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    Summary
    EudraCT Number:2019-000105-73
    Sponsor's Protocol Code Number:OPTIMAL
    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 number2019-000105-73
    A.3Full title of the trial
    Efficacy of metfOrmin in PrevenTIng glucocorticoid-induced diabetes in Melanoma, breAst or Lung cancer patients with brain metastases: the phase II OPTIMAL study
    Studio OPTIMAL: Studio di fase II di valutazione dell’efficacia della metformina nel prevenire il diabete indotto dalla terapia con glucocorticoidi in pazienti affetti da melanoma, tumore della mammella o del polmone con metastasi encefaliche.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of metfOrmin in PrevenTIng glucocorticoid-induced diabetes in Melanoma, breAst or Lung cancer patients with brain metastases: the phase II OPTIMAL study
    Studio OPTIMAL: Studio di fase II di valutazione dell’efficacia della metformina nel prevenire il diabete indotto dalla terapia con glucocorticoidi in pazienti affetti da melanoma, tumore della mammella o del polmone con metastasi encefaliche.
    A.3.2Name or abbreviated title of the trial where available
    OPTIMAL study
    OPTIMAL study
    A.4.1Sponsor's protocol code numberOPTIMAL
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 SponsorFONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBANDO RICERCA ISTITUZIONALE 2017
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale Tumori
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Giacomo Venezian, 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number+390223903063
    B.5.5Fax number+390223903991
    B.5.6E-mailtrialcenter@istitutotumori.mi.it
    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 Yes
    D.2.1.1.1Trade name Metforal
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratori Guidotti S.p.A.
    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 nameMetformina
    D.3.2Product code [Metformina]
    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.3.8INN - Proposed INNMetformina
    D.3.9.1CAS number 657-24-9
    D.3.9.2Current sponsor codeMetforal 850 mg
    D.3.9.3Other descriptive nameMetforal 850 mg
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number662
    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 RoleComparator
    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 Soldesam
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIO FARMACOLOGICO MILANESE 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 nameDesametasone
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namedexamethasone
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namedexamethasone
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeup to
    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 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
    Patients with melanoma, lung or breast cancer with encephalic metastases.
    Pazienti con melanoma, tumore del polmone o della mammella con metastasi encefaliche.
    E.1.1.1Medical condition in easily understood language
    Patients with melanoma, lung or breast cancer with encephalic metastases.
    Pazienti con melanoma, tumore del polmone o della mammella con metastasi encefaliche.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049790
    E.1.2Term Lung neoplasm NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 efficacy of metformin in preventing precocious (14 days) dexamethasone-induced diabetes, as defined as fasting plasma glucose levels = 126 mg/dl, in patients with brain metastases from melanoma, lung or breast cancer.
    Valutare l’efficacia della metformina nel prevenire l’insorgenza precoce (entro 14 giorni) del diabete indotto da desametasone, inteso come livelli di glucosio plasmatico = 126 mg/dl
    E.2.2Secondary objectives of the trial
    1. To study the efficacy of metformin in preventing dexamethasone-induced diabetes at different time points (day 4, day 7, day 30) after dexamethasone initiation
    2. To evaluate the efficacy of metformin in reducing short-term mortality (3 months) in patients taking high-dose dexamethasone
    3. To evaluate the efficacy of metformin in improving the local disease control rate (brain) in patients treated with radiation therapy (RT) plus dexamethasone.
    4. To test the impact of metformin on precocious worsening of patient ECOG Performance Status (PS) at 1 month after initiation of dexamethasone therapy.
    5. To investigate the effect of adding metformin on patient Quality of Life (QoL)
    1. Studiare l’efficacia della metformina nel prevenire l’insorgenza del diabete indotto dal desametasone a differenti intervalli di tempo (4°, 7°, 30° giorno) dall’avvio di desametasone.
    2. Valutare la efficacia della metformina nel ridurre la mortalità a breve termine (entro 3 mesi) in paziente che assumono alte dosi di desametasone.
    3. Confrontare il controllo di malattia a livello encefalico dopo completamento della radioterapia (RT) tra pazienti sottoposti a RT più desametasone in associazione o meno alla metformina.
    4. Verificare l’impatto della metformina sul peggioramento precoce del Performance Status secondo ECOG (PS) del paziente dopo un mese dall’inizio della terapia con desametasone.
    5. Studiare l’effetto dell’aggiunta della metformina sulla qualità di vita (QoL) del paziente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age = 18 years and = 75 years
    2. Written informed consent
    3. Histologically confirmed diagnosis of melanoma, lung (SCLC or NSCLC) or breast cancer
    4. Recent (28 days), radiologically documented (contrast-enhanced CT or MRI) diagnosis of measurable brain metastases requiring treatment with high-dose dexamethasone (at least 8 mg daily for at least 21 days) plus/minus radiation therapy (RT).
    5. Any previous or ongoing antitumor systemic therapy; patients who have never received previous systemic therapy can be also included.
    6. Fasting glycemia < 126 mg/dl at the baseline evaluation or random glycemia of less than 200 mg/dl if the patient has not fasted for at least 8 hours before blood sampling.
    7. Adequate blood tests:
    - Hemoglobin = 9 g/dl
    - Absolute neutrophil count (ANC) in the range between 1.5-10 x 103/µl
    - Total bilirubin = 1.5 times the upper normal limit (UNL). For patients with Gilbert syndrome or known liver metastases, bilirubin levels = 3 times the UNL are considered acceptable
    - AST, ALT = 3 times the UNL
    - Alkaline phosphatase = 2.5 times the UNL
    - Serum creatinine concentration = 1.5 x UNL and Glomerular Filtration Rate (GFR) > 30 ml/min;
    8. ECOG Performance Status < or equal 2
    9. Life expectancy > 6 weeks
    10. Ability to swallow metformin tablets
    11. Patients of female gender with the potential of childbearing (neither surgically sterile nor 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for at least 60 days after study conclusion. Acceptable methods of contraception include double barrier method [i.e. condom and occlusive cap (diaphragm or cervical vault caps)] spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method.
    1. Età = 18 anni e =75 anni.
    2. Capacità di comprendere il significato e di fornire consenso informato scritto, nonché di effettuare le procedure previste dal protocollo.
    3. Diagnosi istologicamente confermata di carcinoma infiltrante della mammella, del polmone (SCLC or NSCLC) o melanoma.
    4. Riscontro radiologico recente (entro i 28 giorni dall’inserimento nello studio) mediante TC con mdc o RMN di metastasi encefaliche misurabili candidate a trattamento con alte dosi di desametasone (almeno 8 mg/die per almeno 21 giorni).
    5. E’ permessa qualsiasi terapia sistemica oncologica precedente o in corso; possono essere inclusi anche pazienti che non hanno mai ricevuto terapia sistemica.
    6. Glicemia basale a digiuno < 126 mg/dl o glicemia < 200 mg/dl se il paziente non è a digiuno da almeno 8 ore.
    7. Esami di laboratorio compatibili con le seguenti caratteristiche:
    - emoglobina = 9.0 g/dl;
    - conta assoluta dei neutrofili compresa tra 1.5 e 10 x 103/l;
    - bilirubina totale = 1.5 volte i limiti normali superiori del range di normalità istituzionale (ULN) o =3,0 x ULN se malattia di Gilbert o metastasi epatiche note;
    - alanina aminotransferasi (ALT o SGOT) e aspartato aminotransferasi (AST o SGPT) = 3 x ULN;
    - fosfatasi alcalina = 2.5 x UNL;
    - creatinina sierica = 1.5 x UNL e Filtrato Glomerulare (GFR) > 30 ml/min;
    8. Performance status ECOG = 2.
    9. Aspettativa di vita > 6 settimane.
    10. Capacità di assumere le compresse di metformina
    11. Le donne in età fertile (non chirurgicamente sterili o in menopausa 2 anni) e gli uomini con partner di sesso femminile in età fertile devono accettare di usare metodi efficaci di controllo delle nascite per tutto il periodo di durata dello studio e almeno 60 giorni dopo la conclusione dello studio. Metodi accettabili di contraccezione includono metodi a doppia barriera [es. preservativo e cappuccio occlusivo (diaframma o tappi/a volta cervicale)] spermicida, dispositivo intrauterino (IUD), o contraccettivi steroidei (orale, transdermico, impiantato, e iniettato) in combinazione con un metodo di barriera
    E.4Principal exclusion criteria
    1. Leptomeningeal carcinomatosis, either radiologically documented or cytologically confirmed
    2. History of brain metastases
    3. Diagnosis of other malignancies in the last 5 years, except for superficial, radically treated basal cell carcinomas of the skin or in situ carcinomas of the cervix
    4. Treatment with any protocol prohibited medications (including prior or current use of metformin), within 12 weeks or five half-lives of the drug, whichever is longer, prior to start of study treatment (see 9.6.1. for detailed list).
    5. Ongoing therapy with systemic glucocorticoids at a dosage that is higher than 10 mg prednisone equivalent. Previous GC treatment is allowed if stopped at least 2 months before enrollment. Inhaled or topical steroids are permitted.
    6. Diagnosis of Type 1 or Type 2 diabetes mellitus
    7. Known history of HBV- or HCV-related infection
    8. Known liver cirrhosis, even in the absence of significant alterations in blood tests
    9. (Severe chronic renal failure, defined as a GFR =30 ml/min or acute medical illness, including severe sepsis, hypotension, dehydration, shock, which could impair renal function.
    10.Clinically uncontrolled disorders of the lung, kidney, liver or cardio-vascular apparatus
    11. Known history of HIV infection
    12. Serious neurological or psychiatric disorders
    13. Absence of a caregiver for patients with an ECOG performance status of 2
    14. Pregnancy or lactation. Negative serum or urine pregnancy test is required within 14 days prior start of study treatment for women of childbearing potential.
    15. Body mass index < 18.5 kg/m2
    16. Past or current alcohol abuse (> 36 grams/day for men and 24grams/day for women)
    17. Documented metabolic acidosis from any cause in the last 5 years
    18. History of allergy or hypersensitivity to study drug components
    1. Carcinomatosi leptomeningea confermata radiologicamente o mitologicamente.
    2. Storia di metastasi encefaliche.
    3. Diagnosi di altra patologia oncologica entro 5 anni dall’ingresso nello studio, con l’eccezione del carcinoma basocellulare della cute o del carcinoma in situ della cervice radicalmente asportati.
    4. Uso precedente o in corso una terapia vietata per questo studio (inclusa metformina) nelle 12 settimane o 5 emivite precedenti lo screening, a seconda di quale periodo sia più lungo.
    5. Terapia con glucocorticoidi (GC) sistemici. E’ concessa una pregressa terapia con GC se interrotta almeno 2 mesi prima dell’arruolamento. Sono permessi steroidi inalatori o topici.
    6. Diagnosi di diabete mellito tipo 1 o 2.
    7. Storia nota di infezione da HBV o HCV.
    8. Nota cirrosi epatica, anche in assenza di alterazioni significative degli esami di laboratorio.
    9. Insufficienza renale cronica severa (GFR = 30 ml/min) o condizioni acute con possibilità di alterazione della funzione renale come: disidratazione, sepsi grave, shock.
    10. Disturbi polmonari, epatici o cardio-vascolari non controllati.
    11. Nota positività al virus dell’immunodeficienza umana (HIV).
    12. Disturbi neurologici o psichiatrici gravi.
    13. Assenza di un caregiver per pazienti con ECOG 2.
    14. Gravidanza o allattamento. È necessario, per le donne in età fertile, un test di gravidanza sierico o urinario effettuato nei 14 giorni precedenti l’inizio del trattamento.
    15. Indice di massa corporea (Body Mass Index :BMI) < 18.5 kg/m2.
    16. Pregressa storia di potus o abuso abituale di alcool (>36 g/die per l’uomo e 24 g/die per la donna)
    17. Condizione di acidosi metabolica negli ultimi 5 anni
    18. Nota allergia o ipersensibilità al trattamento o a componenti usati nella preparazione della metformina.
    E.5 End points
    E.5.1Primary end point(s)
    Dexamethasone-induced diabetes (fasting glycemia =126 mg/dl) in patients with brain metastases from melanoma, lung or breast cancer, and treated with or without metformin.
    Valutazione dell’efficacia della metformina nel prevenire il diabete indotto dalla terapia con glucocorticoidi in pazienti affetti da melanoma, tumore della mammella o del polmone con metastasi encefaliche.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    E.5.2Secondary end point(s)
    1. Dexamethasone-induced diabetes at different time points (day 4, day 7, day 30) after dexamethasone initiation
    2. Short-term mortality (3 months) after dexamethasone initiation
    3. Brain local control rate of disease at 1 months after dexamethasone initiation
    4. Precocious (1 month) worsening of patient ECOG performance status (PS) after initiation of dexamethasone therapy.
    5. Patient Quality of Life (QoL)
    1. Diabete indotto da desametasone in diversi momenti (giorno 4, giorno 7, giorno 30) dopo l'inizio del desametasone
    2. Mortalità a breve termine (3 mesi) dopo l'inizio del desametasone
    3.Tasso di controllo locale della malattia a 1 mese dopo l'inizio del desametasone
    4.Precoce peggioramento (1 mese) dello stato di prestazione ECOG del paziente (PS) dopo l'inizio della terapia con desametasone.
    5. Qualità della vita del paziente (QoL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 Months
    3 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 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 Information not present in EudraCT
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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)
    An observation period is foreseen for each patient of 3 months.
    é previsto un periodo di osservazione per ogni paziente di 3 mesi.
    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 Decision2019-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-26
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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