- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00840671
Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke (CERE-LYSE-1)
December 27, 2010 updated by: Ever Neuro Pharma GmbH
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Innsbruck, Austria, 6020
- Universitätsklinik Innsbruck, Dept. of Neurology
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Klagenfurt, Austria, 9020
- LKH Klagenfurt, Abteilung für Neurologie
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Linz, Austria, 4021
- AKH Linz, Abteilung Neurologie & Psychiatrie
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Maria Gugging, Austria, 3400
- Außenstelle Landesklinikum Donauregion Gugging
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Wien, Austria, 1020
- Krankenhaus der Barmherzigen Brüder/Abteilung für Neurologie
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Rijeka, Croatia, 51000
- Klinicka Bolnicki Centar, Klinika za Nevrologiju
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Split, Croatia, 21000
- Clinical Hospital Split, Dept. of Neurology
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Zagreb, Croatia, 10000
- Medical School of Zagreb
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Zagreb, Croatia, 10000
- University Hospital Sorrores Misericoridae
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Brno, Czech Republic, 65691
- St. Ann's Hospital, Dept. of Neurology
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Ostrava, Czech Republic, 70852
- Clinic of Neurology, Faculty Hospital Ostrava
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Ostrava Vitkovice, Czech Republic, 70384
- Blessed Mary Anthony Hospital, Dept. of Neurology
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Plzen, Czech Republic, 30460
- University Hospital Plzen
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Bratislava, Slovakia, 81369
- University Hospital, Comenius University, Dept. of Neurology
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Ljubljana, Slovenia, 1525
- Clinical Hospital Centre Ljubljana
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cerebrolysin
Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy.
Daily infusion for 10 consecutive days.
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Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy.
Daily infusion for 10 consecutive days.
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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.
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0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy.
Daily infusion for 10 consecutive days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal).
Time Frame: Day 90
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Day 90
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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90 days after start of treatment
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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
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90 days after start of treatment
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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
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90 days after start of treatment
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Manfred Windisch, PhD, JSW Research Forschungslabor GmbH
- Principal Investigator: Wilfried Lang, MD, Krankenhaus der Barmherzigen Brüder, 1020 Wien
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
February 9, 2009
First Submitted That Met QC Criteria
February 9, 2009
First Posted (Estimate)
February 10, 2009
Study Record Updates
Last Update Posted (Estimate)
December 28, 2010
Last Update Submitted That Met QC Criteria
December 27, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR040301
- EudraCT-number: 2004-001729-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Mansoura University Children HospitalCompletedCerebral Palsy | Infant Development | Preterm InfantEgypt
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Clinical Institute of the Brain, RussiaEver Neuro Pharma GmbH; Nycomed; VeropharmCompleted
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