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Summary
EudraCT Number:2004-001729-11
Sponsor's Protocol Code Number:CR040301
National Competent Authority:Austria - BASG
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2005-01-14
Trial results View results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedAustria - BASG
A.2EudraCT number2004-001729-11
A.3Full title of the trial
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
A.3.2Name or abbreviated title of the trial where available
CERE-LYSE-1
A.4.1Sponsor's protocol code numberCR040301
A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorEBEWE Pharma Ges.m.b.H Nfg.KG
B.1.3.4CountryAustria
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Cerebrolysin
D.2.1.1.2Name of the Marketing Authorisation holderEBEWE Pharma Ges.m.b.H Nfg. KG
D.2.1.2Country which granted the Marketing AuthorisationAustria
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameCerebrolysin
D.3.2Product code N/A
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Yes
D.3.11.13.1Other medicinal product typeproteolytic peptide preparation
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboSolution for infusion
D.8.4Route of administration of the placeboIntravenous use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
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 characterised 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
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 6.0
E.1.2Level LLT
E.1.2Classification code 10055221
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To assess efficacy and safety of the combined treatment with rt-PA (max. 3 hours after stroke) and the neuroprotective/neurotrophic drug Cerebrolysin
E.2.2Secondary objectives of the trial
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal 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 characterised 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 generalised 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 authorised 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 undoubtfully 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.
E.4Principal 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
E.5 End points
E.5.1Primary end point(s)
Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal)
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial has a data monitoring committee Information not present in EudraCT
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months12
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial months12
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-01-14. Yes
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation Yes
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state36
F.4.2 For a multinational trial
F.4.2.1In the EEA 36
F.4.2.2In the whole clinical trial 108
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
The investigator has the responsibility to report Adverse Events occurring within 4 weeks after a subject completes the trial, as defined and described in the “Adverse Event Reporting" section of the Investigator’s File.
All Adverse Events, including those persisting after hospital discharge, must be followed up until either complete recovery occurs or the event has been adequately characterised.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2005-02-18
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-02-18
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2008-03-07

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