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    Summary
    EudraCT Number:2011-001329-26
    Sponsor's Protocol Code Number:EPOSS2010
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-11-17
    Trial 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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-001329-26
    A.3Full title of the trial
    ErythroPOietin in ALS: a Study of dose-finding and Safety
    Eritropoietina nella SLA: uno studio di identificazione della dose e sicurezza
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Erythropoietin in Amyotrophic Lateral Sclerosis: a study to identify the best dose and the optimal route of administration and evaluate the safety
    Eritropoietina nella Sclerosi Laterale Amiotrofica: uno studio per identificare la dose e la via di somministrazione ottiminali e valutarne la sicurezza
    A.3.2Name or abbreviated title of the trial where available
    EPOSS2010
    EPOSS2010
    A.4.1Sponsor's protocol code numberEPOSS2010
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorISTITUTO NEUROLOGICO "CARLO BESTA"
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportARISLA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Neurologico Carlo Besta
    B.5.2Functional name of contact pointServizio Ricerca e Sviluppo Clinico
    B.5.3 Address:
    B.5.3.1Street AddressVia Celoria, 11
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number02/23942321
    B.5.5Fax number02/23943569
    B.5.6E-mailcrc@istituto-besta.it
    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 Yes
    D.2.1.1.1Trade name EPREX*1SIR 40000UI/ML 1ML
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN CILAG SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERYTHROPOIETIN
    D.3.9.1CAS number 11096-26-7
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40000
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amyotrophic Lateral Sclerosis
    Sclerosi Laterale Amiotrofica
    E.1.1.1Medical condition in easily understood language
    Degenerative motoneuron disease
    Malattia degenerativa dei motoneuroni
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The project aims to assess: 1) safety and tolerability of rhEPO given at different doses and by different routes; 2) modulation of potential biomarkers involved in the neuroprotective activity of EPO; 3) percentage of rhEPO crossing the BBB in ALS patients. Since ALS patients are at risk for some events included in the primary outcome (e.g. venous thrombosis), a placebo arm will be included.
    Il progetto mira a valutare: 1) la sicurezza e la tollerabilità di rhEPO somministrato a dosi diverse e per vie diverse, 2) modulazione dei biomarcatori potenzialmente coinvolte nell'attività neuroprotettivo di EPO, 3) la percentuale di rhEPO che attraversano la BBB nei pazienti con SLA. Poiché i pazienti SLA sono a rischio per alcuni eventi inclusi nel outcome primario (trombosi venosa), un braccio placebo saranno inclusi.
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability of rhEPO administered iv for 4 months or sc open in 60 patients with ALS. Patients will be treated fortnightly with 120,000, 80,000, or 40,000 IU / ml. Safety will be analyzed in relation to adverse events associated with the erythropoietic activity of rhEPO and compared to the placebo arm. Biomarkers will be investigated including EPCs, VEGF and rhEPO modulated by NO. It will assess the percentage of rhEPO through the BBB.
    Valutare sicurezza e tollerabilità di rhEPO somministrata per 4 mesi i.v. o s.c. in aperto in 60 pazienti affetti da SLA. I pazienti saranno trattati quindicinalmente con 120.000, 80.000, o 40.000 Ul/ml. La sicurezza sarà analizzata in relazione agli eventi avversi connessi con l'attività eritropoietica di rhEPO e rispetto al braccio placebo. Saranno indagati biomarcatori tra cui EPC, VEGF e NO modulati da rhEPO. Si valuterà la percentuale di rhEPO che attraversa la BBB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    STUDY POPULATION: 60 patients with diagnosis of laboratory-supported probable, probable, or definite ALS according to El Escorial revised criteria. PATIENTE ELIGIBILITY: 1. age 18-75 years 2. diagnosis of sporadic or familial ALS 3. onset of weakness <=36 months prior enrolment 4. willingness to undergo active contraception (excluding estroprogestinic drugs) for fertile female subjects throughout the entire study period 5. written informed consent. All patients will be required to take riluzole 100 mg daily and patients will be considered eligible if on stable dose for at least 60 days. Not following riluzole for any reason (e.g.side effects,etc.) will not be considered an exclusion criteria. Patients on riluzole at the randomization will be asked to remain on stable dose for the whole study. Patients not on riluzole will not take it for the entire study period
    Popolazione in studio: 60 pazienti con diagnosi di SLA probabile, probabile supportata da laboratorio o definita secondo i criteri di El Escorial rivisti. CRITERI DI ELEGGIBILITA: 1. età 18-75 anni 2. diagnosi di SLA sporadica o familiare 3. insorgenza &lt;= 36 mesi 4. volontà di sottoporsi a contraccezione attivi (esclusi farmaci estroprogestinic) per i soggetti di sesso femminile fertile per tutto il periodo di studi 5. consenso informato scritto. A tutti i pazienti sarà richiesto di assumere riluzolo 100 mg/die. La non assunzione per qualsiasi motivo (es effetti collaterali) non sarà considerato criterio di esclusione.
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA: 1. hematocrit >49% in men and >47% in women, hemoglobin value >15 g/dl in men and >13 g/dl in women 2. tracheotomy 3. clinical diagnosis of frontotemporal dementia, Parkinson or Alzheimer disease 5. history and/or instrumental evidence of previous myocardial infarction or thrombotic vascular events (such as stroke, transient ischemic attack, pulmonary emboli, retinal thrombosis, deep vein or arterial thrombosis including asymptomatic carotid and/or vertebral stenosis >30%) 6. clinically evident cardiac disease (ischemic heart disease, congestive heart failure, arrhythmia) 7. uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >95 mmHg irrespective of anti-hypertensive treatments at two consecutive evaluations) 8. active malignancy, polycythemia, myeloproliferative disorders 9. hypercoagulable disorders (ref. Deitcher S, in Current Clinical Medicine 2009, Cleveland Clinic ed., Elsevier) 10. porphyria 11. known hypersensitivity to human albumin 12. female subjects pregnant or lactating 13. use of post-menopausal drugs (estrogen, progestinic, or their combination) 14. use of hormonal contraception drugs 15. use of experimental drug or participation in a clinical trial within 3 months prior to screening 16. previous treatment with hematopoietic stem cells
    Criteri di esclusione: 1. ematocrito&gt; 49% negli uomini e&gt; 47% nelle donne, il valore di emoglobina&gt; 15 g / dl negli uomini e&gt; 13 g / dl nelle donne 2. tracheotomia 3. diagnosi clinica di demenza frontotemporale, il Parkinson o la malattia di Alzheimer 5. storia e / o evidenze strumentali di precedente infarto miocardico o eventi trombotici vascolari (come ictus, attacco ischemico transitorio, embolia polmonare, trombosi retinica, trombosi venosa profonda o arteriosa compresa carotidea asintomatica e / o stenosi vertebrale&gt; 30%) 6. clinicamente evidente malattia cardiaca (cardiopatia ischemica, scompenso cardiaco congestizio, aritmie) 7. ipertensione non controllata (pressione sistolica&gt; 160 mmHg e pressione diastolica&gt; 95 mmHg a prescindere dal trattamento antipertensivo a due valutazioni consecutive) 8. tumore maligno in atto, policitemia, malattie mieloproliferative 9. Disturbi di ipercoagulabilità (rif. Deitcher S, in corrente Medicina Clinica 2009, Cleveland Clinic ed., Elsevier) 10. porfiria 11. ipersensibilità nota alla albumina umana 12. soggetti di sesso femminile in gravidanza o allattamento 13. uso di farmaci post-menopausa (estrogeni, progestinici, o loro combinazione) 14. uso di farmaci contraccettivi ormonali 15. uso del farmaco sperimentale o la partecipazione ad un trial clinico nei 3 mesi precedenti allo screening 16. precedente trattamento con cellule staminali ematopoietiche
    E.5 End points
    E.5.1Primary end point(s)
    Discontinuation of treatment because of hematocrit or haemoglobin values, adverse events, or death
    L'interruzione del trattamento a causa di valori di ematocrito o emoglobina, gli eventi avversi, o morte
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 months
    4 mesi
    E.5.2Secondary end point(s)
    Changes in biomarkers analyzed between treatment groups
    Variazioni dei biomarkers analizzati tra gruppi di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 months
    4 mesi
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial7
    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.8.4.1Number of sites anticipated in Member State concerned2
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    CLINICAL FOLLOW-UP PLANNED PROGRAM (FIRST VISIT TO 1 MONTH AFTER THE END OF THE STUDY, AFTER EVERY 3 MONTHS)
    PROSECUZIONE DEI CONTROLLLI CLINICI DI FOLLOW-UP CON PROGRAMMAZIONE PIANIFICATA (PRIMA VISITA 1 MESE DOPO IL TERMINE DELLO STUDIO, SUCCESSIVE OGNI 3 MESI)
    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 Decision2011-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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