NCT03480698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,851

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

6 years

First QC Date

March 22, 2018

Last Update Submit

February 24, 2025

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

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

    Day 21 and 3 months

  • Ordinal modified Rankin Scale (mRS) at 21 days after stroke onset

    21 days

  • Proportion of patients with excellent recovery (mRS score 0-1) at 3 months after stroke onset

    3 months

  • Proportion of patients with functional independence (mRS score 0-2) at 3 months after stroke onset

    3 months

  • Ordinal MoCA at 3 months after stroke

    3 months

Study Arms (2)

Cerebrolysin and standard stroke care

Drug: Cerebrolysin

Standard stroke care

Interventions

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.

Cerebrolysin and standard stroke care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Landesklinikum Amstetten

Amstetten, 3300, Austria

Location

Krankenhaus der Barmherzigen Brüder Eisenstadt

Eisenstadt, 7000, Austria

Location

Universitätsklinik Innsbruck

Innsbruck, 6020, Austria

Location

Kepler Universitätsklinikum

Linz, 4021, Austria

Location

CDK Salzburg, Universitätsklinik für Neurologie

Salzburg, 5020, Austria

Location

UK St. Pölten

Sankt Pölten, 3100, Austria

Location

UK Tulln

Tulln, 3430, Austria

Location

LK Wiener Neustadt

Wiener Neustadt, 2700, Austria

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2018

First Posted

March 29, 2018

Study Start

April 24, 2018

Primary Completion

April 30, 2024

Study Completion

July 15, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(8)