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    Summary
    EudraCT Number:2015-002586-39
    Sponsor's Protocol Code Number:MC-TER.2/SSc
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2018-02-06
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002586-39
    A.3Full title of the trial
    Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to
    Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy
    in Subjects With Diffuse Cutaneous Systemic Sclerosis
    Studio randomizzato, multicentrico, in doppio cieco, controllato con placebo per valutare la sicurezza e l’efficacia di Terguride in aggiunta a terapia sintomatica in soggetti affetti da sclerosi sistemica cutanea diffusa (TERGISS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis
    Terguride in aggiunta a terapia sintomatica in soggetti affetti da sclerosi sistemica cutanea diffusa
    A.3.2Name or abbreviated title of the trial where available
    Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis
    Terguride in aggiunta a terapia sintomatica in soggetti affetti da sclerosi sistemica cutanea diffus
    A.4.1Sponsor's protocol code numberMC-TER.2/SSc
    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 SponsorMEDAC GMBH
    B.1.3.4CountryGermany
    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 supportmedac GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationmedac GmbH
    B.5.2Functional name of contact pointProject Manager Clinical Research
    B.5.3 Address:
    B.5.3.1Street AddressTheaterstrasse 6
    B.5.3.2Town/ cityWedel
    B.5.3.3Post codeD 22880
    B.5.3.4CountryGermany
    B.5.4Telephone number4941038006434
    B.5.5Fax number4941038006422
    B.5.6E-mailc.guimbal-schmolck@medac.de
    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 numberEMA/OD/153/12
    D.3 Description of the IMP
    D.3.1Product nameTerguride
    D.3.2Product code /
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERGURIDE HYDROGENMALEATE
    D.3.9.1CAS number 37686-85-4
    D.3.9.2Current sponsor code/
    D.3.9.4EV Substance CodeSUB04725MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 Yes
    D.3.11.13.1Other medicinal product typeAlcaloide dell'ergot semisintetico
    D.IMP: 2
    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 numberEMA/OD/153/12
    D.3 Description of the IMP
    D.3.1Product nameTerguride
    D.3.2Product code /
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERGURIDE HYDROGENMALEATE
    D.3.9.1CAS number 37686-85-4
    D.3.9.2Current sponsor code/
    D.3.9.4EV Substance CodeSUB04725MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    D.3.11.13.1Other medicinal product typeAlcaloide dell’ergot semisintetico
    D.IMP: 3
    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 METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE ITALIA S.R.L.
    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.3.1Product nameMetoclopramide
    D.3.2Product code /
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETOCLOPRAMIDE
    D.3.9.1CAS number 364-62-5
    D.3.9.2Current sponsor code/
    D.3.9.3Other descriptive nameMETOCLOPRAMIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboTablet
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diffuse cutaneous systemic sclerosis (dcSSc)
    Sclerosi sistemica cutanea diffusa (dcSSc)
    E.1.1.1Medical condition in easily understood language
    systemic sclerosis
    sclerosi sistemica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042953
    E.1.2Term Systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the efficacy of terguride compared to
    placebo in terms of absolute change in the mRSS during the double-blind
    treatment phase in subjects with dcSSc.
    L’obiettivo primario consiste nel valutare l’efficacia di terguride rispetto al placebo in termini di variazione assoluta dello Skin Score secondo Rodman modificato (mRSS) durante la fase di trattamento in doppio cieco in soggetti affetti da dcSSc.
    E.2.2Secondary objectives of the trial
    The secondary and other objectives include the following:
    • To assess the efficacy of terguride compared to placebo in terms of
    impact on skin thickening, visceral involvement, functional status,
    quality of life, and pharmacodynamic parameters during the double-blind
    treatment phase.
    • To assess the safety of terguride compared to placebo in a 52-week
    double-blind treatment phase.
    • To assess the efficacy and safety of terguride in the open-label, 52-
    week open-label extension phase.
    • To assess the prognostic value of CYP2D6 polymorphism with regard to
    the HIwT terguride dosage.
    Gli obiettivi secondari e gli altri obiettivi includono quanto segue:
    • Valutare l’efficacia di terguride rispetto al placebo in termini di impatto su ispessimento cutaneo, coinvolgimento viscerale, stato funzionale, qualità della vita e parametri farmacodinamici durante la fase di trattamento in doppio cieco.
    • Valutare la sicurezza di terguride rispetto al placebo in una fase di trattamento in doppio cieco di 52 settimane.
    • Valutare l’efficacia e la sicurezza di terguride nella fase di estensione in aperto di 52 settimane.
    • Valutare il valore prognostico del polimorfismo del citocromo P450 (CYP) 2D6 in riferimento al più alto dosaggio di terguride ben tollerato a livello individuale (HIwT).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each subject must meet all of the following criteria to be enrolled in this
    study (criterion #7 must also be met for inclusion in the open-label
    extension phase of the study):
    1. Is a male or female ≥18 years of age.
    2. Fulfills the ACR/EULAR 2013 criteria for classification of SSc
    3. Has diffuse cutaneous involvement (defined by skin fibrosis in at least
    1 of the following sites: upper arms, thorax, abdomen, or thighs)
    according to scleroderma classification criteria (LeRoy et al 1988),
    confirmed independently by a second investigator who is unaware of the
    assessment of the first investigator.
    4. Has a baseline mRSS between 10 and 25 units, inclusive.
    5. Has had onset of the first non-Raynaud's manifestation of SSc within
    36 months of screening.
    6. Is willing and able to comply with all aspects of the study; in
    particular, has the ability to attend study visits and assessments at least
    until the end of the double-blind treatment phase.
    7. If a male subject is capable of reproduction or a female subject is of childbearing potential, he/she consents to practice sexual abstinence (Sexual abstinence refers to refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The
    reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.) or use another highly effective method of contraception (Pearl index < 1), such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion or vasectomy in combination with a second
    method of contraception, such as a condom or a cervical cap/diaphragm with spermicide, during the trial and for at least 6 months thereafter.
    8. Has provided written informed consent.
    Ogni soggetto deve soddisfare tutti i seguenti criteri per poter essere arruolato in questo studio (il criterio #7 deve essere soddisfatto anche per l’inclusione nella fase di estensione in aperto dello studio):
    1. Essere un uomo o una donna di almeno 18 anni.
    2. Soddisfare i criteri del 2013 per la classificazione della sclerosi sistemica (SSc) dell’American College of Rheumatology/European League Against Rheumatism.
    3. Presentare coinvolgimento cutaneo diffuso (definito con fibrosi cutanea in almeno 1 dei seguenti siti: arti superiori, torace, addome o cosce) in base ai criteri di classificazione della sclerodermia (LeRoy 1988), confermato in maniera indipendente da un secondo sperimentatore che è all’oscuro della valutazione del primo sperimentatore.
    4. Presentare un mRSS al basale compreso tra 10 e 25 unità (incluso).
    5. Aver avuto l’insorgenza della prima manifestazione di sclerosi sistemica (SSc) non riconducibile al fenomeno di Raynaud nei 36 mesi antecedenti lo screening.
    6. Essere disposto e in grado di rispettare tutti gli aspetti dello studio, in particolare potersi sottoporre alle visite e alle valutazioni dello studio almeno fino alla fine della fase di trattamento in doppio cieco.
    7. Per i soggetti di sesso maschile in grado di procreare o per i soggetti di sesso femminile in età fertile, è necessario acconsentire alla pratica dell’astinenza sessuale (per astinenza sessuale si intende l’astensione dai rapporti eterosessuali durante l’intero periodo di rischio associato al trattamento in studio. L’affidabilità dell’astinenza sessuale deve essere valutata in relazione alla durata dello studio clinico e allo stile di vita abituale e preferito del soggetto) o all’utilizzo di un altro metodo contraccettivo altamente efficace (Indice di Pearl <1), come la contraccezione ormonale combinata (contenente estrogeno e progestinico) associata all’inibizione dell’ovulazione, la contraccezione ormonale a base di solo progestinico associata all’inibizione dell’ovulazione, un dispositivo intrauterino, un sistema intrauterino a rilascio ormonale, l’occlusione tubarica bilaterale o la vasectomia in combinazione con un secondo metodo contraccettivo, come un preservativo o un diaframma/cappuccio cervicale con spermicida durante lo studio e per almeno 6 mesi successivi.
    8. Aver fornito consenso informato scritto.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will be excluded from the
    study:
    1. Has abnormal hematological values prior to baseline (Visit 2).
    2. Has abnormal liver function tests prior to baseline (Visit 2).
    3. Has abnormal renal function tests prior to baseline (Visit 2).
    4. Has any known renal crisis history.
    5. Has cardiac abnormalities at screening (Visit 1).
    6. Has any of the following lung criteria at screening (Visit 1):
    • Forced vital capacity (FVC) <40% predicted
    • Diffusing capacity of the lung for carbon monoxide (DLCO) <30%
    predicted.
    7. Has a previous diagnosis of severe pulmonary arterial hypertension
    (PAH).
    8. Has malabsorption requiring parenteral nutrition at screening (Visit
    1).
    9. Has had treatment with putative disease-modifying agents within 8
    weeks of screening.
    10. Has had treatment with cyclophosphamide within 26 weeks of
    screening (Visit 1).
    11. Has had treatment with rituximab within 52 weeks of screening
    (Visit 1).
    12. Has a known acute or uncontrolled chronic infection (eg, hepatitis B
    or C, tuberculosis, or human immunodeficiency virus [HIV]).
    13. History of hematopoietic stem cell transplantation or planned
    hematopoietic stem cell transplantation within the next 12 months, or
    total lymphoid irradiation.
    14. Has any concurrent medical condition(s) that, in the opinion of the
    investigator, may confound the results of the study.
    15. Is pregnant or lactating.
    I soggetti che soddisfano uno dei criteri seguenti saranno esclusi dallo studio:
    1. Presentare valori ematici anomali prima del basale (Visita 2)
    2. Presentare valori della funzionalità epatica anomali prima del basale (Visita 2).
    3. Presentare valori della funzionalità renale anomali prima del basale (Visita 2).
    4. Presentare una storia nota di crisi renali.
    5. Presentare un' anomalia cardiaca allo screening (Visita 1).
    6. Presentare uno dei seguenti criteri polmonari allo screening
    (Visita 1):
    • Capacità vitale forzata (FVC) <40% del valore previsto
    • Capacità di diffusione del monossido di carbonio
    (DLCO) <30% del valore previsto (emoglobina corretta)
    7. Presentare una precedente diagnosi di ipertensione arteriosa polmonare grave (PAH).
    8. Presentare malassorbimento richiedente nutrizione parenterale allo screening (Visita 1).
    9. Essersi sottoposto a trattamento con possibili agenti modificanti la malattia nelle 8 settimane antecedenti lo screening.
    10. Essersi sottoposto a trattamento con ciclofosfamide nelle 26 settimane antecedenti lo screening (Visita 1).
    11. Essersi sottoposto a trattamento con rituximab nelle 52 settimane antecedenti lo screening (Visita 1).
    12. Presentare una infezione cronica nota acuta o non controllata (ad esempio, epatite B o C, tubercolosi o virus dell’immunodeficienza umana [HIV]).
    13. Storia di trapianto di cellule staminali emopoietiche o trapianto di cellule staminali emopoietiche programmato nei successivi 12 mesi, oppure irradiazione linfoide totale.
    14. Presentare condizioni mediche che, secondo lo sperimentatore, possono alterare i risultati dello studio.
    15. In caso di gravidanza o allattamento.


    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the absolute change in mRSS between baseline and Week 52 of the double-blind treatment phase.
    L’endpoint primario di efficacia è rappresentato dalla variazione assoluta dell’mRSS tra il basale e la Settimana 52 della fase di trattamento in doppio cieco.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Settimana 52 della fase in doppio cieco.
    Week 52 of double blind phase
    E.5.2Secondary end point(s)
    • The absolute change in total score of the HAQ-DI between baseline and Week 52 of the double-blind treatment phase.
    • The binary mRSS response defined as improvement of mRSS by at least 30% (relative) or 5 points (absolute) between baseline and Week 52 of the double-blind treatment phase.
    • La variazione assoluta nel punteggio totale dell’indice di disabilità ottenuto attraverso il questionario di valutazione dello stato di salute (Health Assessment Questionnaire Disability Index, HAQ-DI) tra il basale e la Settimana 52 della fase di trattamento in doppio cieco.
    • La risposta binaria dell’mRSS definita come miglioramento dell’mRSS per almeno il 30% (relativo) o 5 punti (assoluto) tra il basale e la Settimana 52 della fase di trattamento in doppio cieco.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52 of double blind phase
    Settimana 52 della fase in doppio cieco.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Quality of life
    Qualità di vita.
    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) 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    Belgium
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    Switzerland
    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
    The end of the study is defined as the date on which all subjects have completed, or have had the opportunity to complete, the safety visit (Visit 13).
    Viene definita fine dello studio la data in cui tutti i soggetti hanno completato o hanno avuto la possibilità di completare la visita di sicurezza (Visita 13).
    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 days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 134
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 Yes
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 148
    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)
    Patient's care after end of trial participation will be left at the doctor's discretion. Subjects who would like to remain on protocol-specified therapy after the open-label extension phase has been completed will
    be permitted to continue treatment at the investigator's discretion, as provided for by the local country's regulatory mechanisms. Data collection during this phase will be limited to administration of protocol-specified therapy and SAE reporting.
    L’assistenza al paziente dopo la partecipazione allo studio clinico è lasciata a discrezione del medico. I soggetti che vorranno proseguire la terapia indicata dal protocollo in seguito al completamento della fase di estensione in aperto potranno continuare il trattamento a discrezione dello sperimentatore, come previsto dalla normativa locale del Paese. La raccolta dei dati in questa fase sarà limitata alla somministrazione della terapia indicata dal protocollo e alla segnalazione dei SAE.
    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 Decision2016-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-19
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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