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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43693   clinical trials with a EudraCT protocol, of which   7245   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2015-003147-19
    Sponsor's Protocol Code Number:BECRO/MINERALstudy
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-05-25
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2015-003147-19
    A.3Full title of the trial
    Novel Oral Nutraceutical Intervention NEUROASPIS PLP10® for the Treatment of Relapsing-Remitting Multiple Sclerosis: A Multicenter, Parallel-group, Phase III, Double-blind, Randomized, Placebo-Controlled, Add-on with Interferon Beta, Trial of Efficacy and Safety.
    Νέα Διατροφική Παρέμβαση με Πόσιμο NEUROASPIS PLP10® για τη θεραπεία της Υποτροπιάζουσας-Διαλείπουσας Πολλαπλής Σκλήρυνσης: Πολυκεντρική, Παράλληλων ομάδων, Φάσης ΙΙΙ, Διπλή-Τυφλή, Τυχαιοποιημένη, Ελεγχόμενη με εικονικό φάρμακο, σε συνδυασμό με ιντερφερόνη βήτα, Δοκιμή Αποτελεσματικότητας και Ασφάλειας
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS).
    Να επιβεβαιωθεί η ασφάλεια και η αποτελεσματικότητα του NEUROASPIS PLP10® στη θεραπεία των ατόμων που έχουν διαγνωστεί με υποτροπιάζουσα-διαλείπουσα πολλαπλή σκλήρυνση (MS).
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety study of NEUROASPIS PLP10® versus placebo
    Mελέτη Αποτελεσματικότητας και Ασφάλειας του NEUROASPIS PLP10® έναντι εικονικού φαρμάκου
    A.4.1Sponsor's protocol code numberBECRO/MINERALstudy
    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 SponsorPALUPA Medical Ltd
    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 supportPALUPA Medical Ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBECRO
    B.5.2Functional name of contact pointCLINICAL TRIAL INFORMATION
    B.5.3 Address:
    B.5.3.1Street AddressEftalioti 21,Neo Psychiko
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code11525
    B.5.4Telephone number+302106729037
    B.5.5Fax number+302106729037
    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 No
    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 nameNEUROASPIS PLP10®
    D.3.4Pharmaceutical form Oral liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameFISH OIL, RICH IN OMEGA-3-ACIDS
    D.3.9.4EV Substance CodeSUB90503
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number42.1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBORAGE OIL 20% GLA
    D.3.9.1CAS number 8000051-62-9
    D.3.9.3Other descriptive nameBORAGE OIL
    D.3.9.4EV Substance CodeSUB13111MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number43.7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbeta-Carotene
    D.3.9.3Other descriptive nameBETACAROTENE
    D.3.9.4EV Substance CodeSUB05791MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.04
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGamma-tocopherol
    D.3.9.1CAS number 54 28 4
    D.3.9.4EV Substance CodeSUB42464
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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. medicinal product typeNEUROASPIS PLP10® oral solution, is a combination product of Fish oil Rich in Omega-3-acids (EPA/DHA), Borage oil 20% GLA (LA/GLA) , vitamin A, vitamin E as alpha- and gamma-tocopherol.
    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 placeboOral liquid
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing-Remitting Multiple Sclerosis (RRMS)
    Υποτροπιάζουσα-Διαλείπουσα Πολλαπλή Σκλήρυνση
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis (MS) is an inflammatory disease that destroys the myelin in the central nervous system causing neurological disorders and often severe disability.
    H σκλήρυνση κατά πλάκας είναι μια φλεγμονώδης πάθηση που καταστρέφει την μυελίνη του κεντρικού νευρικού συστήματος και προκαλεί νευρολογικές διαταραχές και, συχνά, σοβαρή αναπηρία.
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS)
    Να επιβεβαιωθεί η ασφάλεια και η αποτελεσματικότητα του NEUROASPIS PLP10® στη θεραπεία των ατόμων που έχουν διαγνωστεί με Υποτροπιάζουσα-Διαλείπουσα Πολλαπλή Σκλήρυνση [(RR) MS]
    E.2.2Secondary objectives of the trial
    Not applicable
    Δεν εφαρμόζεται
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women.
    • Ages of between 18 and 55 years.
    • Diagnosis of relapsing remitting Multiple Sclerosis (RRMS) according to revised McDonald criteria.
    • A score of 0.0 to 5.0 on the Expanded Disability Status Scale (EDSS).
    • At least one medically documented relapse within the 18 months before enrolment.
    • Cranial MRI scan demonstrating lesion(s) consistent with MS.
    • On Interferon beta (IFN-β) treatment for the last 6 continuous months or more.
    • Άντρες και γυναίκες.
    • Ηλικίες μεταξύ 18 και 55 χρόνων.
    • Διάγνωση υποτροπιάζουσας-διαλείπουσας πολλαπλής Σκλήρυνσης σύμφωνα με τα αναθεωρημένα Κριτήρια McDonald.
    • Με βαθμολογία από 0.0 μέχρι 5.0 στην Διευρυμένη Κλίμακα Κατάστασης Αναπηρίας (EDSS).
    • Μια τουλάχιστον ιατρικώς καταγεγραμμένη υποτροπή μέσα στους 18 μήνες πριν από την εγγραφή.
    • Μαγνητική Τομογραφία Εγκεφάλου που να αποδεικνύει αλλοίωση (-εις) σχετική με την πολλαπλή σκλήρυνση.
    • Σε θεραπεία με Ιντερφερόνη-βήτα (IFN-β) για τους τελευταίους 6 συνεχόμενους μήνες η περισσότερο.
    E.4Principal exclusion criteria
    • Prior immunosuppressants or monoclonal antibodies therapy (prior or concomitant use of cladribine, mitoxantrone, copaxone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, fingolimod or natalizumab (Tysabri), Tecfidera/BG-12).
    • Prior use in the 3 months preceding randomization, of cytokine therapy, glatiramer acetate or intravenous immunoglobulins, or concomitant use of these treatments.
    • Consumption of any additional food supplement formula (prior use in the 3 months preceding randomization, of any type of vitamin including vitamin D, or 6 months preceding randomization, of any form of polyunsaturated fatty acid (PUFA), or concomitant use of these treatments).
    • Prior or concomitant use of Statins.
    • Pregnancy or nursing.
    • A clinically significant infectious illness within 30 days prior to randomization.
    • Primary progressive, secondary progressive or progressive relapsing MS.
    • Patients known to have a history of recent drug or alcohol abuse.
    • Any severe disease other than MS compromising organ function, meaning: history of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of NEUROASPIS PLP10® for 30 months.
    • History of severe allergic or anaphylactic reactions or known specific nutritional hypersensitivity.

    During on intervention treatment it is strongly suggested for the patients to continue only on the interferon beta treatment. If a patient changes therapy to immunosuppressant or monoclonal antibody or fingolimode or any other treatment on physicians’ decision then he/she will be considered as a drop-out; but continue to be medically followed for the intention to treat analyses purposes.
    • Προηγούμενη θεραπεία με ανοσοκατασταλτικά ή μονοκλωνικά αντισώματα (προηγούμενη ή ταυτόχρονη χρήση κλαδριβίνης, μιτοξαντρόνης, copaxone, ή άλλα ανοσοκατασταλτικά φάρμακα όπως η αζαθειοπρίνη, η κυκλοφωσφαμίδη, η κυκλοσπορίνη, μεθοτρεξάτη, μυκοφαινολάτη, φινγκολιμόδη ή natalizumab (Tysabri), Tecfidera / BG - 12 ).
    • Προηγούμενη χρήση εντός των 3 μηνών πριν από την τυχαιοποίηση, θεραπείας κυτοκίνης, οξικής γλατιραμέρης ή ενδοφλέβιων ανοσοσφαιρινών, ή ταυτόχρονη χρήση αυτών των θεραπειών.
    • Η κατανάλωση οποιουδήποτε πρόσθετου τύπου συμπληρώματος διατροφής (προηγούμενη χρήση εντός των 3 μηνών πριν από την τυχαιοποίηση οποιουδήποτε είδους βιταμίνης, συμπεριλαμβανομένης της βιταμίνης D, ή 6 μήνες πριν από την τυχαιοποίηση, χρήση οποιασδήποτε μορφής πολυακόρεστων λιπαρών οξέων (PUFA), ή ταυτόχρονη χρήση αυτών).
    • Προηγούμενη ή ταυτόχρονη χρήση στατινών.
    • Κύηση η γαλουχία.
    • Μια κλινικά σημαντική μολυσματική ασθένεια εντός 30 ημερών πριν από την τυχαιοποίηση.
    • Πρωτοπαθής προϊούσα, δευτερογενώς προϊούσα ή προϊούσα υποτροπιάζουσα πολλαπλή σκλήρυνση.
    • Ασθενείς που έχουν ιστορικό πρόσφατης χρήσης αλκοόλ ή ναρκωτικών.
    • Οποιαδήποτε σοβαρή ασθένεια, εκτός της πολλαπλής σκλήρυνσης που να θέτει σε κίνδυνο τη λειτουργία οργάνων, εννοώντας: ιστορικό μη φυσιολογικών εργαστηριακών αποτελεσμάτων που να αποδεικνύουν μια σημαντική καρδιακή, ενδοκρινολογική, αιματολογική, ηπατική, ανοσολογική, μεταβολική, ουρολογική, πνευμονική, γαστρεντερική, δερματολογική, νεφρική ή/άλλη σημαντική ασθένεια, που κατά τη γνώμη του ερευνητή θα απέκλειε τη χορήγηση του NEUROASPIS PLP10® για 30 μήνες.
    • Ιστορικό σοβαρών αλλεργικών ή αναφυλακτικών αντιδράσεων ή γνωστές συγκεκριμένες διατροφικές υπερευαισθησίες.
    Κατά τη διάρκεια της παρεμβατικής θεραπείας συνιστάται επιτακτικά στους ασθενείς να συνεχίσουν μόνο με θεραπεία με ιντερφερόνη-βήτα. Εάν ο ασθενής κάνει αλλαγή θεραπείας σε θεραπεία με ανοσοκατασταλτικά ή μονοκλωνικά αντίσωμα ή fingolimode ή σε οποιαδήποτε άλλη θεραπεία με απόφαση του γιατρού τότε αυτός/αυτή θα αποσύρεται από τη μελέτη, αλλά θα συνεχίζει να παρακολουθείτε ιατρικά με σκοπό να εξυπηρετήσει τους σκοπούς της ανάλυσης.
    E.5 End points
    E.5.1Primary end point(s)
    Annual relapse rate (ARR)
    Ετήσιος ρυθμός υποτροπών (ARR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At enrolment, at entry baseline and at 6, 12, 18 and 24 (total 30 months including normalization) months on-treatment as well as at 6 months after the end of the study to confirm final EDSS score.Relapses will be evaluated and confirmed at any time they appear.
    Στην ένταξη, 6 μήνες μετά την ένταξη και στους 6, 12, 18 και 24 μήνες καθώς και στους 6 μήνες μετά το τέλος της μελέτης για να επιβεβαιωθεί η τελική βαθμολογία στην κλίμακα EDSS. Οι υποτροπές θα αξιολογηθούν οιαδήποτε χρονική στιγμή εμφανισθούν
    E.5.2Secondary end point(s)
    1. Time to confirmed disability progression.
    2. The number of new or enlarging brain lesions (evaluated by MRI).
    3. Quantity changes of inflammatory/anti-inflammatory markers in the blood.
    1. Χρονική επιβεβαίωση της εξέλιξη της αναπηρίας.
    2. Εγκεφαλικές αλλοιώσεις (αξιολογούμενες από Μαγνητικό Τομογράφο Εγκεφάλου).
    3. Φλεγμονώδεις/αντιφλεγμονώδεις δείκτες στο αίμα.

    E.5.2.1Timepoint(s) of evaluation of this end point
    1.At baseline, after 6 months for the confirmation, 6 months after the end of the study
    2. At enrollment and at 24 months
    3. at enrollment, baseline, 12 and 24-months
    1. Στην ένταξη, 6 μήνες μετά για επιβεβαίωση, 6 μήνες μετά την λήξη της μελέτης.
    2. Στην ένταξη και στους 24 μήνες
    3. Στην ένταξη, στην έναρξη ( baseline) και στους 12 και 24 μήνες
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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. 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.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Yes
    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 years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 220
    F.1.3Elderly (>=65 years) No
    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 state165
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 220
    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)
    Patients will be followed during 12 month washout period (post study)
    Οι ασθενείς θα συνεχίσουν να παρακολουθούνται για περίοδο 12 μηνών έκπλυσης μετά το τέλος της μελέτης
    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 Decision2016-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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