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    Summary
    EudraCT Number:2018-000506-34
    Sponsor's Protocol Code Number:EMERA006
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-09
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2018-000506-34
    A.3Full title of the trial
    EMERA006- A pilot, exploratory, randomised, placebo-controlled, double blinded, cross-over, Phase 2a study to explore efficacy and safety of NBMI treatment in patients with Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA).
    EMERA006 -Pilotno, exploratorno, randomizirano, dvojno slepo, s placebom kontrolirano navzkrižno klinično preskušanje faze 2 a zdravljenja za oceno učinkovitosti in varnosti NBMI pri bolnikih s PSP ali MSA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EMERA006 - A pilot, exploratory, randomised, placebo-controlled, double blinded, cross-over, Phase 2a study to explore efficacy and safety of NBMI treatment in patients with Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA).
    EMERA006 -Pilotno, exploratorno, randomizirano, dvojno slepo, s placebom kontrolirano navzkrižno klinično preskušanje faze 2 a zdravljenja za oceno učinkovitosti in varnosti NBMI pri bolnikih s PSP ali MSA.
    A.3.2Name or abbreviated title of the trial where available
    EMERA006
    A.4.1Sponsor's protocol code numberEMERA006
    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 SponsorNBMI Science Ltd.
    B.1.3.4CountryIreland
    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 supportNBMI Science Ltd
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRS d.o.o.
    B.5.2Functional name of contact pointTanja Turk
    B.5.3 Address:
    B.5.3.1Street AddressUkmarjeva ulica 6
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number+38615442501
    B.5.5Fax number+38615442502
    B.5.6E-mailtanja.turk@crs.si
    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 Yes
    D.2.5.1Orphan drug designation numberMercury toxicity
    D.3 Description of the IMP
    D.3.1Product nameNBMI
    D.3.2Product code NBMI
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNemeramide
    D.3.9.1CAS number 100-00-5
    D.3.9.2Current sponsor codeNBMI
    D.3.9.3Other descriptive nameN1,N3-BIS(2-MERCAPTOETHYL) ISOPHTHALAMIDE
    D.3.9.4EV Substance CodeSUB184226
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 No
    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 placeboCapsule, hard
    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
    PSP or MSA
    PSP ali MSA
    E.1.1.1Medical condition in easily understood language
    PSP or MSA
    PSP ali MSA
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study is an exploratory pilot study. Thus no formal sample size calculation or hypothesis testing will be done.

    Main objective is to investigate the efficacy of 28 days NBMI treatment on motor and non-motor symptoms and heath related quality of life in patients with Progressive Supranuclear Palsy or Multiple Systems Atrophy disease.
    Študija je exploratorna pilotska študija.
    Evaluirati učinkovitost zdravljenja z NBMI na motorične in nemotorične simtope ter z zdravjem povezano kakovost življenja bolnikov s progresivno supranuklearno paralizo (PSP) ali multiplo sistemsko atrofijo (MSA)
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of 28 days oral administration of NBMI in patients with PSP or MSA.
    To investigate the efficacy of NBMI daily oral administration for 28 days on fatigue in MSA and PSP patients.
    To investigate the efficacy of NBMI daily oral administration for 28 days on depression in MSA and PSP patients.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FDG PET imaging substudy.
    Objective is to explore changes from baseline in brain metabolism as evaluated with FDG- PET- CT brain imaging, compared to placebo treatment Pharmacokinetic parameters derived from plasma concentration of NBMI in patients with PSP or MSA.
    E.3Principal inclusion criteria
    1. Patient has clinically confirmed diagnosis of PSP or MSA according to the current criteria.
    2. Patient has a brain MRI finding consistent with diagnosis of PSP or MSA at screening
    3. Patient is aged 50 years to 85 years inclusive at screening age.
    4. Patient is on stable therapy for PSP or MSA for at least 1 month prior to screening visit.
    5. If patient received i.v amantadine treatment, the last infusion must have been administered at least 6 months prior to the screening.
    E.4Principal exclusion criteria
    1. Known hystory or presence of clinically significant other neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric or cardiovascular disease or other condition which in opinion of investigators would jeapardise the safety of the subject or impact the validity of study results.
    2. Known or suspected hypesensitivity or idiosyncratic reaction to NBMI or any other drug substance with similar activity
    3. Patient has known contraindication for MRI imaging
    E.5 End points
    E.5.1Primary end point(s)
    Changes from baseline in motor and non-motor symptoms and heath related quality of life in patients with Progressive supranuclear palsy or Multiple Ssystems atrophy disease compared to placebo treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Mean change in PSPRS and FAB individual scales scores from Baseline - V1 to V2 (D29) and V4 (D57) in PSP patients. and mean change in UMSARS
    and NMSS individual scales scores Baseline - V1 to V2 (D29) and V4 (D57) in MSA patients
    Changes in QOL individual scores from baseline by MSA questionnaire in MSA patients and in EQ-5D score in PSP patients compared to placebo
    treatment - V1 to V2 (D29) and V4 (D57)
    E.5.2Secondary end point(s)
    Adverse events in terms of frequency and severity compared to placebo treatment
    Changes from baseline in fatigue as measured by PFS in MSA and PSP patients compared to placebo treatment ,
    Changes from baseline in depression as measured by Beck’s Depression Inventory in MSA patients and GDS in PSP patients compared to placebo treatment .

    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events in terms of frequency and severity compared to placebo treatment - during the whole study.
    Changes Mean change in PFS score from Baseline - V1 to V2 (D29) and V1 to V4 (D57) in PSP and MSA patient.s compared to placebo treatment
    Changes in BDI scale (MSA patients) and GDS scale (PSP patients) score from Baseline - V1 to V2 (D29) and to V4 (D57) compared to placebo
    treatment ).

    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory endopoints.
    Raziskovalne končne točke.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LSLV
    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 months9
    E.8.9.1In the Member State concerned days0
    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) No
    F.1.2.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Participation in Phase II b trial will be considered.
    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 Decision2019-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-30
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