the terms of the local marketing authorization and is not amended or influenced by the study. Prescribed Cerebrolysin will be used as solution for injection/concentrate for solution for infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin and standard stroke care | Not described Receives: Drug: Cerebrolysin | |
| Standard stroke care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ordinal modified Rankin Scale (mRS) at 3 months after stroke onset
The modified Rankin Scale scale is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
Measured: 3 months
Secondary outcomes (5)
Ordinal NIH Stroke Scale (NIHSS) at 21 days and 3 months after stroke onset
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: Day 21 and 3 months
Ordinal modified Rankin Scale (mRS) at 21 days after stroke onset
The modified Rankin Scale scale is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
Measured: 21 days
Proportion of patients with excellent recovery (mRS score 0-1) at 3 months after stroke onset
The modified Rankin Scale scale is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
Measured: 3 months
Proportion of patients with functional independence (mRS score 0-2) at 3 months after stroke onset
The modified Rankin Scale scale is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
Measured: 3 months
Ordinal MoCA at 3 months after stroke
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. The MoCA test is a one-page 30-point test administered in approximately 10 minutes. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start24 Apr 2018
- Primary completion30 Apr 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,851 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Ever Neuro Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IDV Data analysis and study planning Dr. Rahlfs
- Responsible party
- Sponsor
- Investigators
- Michael Brainin, Univ.-Prof. Dr., Study director, Danube University Krems - Head of the Department for Clinical Neuroscience and Preventive Medicine / Head of the Center for Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480698
- Sponsor's protocol ID
- EVER-AT0717
- Acronym
- C-REGS2
- Status last verified
- Feb 2025
- First submitted
- 22 Mar 2018
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vosko MR, Sanak D, Do Y, Vatanagul JS, Roushdy T, Bornstein NM, Vester JC, Brainin M. C-REGS2-A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke. Int J Stroke. 2025 Oct;20(9):1060-1070. doi: 10.1177/17474930251375439. Epub 2025 Aug 24.
PubMed 40851188
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-REGS2 - a Registry Study to Observe Clinical Practices, Safety and Efficiency of Routine Use of Cerebrolysin in the Treatment of Patients with Moderate to Severe Neurological Deficits After Acute Ischaemic Stroke
- ClinicalTrials.gov ID
- NCT03480698
- Acronym / sponsor ID
- C-REGS2 / EVER-AT0717
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,851 participants (actual)
- Lead sponsor
- Ever Neuro Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- IDV Data analysis and study planning Dr. Rahlfs
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
This study investigates the clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with moderate to severe neurological deficits after acute ischemic stroke.
Detailed description
Patients registered: Acute Ischemic Stroke patients with moderate to severe neurological deficits
All patients receive acute stroke care according to local treatment standards, not amended or influenced by the study:
Cerebrolysin Group:
Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with terms of the local marketing authorization
Control group:
Patients who are not treated with Cerebrolysin
Observation criteria:
- Signed Informed Consent
- Clinical diagnosis of acute ischemic stroke confirmed by imaging
- Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive
- No prior stroke
- No prior disability
- Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1)
- Reasonable expectation of successful follow-up (max. 100 days)
The study follows the recommendations of the Principles for Good Research on Comparative Effectiveness (GRACE).
In order to comply with recent calls for high-quality non-interventional comparative effectiveness research, a risk-based centralized statistical approach to monitoring is introduced in combination with targeted on-site monitoring for ongoing surveillance of study conduct, thus ensuring highest standards of data quality and integrity according to the most recent requirements of the ICH E6 Guideline for Good Clinical Practice (GCP, Amendment R2, July 2015), the FDA Guidance for Industry on a Risk-based Approach to Monitoring, and the EMA reflection-paper on risk-based quality management in clinical trials.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin and standard stroke care | – | Drug: Cerebrolysin |
| Standard stroke care | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe neurological deficits after acute ischemic stroke (NIHSS 8-15) at baseline
Key inclusion criteria (7 listed)
- Signed Informed Consent
- Clinical diagnosis of acute ischemic stroke confirmed by imaging
- Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive
- No prior stroke
- No prior disability
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| CerebrolysinDosage, frequency, duration and mode of administration of Cerebrolysin follow the local hospital practice in accordance with the terms of the local marketing authorization and is not amended or influenced by the study. Prescribed Cerebrolysin will be used as solution for injection/concentrate for solution for infusion. | Drug | Cerebrolysin and standard stroke care |
Primary outcome
Ordinal modified Rankin Scale (mRS) at 3 months after stroke onset
Time frame: 3 months
The modified Rankin Scale scale is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
5 secondary outcomes
Ordinal NIH Stroke Scale (NIHSS) at 21 days and 3 months after stroke onset
Time frame: Day 21 and 3 months
Ordinal modified Rankin Scale (mRS) at 21 days after stroke onset
Time frame: 21 days
Proportion of patients with excellent recovery (mRS score 0-1) at 3 months after stroke onset
Time frame: 3 months
Proportion of patients with functional independence (mRS score 0-2) at 3 months after stroke onset
Time frame: 3 months
Ordinal MoCA at 3 months after stroke
Time frame: 3 months
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 25 Feb 2025.
- Derived from this study: PubMed 40851188Vosko MR, Sanak D, Do Y, Vatanagul JS, Roushdy T, Bornstein NM, Vester JC, Brainin M. C-REGS2-A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke. Int J Stroke. 2025 Oct;20(9):1060-1070. doi: 10.1177/17474930251375439. Epub 2025 Aug 24.
- Individual participant dataSharing planned: No
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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.
Michael Brainin, Univ.-Prof. Dr. study director
Danube University Krems - Head of the Department for Clinical Neuroscience and Preventive Medicine / Head of the Center for Neurosciences
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Ever Neuro Pharma GmbH at 8 sites in Austria.
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 7 inclusion and 1 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Ordinal modified Rankin Scale (mRS) at 3 months after stroke onset (time frame: 3 months). 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 NCT03480698, which also lists 1 linked publication.
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 25 Feb 2025.