Clinical trial

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

Name

EVER-AT0717

Description

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 arms

Trial start

2018-04-24

Estimated PCD

2024-04-15

Trial end

2024-09-30

Status

Recruiting

Treatment

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.

Arms:

Cerebrolysin and standard stroke care

Size

2000

Primary endpoint

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

3 months

Eligibility 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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '90 Days', 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 2000, 'type': 'ESTIMATED'}}

Updated at

2023-12-12

1 organization

1 product

1 indication

Organization

Ever Neuro Pharma

Product

Cerebrolysin

Indication

Stroke