Clinical Trials Register

Summary
EudraCT Number:	2018-001166-42
Sponsor's Protocol Code Number:	152PO17433
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-12-17
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-001166-42

A.3

Full title of the trial

A multi-centre, randomized, parallel-group, single blind Phase II trial to evaluate the pharmacokinetics and PKPD relationship of trazodone after single and repeated oral doses in children from 2 to ≤ 17 years of age, suffering from insomnia, with autism, intellectual disability or attention deficit hyperactivity disorder (ADHD)

Studio di fase II multicentrico, randomizzato, a gruppi paralleli, in singolo cieco, per valutare la farmacocinetica e la correlazione PKPD del trazodone dopo dosi orali singole e ripetute, in bambini di età compresa tra 2 e ≤ 17 anni, che soffrono di insonnia ed affetti da autismo, disabilità intellettiva o disturbo da deficit di attenzione e iperattività (ADHD) .

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical research study to determine how "trazodone" can influence the sleep and how it works in the body after one or repeated doses taken by mouth, in children suffering from insomnia and with autism, intellectual disability or attention deficit hyperactivity disorder (ADHD)

Studio clinico di ricerca per determinare come il "trazodone" può influenzare il sonno e come funziona nel corpo dopo una o più dosi assunte per bocca, nei bambini che soffrono di insonnia e con autismo, disabilità intellettiva o disturbo da deficit di attenzione e iperattività (ADHD)

A.3.2

Name or abbreviated title of the trial where available

Clinical research study to determine how "trazodone" can influence the sleep and how it works in the

Studio clinico di ricerca per determinare come il "trazodone" può influenzare il sonno e come funzio

A.4.1

Sponsor's protocol code number

152PO17433

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/396/2017

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.
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	Aziende Chimiche Riunite Angelini Francesco ACRAF S.p.a. (Angelini s.p.a.)
B.5.2	Functional name of contact point	Valeria Tellone -Study Manager
B.5.3	Address:
B.5.3.1	Street Address	Piazzale della Stazione snc
B.5.3.2	Town/ city	Pomezia, Roma
B.5.3.3	Post code	000171
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390691045306
B.5.5	Fax number	003978332434
B.5.6	E-mail	v.tellone@angelini.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	No
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	trazodone hydroclorite
D.3.2	Product code	152PO17433
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	trazodone hidrocloride
D.3.9.1	CAS number	25332-39-2
D.3.9.2	Current sponsor code	152
D.3.9.4	EV Substance Code	SUB15596MIG
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	30
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	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	No
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	Tetradozone hidrochloride
D.3.2	Product code	152PO17433
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Trazodone Hydrocloride
D.3.9.1	CAS number	25332-39-2
D.3.9.2	Current sponsor code	152
D.3.9.4	EV Substance Code	SUB15596MIG
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	15
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

Insomnia in children and adolescents with autism, intellectual disability or ADHD

Insonnia nei bambini e negli adolescenti con autismo, disabilità intellettiva o ADHD

E.1.1.1

Medical condition in easily understood language

Insomnia in children and adolescents with autism, intellectual disability or ADHD

Insonnia nei bambini e negli adolescenti con autismo, disabilità intellettiva o ADHD

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10022443
E.1.2	Term	Insomnia related to another mental condition
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to assess the PK of trazodone after single and repeated doses in patients aged from 2 to ≤ 17 years

L'obiettivo principale di questo studio è di valutare la PK di trazodone dopo dosi singole e ripetute in pazienti di età compresa tra 2 e 17 anni

E.2.2

Secondary objectives of the trial

The secondary objectives of this study are:
- to establish the pharmacokinetic-pharmacodynamics (PKPD) relationship of trazodone, as assessed by actigraph measures.
- to evaluate the concentration-QT internal correlation.
- to define the dose rationale in children and adolescents aged from 2 to ≤ 17 years taking into account the therapeutic exposure range in adults.
- to evaluate the safety and tolerability of trazodone in children and adolescents aged from 2 to ≤ 17 years.
- to assess palatability of trazodone.

Gli obiettivi secondari di questo studio sono:
- stabilire la relazione farmacocinetica-farmacodinamica (PKPD) del trazodone, valutata mediante misure actigrafiche.
- valutare la correlazione interna concentrazione-QT.
- definire la dose razionale in bambini e adolescenti di età compresa tra 2 e ≤ 17 anni, tenendo conto dell'intervallo di esposizione terapeutica negli adulti.
- valutare la sicurezza e la tollerabilità del trazodone in bambini e adolescenti di età compresa tra 2 e 17 anni.
- valutare l'appetibilità del trazodone.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient provided a signed written informed consent (including personal data processing) by parents/legal guardian
2. Patient with documented assent by patient in accordance with age and maturity level, in line with 2017 ethical considerations for clinical trials on medicinal products conducted with minors
3. Patient is male or female, 2-17 years of age (inclusive)
4. Patient diagnosed with autism, intellectual disability or ADHD according to ICD-10 (F84.0, F90.9, F79) or DSM-5 (299.00, 314.01, 319) criteria
5. Patient diagnosed with insomnia according to ICSD-3 (American Academy of Sleep Medicine, 2014) criteria
6. Sleep disturbance scale for children with a total score > 60
7. Patient on a stable therapy for their primary neurodevelopmental disorders (NDDs), apart from medications specified in the ‘exclusion criteria’
8. Patient taking any sleep-inducing medication has completed the required wash-out period of 7 days

1. Il paziente ha fornito un consenso informato firmato (incluso l'elaborazione dei dati personali) da parte di genitori / tutore legale
2. Paziente con consenso documentato in base all'età e al livello di maturità, in linea con le considerazioni etiche del 2017 per le sperimentazioni cliniche su medicinali condotte con minori
3. Il paziente è maschio o femmina, 2-17 anni (incluso)
4. Paziente con diagnosi di autismo, disabilità intellettiva o ADHD secondo i criteri ICD-10 (F84.0, F90.9, F79) o DSM-5 (299.00, 314.01, 319)
5. Paziente con diagnosi di insonnia secondo i criteri ICSD-3 (American Academy of Sleep Medicine, 2014)
6. Scala del disturbo del sonno per i bambini con un punteggio totale> 60
7. Paziente in terapia stabile per i suoi principali disturbi dello sviluppo neurologico (NDD), oltre ai farmaci specificati nei "criteri di esclusione"
8. Il paziente che ha assunto un farmaco che induce il sonno ha completato il periodo di wash-out richiesto di 7 giorni

E.4

Principal exclusion criteria

1. Patient with ascertained or presumptive hypersensitivity to trazodone and/or its excipients
2. Patient with history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
3. Patient treated with any form of trazodone within 2 weeks prior to the inclusion in the study
4. Patient not responding to previous trazodone-based therapy based on past medical history records in the last 2 years
5. Patient taking any medications (except those foreseen for their primary NDDs) that prolong the QT/corrected QT interval or included in the "Interactions with other medicinal products and other forms of interaction" of trazodone Summary of Product Characteristics within 2 weeks before the start of the study and during the study duration
6. Patient is female affected by Rett syndrome
7. Patient with a previous diagnosis of HIV, hepatitis B virus surface antigen or hepatitis C virus
8. For female patient: pregnancy or lactation
9. Patient is adolescent female of childbearing potential who is sexually active and unwilling or unable to use an highly effective birth control method, which includes combined ( estrogen and progestogen containing) – hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, sexual abstinence for at least 1 month prior to study entry, throughout the duration of the study and 1 month following study completion
10. Patient is adolescent female of childbearing potential who is sexually abstinent and does not agree to continue practicing abstinence or to use one of the highly effective birth control methods should her sexual activity commence
11.Patient is adolescent male who is sexually active and unwilling or unable to use a condom as contraception method throughout the duration of the study and 1 month following study completion
12. Patient is adolescent male who is sexually abstinent and does not agree to continue practicing abstinence or to use a condom as contraception method throughout the duration of the study and 1 month following study completion.
13. Patient with corrected QT interval using Fridericia´s formula (QTcF) value ≥440 msec for male and ≥450 msec for female, for all age groups
14. Patient with history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT syndrome, cardiac arrhythmias, bradycardia, cardiac conduction abnormalities, cardiac hypertrophy, cardiomyopathy, chronic cardiac insufficiency)
15. Patient with evident history of drug and/or alcohol abuse in adolescents (12 to ≤ 17 years of age)
16. Patient with physical abnormalities or clinically significant abnormal laboratory test results relevant for the study assessments or the patient’s safety
17. Patient with history of significant renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
18. Patient with history of blood loss exceeding 3% of the patient’s total blood volume within 1 month before the study
19. Patient with any condition (surgical or medical) which will affect absorption, distribution, metabolism and/or excretion of the drug
20. Patient and parents/legal guardian, who are unable to comprehend the full nature and purpose of the study and to comply with the requirements of the study
21. Patient consuming grapefruit, pomelo, grapefruit juice or pomelo juice within 7 days prior to the first dose of study medication
22. Patient with a diagnosis of epilepsy or with one or more seizures in the 12 months before screening
23. Patient consuming grapefruit, pomelo, grapefruit juice or pomelo juice within 7 days prior to the first dose of study medication
24. Patient with a diagnosis of epilepsy or with one or more seizures in the 12 months before screening
25.Patient with a history of suicide-related events or exhibiting a significant degree of suicidal ideation, or known to be at greater risk of suicidal thoughts or suicide attempts according to the investigator's judgement
26. Patient with any psychiatric disorder other than autism, intellectual disability or attention deficit hyperactivity disorder, that may interfere with the conduct of the study according to the investigator's judgement

Paziente con ipersensibilità accertata o presunta a trazodone e / o ai suoi eccipienti
2. Paziente con anamnesi di anafilassi a farmaci o reazioni allergiche in generale, che lo sperimentatore ritiene possa influenzare l'esito dello studio
3. Paziente trattato con qualsiasi forma di trazodone entro 2 settimane prima dell'inclusione nello studio
4. Paziente che non risponde alla precedente terapia a base di trazodone sulla base di precedenti precedenti di anamnesi medica negli ultimi 2 anni
5. Pazienti che assumono farmaci (eccetto quelli previsti per i loro NDD primari) che prolungano il QT / intervallo QT corretto o inclusi nelle "Interazioni con altri medicinali e altre forme di interazione" del riassunto delle caratteristiche del prodotto trazodone entro 2 settimane prima della inizio dello studio e durante la durata dello studio
6. Il paziente è affetto da sindrome di Rett
7. Paziente con precedente diagnosi di HIV, antigene di superficie del virus dell'epatite B o virus dell'epatite C.
8. Per la paziente: gravidanza o allattamento
9. La paziente è una femmina adolescente in età fertile che è sessualmente attiva e che non vuole o non è in grado di utilizzare un metodo di controllo delle nascite altamente efficace, che include la combinazione (estrogeno e progestinico) di contraccettivi ormonali associati all'inibizione dell'ovulazione (orale, intravaginale, transdermica) , contraccettivo ormonale progestogenico associato a inibizione dell'ovulazione (orale, iniettabile, impiantabile), dispositivo intrauterino, sistema di rilascio di ormone intrauterino, astinenza sessuale per almeno 1 mese prima dell'ingresso nello studio, per tutta la durata dello studio e 1 mese successivo completamento dello studio
10. Il paziente è una femmina adolescente di potenziale fertile che è sessualmente astinente e non accetta di continuare a praticare l'astinenza o di utilizzare uno dei metodi di controllo delle nascite altamente efficaci se la sua attività sessuale inizia
11. Il paziente è un maschio adolescente che è sessualmente attivo e che non vuole o non può usare il preservativo come metodo contraccettivo per tutta la durata dello studio e 1 mese dopo il completamento dello studio.
12. Il paziente è un maschio adolescente che è sessualmente astinente e non accetta di continuare a praticare l'astinenza o di usare il preservativo come metodo contraccettivo per tutta la durata dello studio e 1 mese dopo il completamento dello studio.
13. Paziente con intervallo QT corretto utilizzando il valore della formula di Fridericia (QTcF) ≥440 msec per il maschio e ≥450 msec per la femmina, per tutte le fasce di età
14. Paziente con anamnesi di fattori di rischio per torsione di punta (ad esempio insufficienza cardiaca, ipopotassiemia, storia familiare di sindrome del QT lungo, aritmie cardiache, bradicardia, anormalità della conduzione cardiaca, ipertrofia cardiaca, cardiomiopatia, insufficienza cardiaca cronica)
15. Paziente con una storia evidente di abuso di droghe e / o alcol negli adolescenti (da 12 a ≤ 17 anni di età)
16. Paziente con anomalie fisiche o risultati anormali di test di laboratorio clinicamente significativi rilevanti per le valutazioni dello studio o per la sicurezza del paziente
17. Paziente con anamnesi di patologie renali, epatiche, gastrointestinali, cardiovascolari, respiratorie, cutanee, ematologiche, endocrine o neurologiche che possono interferire con lo scopo dello studio
18. Paziente con storia di perdita di sangue superiore al 3% del volume totale di sangue del paziente entro 1 mese prima dello studio
19. Paziente con qualsiasi condizione (chirurgica o medica) che influenzerà l'assorbimento, la distribuzione, il metabolismo e / o l'escrezione del farmaco
20. Pazienti e genitori / tutori legali, che non sono in grado di comprendere la natura e lo scopo dello studio e di rispettare i requisiti dello studio
21. Paziente che consuma pompelmo, pomelo, succo di pompelmo o succo di pomelo entro 7 giorni prima della prima dose del farmaco in studio
22. Paziente con diagnosi di epilessia o con una o più convulsioni nei 12 mesi precedenti lo screening
23. Paziente che consuma pompelmo, pomelo, succo di pompelmo o succo di pomelo entro 7 giorni prima della prima dose del farmaco in studio
24. Paziente con diagnosi di epilessia o con una o più crisi nei 12 mesi precedenti lo screening 25.Paziente con una storia di eventi correlati al suicidio o che presentano un grado significativo di ideazione suicidaria, o che sono a maggior rischio di pensieri suicidi o tentativi di suicidio secondo il giudizio dello sperimentatore
26. Paziente con qualsiasi disturbo psichiatrico diverso dall'autismo, disabilità intellettiva o disturbo da deficit di attenzione e iperattività , che potrebbe interferire con la conduzione dello studio secondo il giudizio dello sperimentatore

E.5 End points

E.5.1

Primary end point(s)

Primary PK parameters for trazodone after single and repeated oral administration of trazodone will include apparent oral clearance (CL/F), apparent volume of distribution (Vd/F) and, absorption rate constant (Ka). Secondary parameters will be derived from model predicted profiles: AUC, Cmax, Cmin, Css, Ctrough, Tmax

I parametri primari di PK per trazodone dopo somministrazione orale singola e ripetuta di trazodone includeranno la clearance orale apparente (CL / F), il volume apparente di distribuzione (Vd / F) e la costante di velocità di assorbimento (Ka). I parametri secondari saranno derivati dai profili previsti dal modello: AUC, Cmax, Cmin, Css, Ctrough, Tmax

E.5.1.1

Timepoint(s) of evaluation of this end point

V1(1st dose), V2 (4th dose) and V3(10th dose)

V1 (1° dose), V2 (4° dose) e V3 (10° dose)

E.5.2

Secondary end point(s)

Pharmacodynamic Parameters: • Exploratory analysis of the data will include correlation between PK parameters (AUC, Css, Cmax) and clinical endpoints (sleep latency time and total sleeping time) as assessed by actigraphy • Exploratory analysis of concentration-QT interval correlation • If data allows, PKPD modelling will be applied to derive relevant parameters, such as potency and maximum effects on sleep latency and total sleep time from baseline levels Safety/Tolerability

Parametri farmacodinamici: • L'analisi esplorativa dei dati includerà la correlazione tra parametri PK (AUC, Css, Cmax) e endpoint clinici (tempo di latenza del sonno e tempo totale di sonno) come valutato mediante l'actigrafia • Analisi esplorativa della correlazione dell'intervallo QT di concentrazione • Se i dati consente, la modellazione PKPD verrà applicata per derivare parametri rilevanti, come potenza e massimo effetto sulla latenza del sonno e tempo totale di sonno dai livelli di base Sicurezza / Tollerabilità

E.5.2.1

Timepoint(s) of evaluation of this end point

In the course of the study

Nel corso dello studio

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

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

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)

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

LPLV

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

F.3.3.1

Women of childbearing potential not using contraception

Information not present in EudraCT

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

Information not present in EudraCT

F.3.3.4

Nursing women

Information not present in EudraCT

F.3.3.5

Emergency situation

Information not present in EudraCT

F.3.3.6

Subjects incapable of giving consent personally

Information not present in EudraCT

F.3.3.7

Others

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

After the end of the trial, the patients will be treated with the available medication according to the investigator's choice

Dopo la fine dello studio i pazienti saranno trattati con i farmaci disponibili in accordo con lo sperimentatore

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

2018-09-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-25

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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