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Summary
EudraCT Number:2004-001729-11
Sponsor's Protocol Code Number:CERE-LYSE-1 (CR040301)
National Competent Authority:Slovakia - SIDC (Slovak)
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2005-07-29
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 ConcernedSlovakia - SIDC (Slovak)
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(R) in acute ischemic hemispehric stroke
A.3.2Name or abbreviated title of the trial where available
CERE-LYSE-1
A.4.1Sponsor's protocol code numberCERE-LYSE-1 (CR040301)
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 GesmbH 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 Arzneimittel GmbH
D.2.1.2Country which granted the Marketing AuthorisationSlovakia
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.3.4Pharmaceutical 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. CT scan should exclude haemorrhage.
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
Assessment of 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
Male and female patients (18-80 years) with ischemic stroke not earlier then 3 hours before onset of thrombolytic treatment.
E.4Principal 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
E.5 End points
E.5.1Primary end point(s)
Modified Rankin Scale score at day 90 (or earlier in the event of withdrawal).
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
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 Yes
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 years1
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years2
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 2005-07-29. 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 state16
F.4.2 For a multinational trial
F.4.2.1In the EEA 96
F.4.2.2In the whole clinical trial 108
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 Decision2005-10-19
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-10-19
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2008-07-01

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