Clinical Trials Register

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.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-000105-73

A.3

Full 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.3.1

Title 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

A.3.2

Name or abbreviated title of the trial where available

OPTIMAL study

A.4.1

Sponsor's protocol code number

OPTIMAL

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U0000-0000-0000

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	BANDO RICERCA ISTITUZIONALE 2017
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS Istituto Nazionale Tumori
B.5.2	Functional name of contact point	Clinical Trial Center
B.5.3	Address:
B.5.3.1	Street Address	Via Giacomo Venezian, 1
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390223903063
B.5.5	Fax number	+390223903991
B.5.6	E-mail	trialcenter@istitutotumori.mi.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Metforal
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratori Guidotti S.p.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Metformina
D.3.2	Product code	[Metformina]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Metformina
D.3.9.1	CAS number	657-24-9
D.3.9.2	Current sponsor code	Metforal 850 mg
D.3.9.3	Other descriptive name	Metforal 850 mg
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	662
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Soldesam
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIO FARMACOLOGICO MILANESE S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Desametasone
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Concentrate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Intravenous use Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESAMETASONE
D.3.9.1	CAS number	50-02-2
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	dexamethasone
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESAMETASONE
D.3.9.1	CAS number	50-02-2
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	dexamethasone
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical 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.1.1.1

Medical 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.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10055113
E.1.2	Term	Breast cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10027481
E.1.2	Term	Metastatic melanoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10049790
E.1.2	Term	Lung neoplasm NOS
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

3 months

3 mesi

E.5.2

Secondary 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.5.2.1

Timepoint(s) of evaluation of this end point

3 Months

3 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

110

F.4.2

For a multinational trial

F.4.2.1

In the EEA

110

F.4.2.2

In 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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-05-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-02-26

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials