Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke (CERE-LYSE-1)

This study has been completed.
Sponsor:
Collaborator:
JSW-Research Forschungslabor GmbH, Parkring 12, 8074 Grambach
Information provided by:
Ever Neuro Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00840671
First received: February 9, 2009
Last updated: December 27, 2010
Last verified: December 2010
  Purpose

It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.


Condition Intervention Phase
Stroke
Drug: Cerebrolysin
Drug: 0.9% Saline Solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Placebo Controlled, Double Blind Trial About Safety and Efficacy of Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke

Resource links provided by NLM:


Further study details as provided by Ever Neuro Pharma GmbH:

Primary Outcome Measures:
  • Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NIH Stroke Scale Score 90 days after start of treatment (or earlier in the event of patient withdrawal). Actual score or change from baseline score analysed. [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
  • Glasgow Outcome Score 90 days after start of treatment (or earlier in the event of patient withdrawal). Actual score or change from baseline score analysed. [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
  • Barthel Index Score 90 days after start of treatment (or earlier in the event of patient withdrawal). Actual score or change from baseline score analysed. [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
  • Responders classified according to Barthel Index Score ≥95, Glasgow Outcome Score 0-1, NIHSS change from baseline score, 8 point improvement or total score 0-1 or NIHSS Distal Motor Function Score 0-1. Responder rates across each scale analysed. [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: October 2005
Study Completion Date: July 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cerebrolysin
Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Drug: Cerebrolysin
Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Placebo Comparator: 0.9% Saline Solution
0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Drug: 0.9% Saline Solution
0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Other Name: NaCl

Detailed Description:

The current trial should evaluate a combined treatment using Cerebrolysin immediately after thrombolysis to guarantee that the neurotrophic components are able to reach the endangered brain areas efficiently. An early start of treatment should guarantee rescue of most of the neurons reducing the overall damage.The study follows the design of pure thrombolytic trials to investigate, if the early neuroprotective treatment with Cerebrolysin is able to improve the overall outcome of patients at the day 90 evaluation visit. Due to the initial findings special emphasis will be also put on analysing the speed of recovery.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male inpatients.
  • Age: 18-80 years.
  • If female, patient must not be pregnant
  • Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze,vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes haemorrhage.
  • Onset of symptoms within 3 hours prior to initiation of rt-PA administration.
  • Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure or migraine disorder.
  • Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country.
  • Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtful that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. A written consent has to be obtained as soon as possible.
  • Willingness and ability to comply with the protocol.

Exclusion Criteria:

  • Evidence of intracranial haemorrhage (ICH) on the CT-scan
  • Violation of inclusion criteria not approved by clinical study director or study safety officer
  • 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
  • Lab values seriously abnormal, and/or more than 2 lab values abnormal not approved by clinical study director or study safety officer
  • Serious drug allergies
  • Hypersensitivity to one of the components of the drug
  • Severe renal impairment
  • Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits
  • Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture)
  • Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs, alcohol or industrial poisons
  • Symptoms of ischemic attack began more than 3 hours prior to start of thrombolytic therapy or if time of symptom onset is unknown
  • Minor neurological deficit or symptoms rapidly improving before start of infusion
  • Severe stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate imaging techniques
  • Epilepsy or epileptic seizure at onset of stroke
  • Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal
  • Known history of or suspected intracranial haemorrhage
  • Suspected subarachnoid haemorrhage or condition after subarachnoid hemorrhage from aneurysm
  • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
  • Haemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
  • Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
  • Patients receiving oral anticoagulants, e.g. warfarin sodium
  • Special attention should be given to possible additive effects when used in conjunction with anti-depressants or MAO-inhibitors
  • Cerebrolysin should not be mixed with balanced amino acid solutions in an infusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840671

Locations
Austria
Universitätsklinik Innsbruck, Dept. of Neurology
Innsbruck, Austria, 6020
LKH Klagenfurt, Abteilung für Neurologie
Klagenfurt, Austria, 9020
AKH Linz, Abteilung Neurologie & Psychiatrie
Linz, Austria, 4021
Außenstelle Landesklinikum Donauregion Gugging
Maria Gugging, Austria, 3400
Krankenhaus der Barmherzigen Brüder/Abteilung für Neurologie
Wien, Austria, 1020
Croatia
Klinicka Bolnicki Centar, Klinika za Nevrologiju
Rijeka, Croatia, 51000
Clinical Hospital Split, Dept. of Neurology
Split, Croatia, 21000
University Hospital Sorrores Misericoridae
Zagreb, Croatia, 10000
Medical School of Zagreb
Zagreb, Croatia, 10000
Czech Republic
St. Ann's Hospital, Dept. of Neurology
Brno, Czech Republic, 65691
Clinic of Neurology, Faculty Hospital Ostrava
Ostrava, Czech Republic, 70852
Blessed Mary Anthony Hospital, Dept. of Neurology
Ostrava Vitkovice, Czech Republic, 70384
University Hospital Plzen
Plzen, Czech Republic, 30460
Slovakia
University Hospital, Comenius University, Dept. of Neurology
Bratislava, Slovakia, 81369
Slovenia
Clinical Hospital Centre Ljubljana
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
Ever Neuro Pharma GmbH
JSW-Research Forschungslabor GmbH, Parkring 12, 8074 Grambach
Investigators
Study Director: Manfred Windisch, PhD JSW Research Forschungslabor GmbH
Principal Investigator: Wilfried Lang, MD Krankenhaus der Barmherzigen Brüder, 1020 Wien
  More Information

No publications provided by Ever Neuro Pharma GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Philipp Novak, EBEWE Neuro Pharma GmbH
ClinicalTrials.gov Identifier: NCT00840671     History of Changes
Other Study ID Numbers: CR040301, EudraCT-number: 2004-001729-11
Study First Received: February 9, 2009
Last Updated: December 27, 2010
Health Authority: Austria: Agency for Health and Food Safety
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Czech Republic: State Institute for Drug Control
Croatia: Agency for Medicinal Product and Medical Devices

Keywords provided by Ever Neuro Pharma GmbH:
Cerebrolysin
Alteplase
Ischemic Stroke
Modified Rankin Scale
NIH Stroke Scale
Barthel Index
Glasgow Outcome Score

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Cerebrolysin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Nootropic Agents
Central Nervous System Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014