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

Acute Ischemic Stroke Clinical Trial

— C-REGS2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03480698
• Other study ID #: EVER-AT0717
• Status: Recruiting
• Start date: April 24, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: Ever Neuro Pharma GmbH
• Contact: Marion Jech, Dr
• Phone: +43 7665 20555
• Email: marion.jech[@]everpharma.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 30, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Austria	Landesklinikum Amstetten	Amstetten
Austria	Krankenhaus der Barmherzigen Brüder Eisenstadt	Eisenstadt
Austria	Universitätsklinik Innsbruck	Innsbruck
Austria	Kepler Universitätsklinikum	Linz
Austria	CDK Salzburg, Universitätsklinik für Neurologie	Salzburg
Austria	UK St. Pölten	St. Pölten
Austria	UK Tulln	Tulln
Austria	LK Wiener Neustadt	Wiener Neustadt

Sponsors (2)

Lead Sponsor	Collaborator
Ever Neuro Pharma GmbH	IDV Data analysis and study planning Dr. Rahlfs

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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