Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness (C-REGS2)

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Cerebrolysin

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 Type: Observational
• Enrollment (Actual): 1851

Contacts and Locations

Study Locations

• Austria
  • Amstetten, Austria, 3300
    • Landesklinikum Amstetten
  • Eisenstadt, Austria, 7000
    • Krankenhaus der Barmherzigen Brüder Eisenstadt
  • Innsbruck, Austria, 6020
    • Universitatsklinik Innsbruck
  • Linz, Austria, 4021
    • Kepler Universitätsklinikum
  • Salzburg, Austria, 5020
    • CDK Salzburg, Universitätsklinik für Neurologie
  • St. Pölten, Austria, 3100
    • UK St. Pölten
  • Tulln, Austria, 3430
    • UK Tulln
  • Wiener Neustadt, Austria, 2700
    • LK Wiener Neustadt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe neurological deficits after acute ischemic stroke (NIHSS 8-15) at baseline

Description

Inclusion 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)

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cerebrolysin and standard stroke care	Drug: Cerebrolysin; 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.
Standard stroke care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	3 months

Collaborators and Investigators

• Sponsor: Ever Neuro Pharma GmbH
• Collaborators: IDV Data analysis and study planning Dr. Rahlfs
• Investigators: Study Director: Michael Brainin, Univ.-Prof. Dr., Danube University Krems - Head of the Department for Clinical Neuroscience and Preventive Medicine / Head of the Center for Neurosciences

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: acute ischemic stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Ischemic Stroke; Stroke; Ischemia; Physiological Effects of Drugs; Protective Agents; Neuroprotective Agents; Nootropic Agents; Cerebrolysin
• Other Study ID Numbers: EVER-AT0717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No