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    Summary
    EudraCT Number:2015-001268-20
    Sponsor's Protocol Code Number:EP0073
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 number2015-001268-20
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF UCB0942 WHEN USED AS ADJUNCTIVE THERAPY FOR PARTIAL-ONSET SEIZURES IN ADULT
    SUBJECTS WITH HIGHLY DRUG-RESISTANT FOCAL EPILEPSY
    STUDIO DI ESTENSIONE IN APERTO, MULTICENTRICO, PER VALUTARE LA SICUREZZA, LA TOLLERABILITÀ E L'EFFICACIA A LUNGO TERMINE DI UCB0942 QUANDO UTILIZZATO COME TERAPIA AGGIUNTIVA PER CRISI PARZIALI IN SOGGETTI ADULTI CON EPILESSIA FOCALE ALTAMENTE RESISTENTE AI FARMACI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label extension study of UCB0942 in adult patients with highly drug-resistant focal epilepsy.
    STUDIO DI ESTENSIONE IN APERTO SU UCB0942 IN SOGGETTI ADULTI CON EPILESSIA FOCALE ALTAMENTE RESISTENTE AI FARMACI
    A.3.2Name or abbreviated title of the trial where available
    An open-label extension study of UCB0942 in adult patients with highly drug-resistant focal epilepsy
    STUDIO DI ESTENSIONE IN APERTO SU UCB0942 IN SOGGETTI ADULTI CON EPILESSIA FOCALE ALTAMENTE RESISTEN
    A.4.1Sponsor's protocol code numberEP0073
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SPRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointCT Registries & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number00492173481515
    B.5.5Fax number00492173481572
    B.5.6E-mailclinicaltrials@ucb.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUCB0942
    D.3.2Product code [UCB0942]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.1CAS number 1294000-61-5
    D.3.9.2Current sponsor codeUCB0942
    D.3.9.4EV Substance CodeSUB33843
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUCB0942
    D.3.2Product code [UCB0942]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.1CAS number 1294000-61-5
    D.3.9.2Current sponsor codeUCB0942
    D.3.9.4EV Substance CodeSUB33843
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 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 nameUCB0942
    D.3.2Product code [UCB0942]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.1CAS number 1294000-61-5
    D.3.9.2Current sponsor codeUCB0942
    D.3.9.4EV Substance CodeSUB33843
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    highly drug-resistant focal epilepsy
    EPILESSIA FOCALE ALTAMENTE RESISTENTE AI FARMACI
    E.1.1.1Medical condition in easily understood language
    highly drug-resistant focal epilepsy
    EPILESSIA FOCALE ALTAMENTE RESISTENTE AI FARMACI
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065337
    E.1.2Term Focal epilepsy
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of UCB0942 at individualized doses between 100mg/day to a maximum of 800mg/day in subjects with highly drug-resistant focal epilepsy.
    Valutare la sicurezza e la tollerabilità a lungo termine di UCB0942 a dosi individualizzate comprese tra 100 mg/giorno fino a un massimo di 800 mg/giorno in soggetti con epilessia focale altamente resistente ai farmaci.
    E.2.2Secondary objectives of the trial
    • To evaluate the long-term efficacy of UCB0942
    • To evaluate the effects of UCB0942 on the subject’s quality of life.
    - Valutare l'efficacia a lungo termine di UCB0942.
    - Valutare gli effetti di UCB0942 sulla qualità della vita dei soggetti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study
    • Subject must have completed V13 of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073
    • In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject
    • In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator
    • No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator
    • Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods.
    • Male subject confirms that, during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom) AND that the respective partner will use an additional contraceptive method
    • Un modulo di consenso informato scritto approvato dal Comitato Etico Indipendente è stato firmato e datato dal soggetto, dopo che lo sperimentatore abbia valutato se il soggetto è in grado di comprendere i potenziali rischi e benefici della partecipazione allo studio
    •Il soggetto deve aver completato V13 del periodo di mantenimento ambulatoriale di EP0069 per poter essere eleggibile all'arruolamento per EP0073
    • In EP0069, il soggetto ha dimostrato una riduzione della frequenza e/o la gravità delle crisi rispetto al basale che è considerato clinicamente significativo dallo sperimentatore e significativo da parte del soggetto
    • In EP0069, il soggetto sperimenta sostanziale beneficio da UCB0942 con tollerabilità accettabile in accordo al soggetto e sperimentatore
    • Nessun problema di tollerabilità che può prevalere sui benefici raggiunti, secondo il parere del ricercatore
    • soggetti di sesso femminile non fertili (premenarca, postmenopausa da almeno 2 anni, ovariectomia bilaterale o legatura delle tube, e completa isterectomia) sono ammissibili. Soggetti di sesso femminile in età fertile sono ammissibili quando utilizzano metodi contraccettivi medicalmente accettati
    • soggetti maschili devono confermare che, durante il periodo di studio e per un periodo di 3 mesi dopo l'ultima dose, quando avranno rapporti sessuali con una donna in età fertile, useranno un contraccettivo di barriera (per esempio, preservativo) e che il rispettivo partner utilizzerà un metodo contraccettivo addizionale
    E.4Principal exclusion criteria
    • Subject has active suicidal ideation as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the “Since Last Visit” version of the Columbia Suicide Severity Rating Scale. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study
    • Subject has taken other (non-Anti-Epileptic Drug) prescription, non-prescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half lives whichever is longer) prior to study entry
    • Subject has an abnormality in the 12-lead electrocardiography that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any subject with any of the following findings will be excluded:
    - Prolonged QTc (Bazett’s, machine-read) interval defined as > 450 ms for males and > 470 ms for females
    - Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval = 220 ms)
    - Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
    - In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration
    • Subject has a clinically significant abnormality on echocardiography at the Entry Visit (V2) of EP0073
    • Il soggetto presenta idee suicide attive, come indicato da una risposta positiva ("Sì") a Domanda 4 o Domanda 5 della versione "dall'ultima visita" del CSSRS. Il soggetto deve essere affidata immediatamente ad un professionista sanitario mentale e deve essere ritirato dallo studio
    • Il soggetto ha assunto altre (farmaco anti antiepilettico) prescrizioni, non soggetti a prescrizione, alimentari (ad esempio, pompelmo o frutto della passione), o prodotti a base di erbe che sono induttori o inibitori potenti del pathway di CYP3A4 per 2 settimane (o 5 emivite a seconda di quale è più lungo) prima dell'ingresso nello studio
    • Il soggetto presenta un'anomalia nell'elettrocardiografia a 12 derivazioni che, a giudizio dello sperimentatore, aumenta i rischi associati alla partecipazione allo studio. Inoltre, qualsiasi soggetto con qualsiasi delle seguenti caratteristiche saranno esclusi:
     - Prolungato QTc (lettura su macchina di Bazett) Intervallo definito come> 450 ms per i maschi e> 470 ms per le femmine
     - blocchi di branca e altre anomalie della conduzione diversi da blocco atrioventricolare di primo grado (definita come intervallo PR = 220 ms)
     - Ritmi irregolari diversi da aritmia sinusale o occasionale, battiti ectopico rari ventricolari o sopraventricolari
     - A giudizio dello Sperimentatore, configurazioni dell'onda T non sono di qualità sufficiente per valutare la durata dell'intervallo QT
    • Il soggetto presenta un'anomalia clinicamente significativo sulla Ecocardiografia alla visita di ingresso (V2) di EP0073
    E.5 End points
    E.5.1Primary end point(s)
    • The 75% Responder Rate at the end of
    the Evaluation Period
    • Percentage of subjects with at least one treatment-emergent Adverse Events during the EP0073 study
    • Percentage Number of subjects with at least one Serious Adverse Event during the EP0073 study
    • Percentage of subjects discontinued due to treatment-emergent Adverse Events during the EP0073 study
    • tasso di responder del 75% alla fine del periodo di valutazione.
    • Percentuale di soggetti con almeno un trattamento da evento avverso durante lo studio EP0073
    • Percentuale di soggetti con almeno un evento avverso serio durante lo studio EP0073
    • Percentuale di soggetti che hanno interrotto lo studio a causa di un trattamento da evento avverso durante lo studio EP0073
    E.5.1.1Timepoint(s) of evaluation of this end point
    58 months
    58 mesi
    E.5.2Secondary end point(s)
    • Median partial-onset seizure frequency per 28 days over the Evaluation Period of the EP0073 study
    • Median partial-onset seizure frequency per 28 days by seizure type over the Evaluation Period of the EP0073 study
    • Percent reduction in partial-onset seizure frequency relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069 over the Evaluation Period of the EP0073 study
    • The 50 % responder rate over the Evaluation Period of the EP0073 study
    • Percentage of seizure-free days over the Evaluation Period
    • Seizure-free rate over the Evaluation Period
    • Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) scores from Visit 3 (Week 2) of EP0069 through the assessment of the Evaluation
    Period
    • frequenza mediana delle crisi a esordio parziale per 28 giorni durante il periodo di valutazione
    dello studio EP0073
    • frequenza mediana delle crisi a esordio parziale per 28 giorni dal tipo di crisi nel corso del Periodo di valutazione dello studio EP0073
    • frequenza di riduzione percentuale a esordio parziale delle crisi rispetto al periodo prospettico di 2 settimane ambulatoriale definito in EP0069 nel corso del periodo di valutazione dello studio EP0073
    • Il tasso di responder del 50% rispetto al periodo di valutazione dello studio EP0073
    • Percentuale di giorni liberi da crisi nel corso del Periodo di valutazione
    • tasso privo di crisi nel corso del Periodo di valutazione
    • Le variazioni di qualità della vita nel punteggio QOLIE-31-P da visita 3 (Settimana 2) di EP0069 attraverso la valutazione
    del periodo di valutazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    58 months
    58 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 Yes
    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.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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    In aperto
    Open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Information not present in EudraCT
    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 years6
    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 years6
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    None.
    nessuno
    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 Decision2016-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
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