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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480698
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2022
Sponsor:
Collaborator:
IDV Data analysis and study planning Dr. Rahlfs
Information provided by (Responsible Party):
Ever Neuro Pharma GmbH

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Acute Ischemic Stroke 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
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
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Ordinal NIH Stroke Scale (NIHSS) at 21 days and 3 months after stroke onset [ Time Frame: Day 21 and 3 months ]
    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.

  2. Ordinal modified Rankin Scale (mRS) at 21 days after stroke onset [ Time Frame: 21 days ]
    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. Proportion of patients with excellent recovery (mRS score 0-1) 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.

  4. Proportion of patients with functional independence (mRS score 0-2) 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. Ordinal MoCA at 3 months after stroke [ Time Frame: 3 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480698


Contacts
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Contact: Marion Jech, Dr +43 7665 20555 ext 416 marion.jech@everpharma.com
Contact: Stefan Winter, Dr +43 7665 20555 ext 422 stefan.winter@everpharma.com

Locations
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Austria
Landesklinikum Amstetten Recruiting
Amstetten, Austria, 3300
Contact: Susanne Asenbaum-Nan, MD, MBA, MSc         
Krankenhaus der Barmherzigen Brüder Eisenstadt Recruiting
Eisenstadt, Austria, 7000
Contact: Dimitre Staykov, MD         
Universitätsklinik Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Stefan Kiechl, Prof. Dr.         
Kepler Universitätsklinikum Recruiting
Linz, Austria, 4021
Contact: Milan Vosko, Dr., PhD         
CDK Salzburg, Universitätsklinik für Neurologie Recruiting
Salzburg, Austria, 5020
Contact: Johannes Mutzenbach, Dr.         
UK St. Pölten Recruiting
St. Pölten, Austria, 3100
Contact: Stefan Oberndorfer, MD         
UK Tulln Recruiting
Tulln, Austria, 3430
Contact: Cornelia Brunner, MD         
LK Wiener Neustadt Recruiting
Wiener Neustadt, Austria, 2700
Contact: Peter Schnider, MD         
Sponsors and Collaborators
Ever Neuro Pharma GmbH
IDV Data analysis and study planning Dr. Rahlfs
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Ever Neuro Pharma GmbH
ClinicalTrials.gov Identifier: NCT03480698    
Other Study ID Numbers: EVER-AT0717
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ever Neuro Pharma GmbH:
acute ischemic stroke
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Cerebrolysin
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents