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NCT Number: NCT03480698

Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landesklinikum Amstetten, Amstetten, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cerebrolysin

Drug

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ever Neuro Pharma GmbH

Industry

Collaborators

  • IDV Data analysis and study planning Dr. Rahlfs

Registry information

Official study 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

Acronym: C-REGS2

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2018
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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