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Trial · Observational

CompletedPhase not statedRegistry data

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

Short name C-REGS2

NCTNCT03480698 (opens ClinicalTrials.gov in a new tab)Other idEVER-AT0717
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
1,851 participants (actual)
Sponsor
Ever Neuro Pharma GmbH · Industry
Design
Not stated
Countries
1 country

Austria

Start
24 Apr 2018
Primary completion
30 Apr 2024
Completion
15 Jul 2024
First posted
29 Mar 2018
Last update posted
25 Feb 2025
Conditions
Acute Ischemic Stroke

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. Ph –

    C-REGS2

    NCT03480698

    24 Apr 2018 to 15 Jul 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CerebrolysinDrug

Arms2

  • Other

    Cerebrolysin and standard stroke care

  • Other

    Standard stroke care

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Ordinal modified Rankin Scale (mRS) at 3 months after stroke onset

    Time frame · 3 months

    Registry description

    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(5)

  1. Ordinal NIH Stroke Scale (NIHSS) at 21 days and 3 months after stroke onset

    Time frame · Day 21 and 3 months

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2025

9 results

C-REGS2-A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke.

Vosko et al. 2025International journal of stroke : official journal of the International Stroke Societycited by 2

PMID 40851188PMC12589672DOI 10.1177/17474930251375439PUB-40851188

Free to read · publisher termsCC BY-NC9 results
Read at sourceSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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