A prospective, randomised, placebo controlled, double blind trial about safety and efficacy of combined treatment with Alteplase (rt-PA) and Cerebrolysin(R) in acute ischemic hemispehric stroke - CERE-LYSE-1

Phase 1

• Conditions: Clinical diagnosis of ischemic stroke causing a measurable neurological deficitdefined as impairment of language, motor function, cognition and/or gaze,vision or neglect. CT scan should exclude haemorrhage.; MedDRA version: 6.0Level: LLTClassification code 10055221

• Registration Number: EUCTR2004-001729-11-SK
• Lead Sponsor: EBEWE Pharma GesmbH Nfg.KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-29
• Study Completion: 2008-07-01
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Male and female patients (18-80 years) with ischemic stroke not earlier then 3 hours before onset of thrombolytic treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Evidence of intracranial haemorrhage (ICH) on the CT-scanl
• Failure to perform or to evaluate screening or baseline examinations
• Hospitalisation (except for study purposes) or change of concomitant medication 4 weeks prior to screening or during screening period
• Participation in another therapeutic clinical trial 3 months before baseline
• Patients with any history of prior stroke and concomitant diabetes
• Prior stroke within the last 3 months
• Platelet count of below 100x103/mm3
• Blood glucose <50 or >400 mg/dl (<2.77 or >22.15 mmol/L)
• Known haemorrhagic diathesis
• Manifest or recent severe or dangerous bleeding
• Known bacterial endocarditis, pericarditis
• Acute pancreatitis
• Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal
varices, arterial-aneurysm, arterial/venous malformation
• Neoplasm with increased bleeding risk
• Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal
varices) and active hepatitis
• Major surgery or significant trauma in past 3 months
• Serious drug allergies
• Hypersensitivity to one of the components of the drug
• Severe renal impairment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified