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    Summary
    EudraCT Number:2017-000748-16
    Sponsor's Protocol Code Number:MT-2-01
    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:2020-12-15
    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 number2017-000748-16
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT
    EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF
    ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED
    ADRENOLEUKODYSTROPHY
    STUDIO MULTINAZIONALE, MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO DA PLACEBO, CON ESTENSIONE DI TRATTAMENTO IN APERTO PER
    VALUTARE L'EFFETTO DI MIN-102 SULLA PROGRESSIONE DELL'ADRENOMIELONEUROPATIA IN PAZIENTI DI SESSO MASCHILE AFFETTI DA ADRENOLEUCODISTROFIA LEGATA ALL'X
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate effect of MIN-102 compared to Placebo (sugar pill) after
    96 weeks of randomized, double-blind Treatment followed by open-label
    extension study to evaluate effect of long term treatment with MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients
    Studio per valutare l'effetto di MIN-102 paragonato al placebo dopo 96 settimane di trattamento randomizzato in doppio cieco seguito da uno studio di estensione in aperto per valutare l'effetto a lungo termine del trattamento con MIN-102 sulla progressione della adrenomieloneuropatia (AMN) in pazienti maschi
    A.3.2Name or abbreviated title of the trial where available
    ADVANCE
    ADVANCE
    A.4.1Sponsor's protocol code numberMT-2-01
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorMINORYX THERAPEUTICS
    B.1.3.4CountrySpain
    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 supportMinoryx Therapeutics S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMinoryx Therapeutics S.L.
    B.5.2Functional name of contact pointSilvia Pascual
    B.5.3 Address:
    B.5.3.1Street AddressAv. Ernest Lluch 32, TCM3
    B.5.3.2Town/ cityMatarò (Barcelona)
    B.5.3.3Post code08302
    B.5.3.4CountrySpain
    B.5.4Telephone number0034935441466
    B.5.5Fax number0034930160119
    B.5.6E-mailspascual@minoryx.com
    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 numberEU/3/16/1770
    D.3 Description of the IMP
    D.3.1Product name5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride
    D.3.2Product code MIN-102
    D.3.4Pharmaceutical form Oral suspension
    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 INN5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride
    D.3.9.1CAS number 146062-44-4
    D.3.9.2Current sponsor codeMIN-102
    D.3.9.4EV Substance CodeSUB16466MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 placeboOral suspension
    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
    ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY
    Adrenomieloneuropatia in pazienti maschi con adrenoleucodistrofia legata all'X
    E.1.1.1Medical condition in easily understood language
    ADRENOMYELONEUROPATHY
    Adrenomieloneuropatia
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10051260
    E.1.2Term Adrenoleukodystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main Study:
    Efficacy of MIN-102 on the progression of adrenomyeloneuropathy
    (AMN) in male patients as determined by the change from baseline in Six-Minute Walk Test (6MWT) compared with placebo after 96 weeks of treatment.
    Extension Study:
    To assess the safety and tolerability of MIN-102 upon long-term treatment.
    Studio Principale:
    Valutare l¿efficacia di MIN-102 sulla progressione dell¿adrenomieloneuropatia (AMN) in pazienti di sesso maschile sulla base della variazione dal basale nel test della distanza percorsa a piedi in 6 minuti (6MWT) rispetto a placebo dopo 96 settimane di trattamento.
    Studio di estensione:
    Valutare la sicurezza e la tollerabilit¿ di MIN-102 nel trattamento a lungo termine.
    E.2.2Secondary objectives of the trial
    Main Study:
    To evaluate the effects of MIN-102 after 96 weeks of treatment on:
    ¿ Change from baseline in body sway amplitude
    ¿ Comprehensive clinical rating scales (SSPROM and EDSS)
    ¿ Clinician and patient global impression of symptom severity and change
    ¿ Muscle strength
    ¿ Quality of life
    ¿ Incidence of cerebral inflammatory lesions.
    Safety objectives: To evaluate the safety and tolerability of MIN-102 compared with placebo
    Extension Study:
    To evaluate the long-term effects of MIN-102 on:
    ¿ Change from baseline in 6MWT and body sway
    ¿ Comprehensive clinical rating scales (SSPROM and EDSS)
    ¿ Quality of life
    ¿ Incidence of cerebral inflammatory lesions.
    Studio Principale:
    Valutare gli effetti di MIN-102 dopo 96 settimane di trattamento su:
    ¿ Variazione rispetto al basale dell¿ampiezza delle oscillazioni del corpo
    ¿ Scale di valutazione clinica completa (Sistema di valutazione della gravit¿ per la mielopatia progressiva [SSPROM] e Scala della disabilit¿ espansa [EDSS])
    ¿ Impressione globale del medico e del paziente sulla gravit¿ e sulla variazione dei sintomi
    ¿ Forza muscolare
    ¿ Qualit¿ di vita
    ¿ Incidenza di lesioni infiammatorie cerebrali.
    Obiettivi di Sicurezza: valutare la sicurezza e la tollerabilit¿ di MIN-102 paragonata al placebo
    Studio di estensione:
    Valutare gli effetti a lungo termine di MIN-102 su:
    ¿ Variazione rispetto al basale nel test 6MWT e nelle oscillazioni del corpo
    ¿ Scale di valutazione clinica completa (SSPROM e EDSS)
    ¿ Qualit¿ di vita
    ¿ Incidenza di lesion infiammatorie cerebrali
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Optional CSF Sampling Sub-Study and Optional Spinal Cord MRI scan
    Sub-study (integral part of Protocol Version 1.0 dated 26 Apr 2017)
    Objective:
    To evaluate the effects of MIN-102 on various biochemical markers in
    plasma and cerebrospinal fluid (CSF), and spinal cord imaging parameters.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sotto studio opzionale sul campionamento del liquido CerebroSpinale (CSF) e sotto studio opzionale sulle Risonaze Magnetiche del midollo spinale (parte integrale del protocollo versione 2.0 del 05 ottobre 2017).
    Obiettivi: valutare gli effetti di MIN-102 su diversi marker biochimici nel plasma e nel liquido cerebrospinale, ed I parametri d'immagini nel midollo spinale.
    Sotto studio ozpinale sulle scanzioni di risonanza magnetica del midollo spinale (parte integrale del protocollo versione
    2.0 del 05 ottobre 2017)
    Obiettivo: valutare gli effetti di MIN-102 sui parametri d'immagini del midollo spinale
    E.3Principal inclusion criteria
    Main Study:
    1. Male patients aged >=18 to <=65 years.
    2. Diagnosis of ALD based on elevated very long-chain fatty acids (VLCFA) and genetic testing
    3. Clinical evidence of spinal cord involvement, with an EDSS score between 2 and 6
    4. Ability to walk for 6 minutes, without or with rest, with usual walking aids (cane or walker)
    5. Ability to stand on a force plate with closed eyes and with feet apart for a minimum of 20 seconds
    6. Either a normal brain MRI or a type-1 through type-5 pattern MRI abnormality in which the abnormality does not show presence of inflammation.
    7. Normal adrenal function or appropriate steroid replacement if adrenal insufficiency is present.
    Extension Study:
    1. Completion of the entire 96-weeks double-blind period of the study (Part 1) and consent to participate in the extension study part.
    2. Normal adrenal function or appropriate steroid replacement
    3. Normal adrenal function or appropriate steroid replacement
    4.The following inclusion criteria of Part 1 will be modified:
    • age >=18 to <=65 years will no longer apply.
    • EDSS score between 2 and 6 will no longer apply.
    • Ability to walk for 6 minutes will no longer apply. If a patient is
    unable to walk for 6 minutes, the maximum time and walking distance
    will be recorded. If a patient is unable or refuses to walk at all, this will
    also be recorded.
    • Ability to stand on a force plate with eyes closed and feet apart for a
    minimum of 20 seconds will no longer apply. If a patient is no longer
    able to stand on a force plate for 20 seconds, this test will not be conducted.
    • Either a normal brain MRI or a or a type-1 through type-5 pattern MRI
    abnormality in which the abnormality does not show presence of
    inflammation (gadolinium enhancement) will no longer apply. In case of brain MRI lesions making the patient eligible for HSCT, he is still eligible for the extension study, but treatment will be discontinued
    immediately before any transplant-related treatment is initiated.
    A stable dose of Lorenzo´s Oil, botulinum toxin, N-acetylcysteine,
    baclofen, benzodiazepines, opiates and cannabis preparations,
    fampidrine and antioxidants will no longer apply.
    All other inclusion criteria of Part 1 remain in place.
    Studio Principale

    1. Pazienti di sesso maschile di età >=18 e <=65 anni.
    2. Diagnosi di ALD in base al livello elevato di acidi grassi a catena molto lunga (VLCFA) e ai test genetici.
    3. Evidenze cliniche di interessamento del midollo spinale con punteggio EDSS compreso tra 2 e 6.
    4. Capacità di camminare per 6 minuti, con o senza riposo, con gli abituali ausili alla locomozione (bastone o deambulatore).
    5. Capacità di rimanere in piedi su una pedana stabilometrica con gli occhi chiusi e i piedi separati per almeno 20 secondi.
    6. RM normale dell’encefalo o anomalia di tipo da 1 a 5 alla RM, in cui si ritenga che l’anomalia non mostri presenza di infiammazione.
    7. Funzione surrenale normale o adeguato sostituto steroideo in caso di insufficienza surrenalica.
    Studio di Estensione:
    1. Completamento dell’intero periodo in doppio cieco di 96 settimane dello studio (Parte 1) e consenso a partecipare alla partedi estensione dello studio
    2. Funzione surrenale normale o adeguato sostituto steroideo
    3. Funzione surrenalica normale o sostituzione steroidea appropriata
    4. Saranno modificati i seguenti criteri di inclusione della Parte 1:
    • Eliminata la necessità di età compresa tra >=18 e <=65 anni.
    • Eliminato il punteggio EDSS tra 2 e 6
    • Eliminata la capacità di camminare per 6 minuti. Se il paziente non è in grado di camminare per 6 minuti, saranno registrati il tempo massimo e la distanza percorsa. Se il paziente non è in grado o si rifiuta del tutto di camminare, anche questo sarà registrato.
    • Eliminata la capacità di stare in piedi su una placca di forza con occhi chiusi e piedi distanziati per minimo 20 secondi, Se il paziente non è in grado di stare in piedi sulla placca di forza per 20 secondi, il test non sarà condotto.
    • Eliminata la necessità di RM normale dell’encefalo o anomalia di tipo da 1 a 5 alla RM, in cui si ritenga
    che l’anomalia non mostri presenza di infiammazione (con gadolinio come mezzo di contrasto).
    apply.
    In caso di lesioni RM che rendono il paziente idoneo per HSCT, il paziente sarà sempre idoneo per lo
    studio di estensione, ma il trattamento sarà interrotto immediatamente prima dell’inizio di qualsiasi
    trattamento correlato al trapianto.
    Eliminato l'utilizzo di una dose stabile di Olio di Lorenzo, della tossina botulinica, della N-acetilcisteina, baclofene, benzodiazepine, oppiacei e preparati di cannabis, fampidrine e antiossidanti.
    Tutti gli altri criteri d'inclusione della Parte 1 restano applicabili
    E.4Principal exclusion criteria
    Main Study & Extension Study:
    1. Any other chronic neurological disease with signs of spastic paraplegia
    2. Known type 1 or type 2 diabetes.
    3. Known intolerance to pioglitazone or any other thiazolidinedione.
    4. Current treatment with immunosuppressant medication, except for corticosteroids.
    5. Previous or current history of cancer, bone marrow transplantation, Congestive heart failure, significant liver and renal disorders, anemia,
    pulmonary or cardiac diseases, Cognitive or behavioral abnormalities, alcohol/drug abuse etc.
    6. Reduced left-ventricular ejection fraction, or other clinically
    significant cardiac abnormalities on echocardiogram that in the
    investigator's opinion could predispose the subject to volume overload
    or its attendant consequences
    7. A positive result on laboratory tests for hepatitis B surface antigen,
    hepatitis C antibody and human immunodeficiency virus antibody.
    Studio Principale e di estensione:
    1. Eventuali altre malattie neurologiche croniche con segni di paraplegia spastica.
    2. Diabete di tipo 1 o 2 noto.
    3. Intolleranza nota a pioglitazone o a qualsiasi altro tiazolidinedione.
    4. Attuale trattamento con immunosoppressori, a eccezione dei corticosteroidi
    5. Anamnesi pregressa di cancro, trapianto di midollo osseo, insufficienza cardiac congestizia,
    malattie di fegato e reni significative, anemia, malattie polmonari o cardiache, anomalie cognitive o comportamentali, abuso di alcol/droghe ecc.
    6. Riduzione nella frazione di eiezione del ventricolo sinistro o altre anomalie cardiache clinicamente significative su ecocardiogramma che, secondo lo sperimentatore, potrebbero predisporre il soggetto ad un accumulo di volume o conseguenze.
    7. Risultato posivito nei test di laboratorio dell'antigene di superficie dell'Epatite B, Epatite C e anticorpi da virus di immunodeficienza umana.
    E.5 End points
    E.5.1Primary end point(s)
    Main Study:
    1. Efficacy: Change from baseline to week 96 in the total walking distance in the 6MWT
    Extension Study:
    1. Long-term safety and tolerability assessed in terms of AE, SAE,
    SUSARs, Vitals signs, ECG, Clinical Laboratory tests
    Studio Principale:
    1. Efficacia: modifiche rispetto al basale alla settimana 96 nella distanza di cammino totale nel 6MWT
    Studio di estensione:
    1. Sicurezza e tollerabilità a lungo termine valutata sugli Eventi Avversi, Eventi Avversi Seri, SUSAR, parametric vitali, ECG, test clinici di laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment period
    Durante il period di trattamento
    E.5.2Secondary end point(s)
    Main Study:
    1. Changes from baseline to week 96 in the following:
    ¿ Body sway amplitude
    ¿ Comprehensive clinical rating scales (SSPROM, EDSS)
    ¿ Clinician and patient global impression Scales (CGI-S, CGI-I, PGI-I)
    ¿ Dynamometry
    ¿ Quality of Life Assessments (EQ-5D-5L, MSWS-12, Qualiveen-SF and IIEF)
    ¿ Cerebral MRI (incidence of inflammatory lesions)
    2. Safety : Assessed in terms of AE, SAE, SUSARs, Vitals signs, ECG, Clinical Laboratory tests
    Extension Study:
    Changes from the baseline to the last scheduled on-study assessment for
    the following variables:
    ¿ 6MWT
    ¿ Body sway amplitude
    ¿ Comprehensive clinical rating scales (SSPROM, EDSS)
    ¿ Quality of Life Assessments (EQ-5D-5L, MSWS-12, Qualiveen-SF and IIEF)
    ¿ Cerebral MRI (incidence of inflammatory lesions)
    Studio Principale:
    1.variazioni rispetto al basale alla settimana 96 nei seguenti parametri: ¿ Ampiezza delle oscillazioni del corpo ¿ Scale di valutazione clinica (SSPROM, EDSS) ¿ Scale d'impressione globale dello sperimentatore e del paziente (CGI-S, CGI-I, PGI-I) ¿ Misure dinamometriche ¿ Valutazioni della qualit¿ della vita (EQ-5D-5L, MSWS-12, Qualiveen-SF and IIEF) ¿ RM dell¿encefalo (incidenza di lesioni infiammatorie cerebrali)
    2. Sicurezza: Valutazione in termini di AE, SAE, SUSARs, parametric vitali, ECG, test clinici di laboratorio
    Studio di Estensione: Variazioni rispetto al basale all'ultima valutazione prevista dallo studio per le valutazioni seguenti: ¿ 6MWT ¿ Ampiezza delle oscillazioni del corpo ¿ Scale di valutazione clinica (SSPROM, EDSS) ¿ Valutazioni della qualit¿ della vita (EQ-5D-5L, MSWS-12, Qualiveen-SF e IIEF) ¿ RM dell¿encefalo (incidenza di lesioni infiammatorie cerebrali)
    E.5.2.1Timepoint(s) of evaluation of this end point
    During treatment period
    Durante il period di trattamento
    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 Yes
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Lo studio principale ¿ randomizzato, controllato in doppio cieco. Lo studio di estensione ¿ in apert
    Main Study is Randomized, Controlled, Double-Blind and Extension Study is Open-Label
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    France
    Germany
    Hungary
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.1In 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: 105
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 105
    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)
    Extension study is intended to be continued for unlimited time until one of the termination criteria according to protocol is met
    Lo studio di estensione ¿ voluto per continuare il trattamento per un tempo illimitato fino a che uno dei criteri di conclusion descritti nel protocollo viene raggiunto
    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 Decision2017-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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