Clinical Trials Register

Summary
EudraCT Number:	2018-001166-42
Sponsor's Protocol Code Number:	152PO17433
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-08-07
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

Spain - AEMPS

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)

Ensayo de fase II multicéntrico, aleatorizado, de grupos paralelos y simple ciego, para evaluar la farmacocinética y la relación PKPD de la trazodona después de dosis orales únicas y repetidas en niños de 2 a ≤17 años de edad que padecen insomnio, con autismo, discapacidad intelectual o trastorno por déficit de atención con hiperactividad (TDAH)

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)

Estudio de investigación clínica para evaluar cómo puede influir la trazodona sobre el sueño, así como su funcionamiento en el cuerpo tras una o varias dosis tomadas por boca, en niños que sufran insomnio y autismo, discapacidad intelectual o trastorno por déficit de atención con hiperactividad (TDAH)

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 ACRAF S.p.A (Angelini 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 ACRAF S.p.A (Angelini S.p.A.)
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, Rome
B.5.3.3	Post code	00071
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 hydrochloride
D.3.4	Pharmaceutical form	Oral drops, solution
D.3.4.1	Specific paediatric formulation	Yes
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	Trazodone hydrochloride
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	trazodone hydrochloride
D.3.4	Pharmaceutical form	Oral drops, solution
D.3.4.1	Specific paediatric formulation	Yes
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	Trazodone hydrochloride
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Insomnio en niños y adolescentes, con autismo, discapacidad intelectual o TDAH

E.1.1.1

Medical condition in easily understood language

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

Insomnio en niños y adolescentes, con autismo, discapacidad intelectual o TDAH

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

El objetivo principal: de este studio es evaluar la farmacocinética (FC) de la trazodona tras una y varias dosis en pacientes de entre 2 y ≤ 17 años.

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.

Los objetivos secundarios:
- Establecer la relación farmacocinética-farmacodinámica (FC-FD) de la trazodona, evaluada a través de mediciones con un actígrafo.
- Evaluar la correlación entre concentración e intervalo QT.
- Definir la justificación de la dosis en niños y adolescentes de 2 a ≤ 17 años teniendo en cuenta el intervalo de exposición terapéutica en adultos.
- Evaluar la seguridad y la tolerancia de la trazodona en niños y adolescentes de entre 2 y ≤ 17 años.
- Valorar la palatabilidad de la 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. Pacientes que hayan proporcionado un consentimiento informado por escrito (incluido el procesamiento de datos personales) firmado por sus padres/tutores legales.
2. Pacientes con asentimiento documentado de acuerdo con su edad y grado de madurez, de conformidad con las consideraciones éticas de 2017 para ensayos clínicos con medicamentos en menores.
3. Niños o niñas de entre 2 y 17 años de edad (ambos incluidos).
4. Pacientes diagnosticados con autismo, discapacidad intelectual o TDAH de acuerdo con los criterios de la Clasificación estadística internacional de enfermedades (ICD-10) (F84.0, F90.9, F79) o el Manual estadístico y de diagnóstico de trastornos mentales, 5.a edición (DSM-5) (299.00, 314.01, 319).
5. Pacientes diagnosticados con insomnio de acuerdo con los criterios de la Clasificación internacional de trastornos del sueño, 3.a edición (ICSD-3; Academia Estadounidense de Medicina del Sueño, 2014).
6. Puntuación total > 60 en la escala de alteraciones del sueño infantil (SDSC).
7. Pacientes que reciban un tratamiento estable para sus trastornos del desarrollo neurológico primario (neurodevelopmental disorders, NDD), al margen de los medicamentos especificados en los «criterios de exclusión».
8. Pacientes que hayan completado el período requerido de reposo farmacológico de 7 días respecto a cualquier medicamento inductor del sueño

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 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 – hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, 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 participating in the evaluation of any investigational product for 3 months before this study (the 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study [i.e. screening visit])
12. Patient is first-degree relative of any of the members of the team involved in the conduct of the study
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

1. Pacientes con hipersensibilidad conocida o sospechada a la trazodona y/o a sus excipientes.
2. Pacientes con antecedentes de reacción anafiláctica a fármacos o reacciones alérgicas en general, que el investigador considere que puedan afectar al resultado del estudio.
3. Pacientes tratados con cualquier forma de trazodona durante las dos semanas previas a la inclusión en el estudio.
4. Pacientes que no hayan respondido a un tratamiento previo a base de trazodona de acuerdo con su historia clínica de los dos últimos años.
5. Pacientes que hayan tomado durante las dos semanas previas al inicio del estudio y a lo largo de este cualquier medicamento (con la excepción de los previstos para sus NDD primarios) que prolongue o corrija el intervalo QT o que esté incluido en la sección «Interacciones con otros medicamentos y otras formas de interacción» de la ficha técnica de la trazodona.
6. Niñas o mujeres afectadas por el síndrome de Rett.
7. Pacientes con diagnóstico de VIH, antígeno de superficie del virus de la hepatitis B o virus de la hepatitis C.
8. Para pacientes embarazadas: embarazo o lactancia materna.
9. Pacientes que sean mujeres adolescentes potencialmente fértiles, sexualmente activas y que no estén dispuestas o no sean capaces de utilizar un método anticonceptivo altamente eficaz, lo que incluye anticonceptivos hormonales combinados con estrógenos y progestágenos (orales, intravaginales, transdérmicos), anticonceptivos hormonales exclusivamente a base de progestágenos (orales, inyectables, implantables), dispositivos intrauterinos, sistema intrauterino liberador de hormonas, ligadura de trompas bilateral, pareja sexual vasectomizada o abstinencia sexual durante como mínimo un mes antes de la inclusión en el estudio, a lo largo del estudio y durante el mes siguiente a la finalización del estudio.
10. Pacientes que sean mujeres adolescentes potencialmente fértiles y que mantengan la abstinencia sexual pero que no acepten seguir practicando la abstinencia o, en caso de comenzar a mantener relaciones sexuales, que no acepten usar uno de los métodos anticonceptivos altamente eficaces.
11. Pacientes que participen en la evaluación de cualquier medicamento en investigación durante los tres meses previos a este estudio (el intervalo de tres meses se calculará como el tiempo transcurrido entre el primer día natural del mes siguiente a la última visita del estudio anterior y el primer día del presente estudio [esto es, la visita de selección]).
12. Pacientes que sean familiares de primer grado de cualquiera de los integrantes del equipo participante en la realización del estudio.
13. Pacientes con un valor del intervalo QT corregido con la fórmula de Fridericia (QTcF) ≥ 440 ms (niños) y ≥ 450 ms (niñas), en todos los grupos de edad.
14. Pacientes con antecedentes de factores de riesgo de taquicardia ventricular en entorchado (p. ej., insuficiencia cardíaca, hipopotasemia, antecedentes familiares de síndrome de intervalo QT prolongado, arritmias cardíacas, bradicardia, anomalías de la conducción cardíaca, hipertrofia cardíaca, cardiomiopatía, insuficiencia cardíaca crónica).
15. Pacientes con antecedentes evidentes de alcoholismo o drogadicción en adolescentes (12 a ≤ 17 años de edad).
16. Pacientes con anomalías físicas o valores anómalos clínicamente significativos en pruebas analíticas que sean relevantes para las evaluaciones del estudio o para la seguridad del paciente.
17. Pacientes con antecedentes de enfermedades renales, hepáticas, gastrointestinales, cardiovasculares, respiratorias, cutáneas, hemáticas, endocrinas o neurológicas significativas que puedan interferir con el objetivo del estudio.
18. Pacientes con antecedentes de pérdida superior al 3 % de su volumen sanguíneo total durante el mes previo a la inclusión en el estudio.
19. Pacientes con cualquier afección (quirúrgica o médica) que afecte a la absorción, la distribución, el metabolismo y/o la excreción del fármaco.
20. Pacientes y padres/tutores legales que no sean capaces de comprender completamente la naturaleza y la finalidad del estudio o de cumplir con los requisitos del estudio.
21. Pacientes que consuman pomelo (como fruto o en zumo) durante los siete días previos a la administración de la primera dosis del medicamento del estudio.
22. Pacientes con un diagnóstico de epilepsia o con uno o más episodios de convulsiones durante los doce meses previos a la selección.

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

Los parámetros FC primarios de la trazodona tras una o varias administraciones orales de trazodona incluirán el aclaramiento oral aparente (CL/F), el volumen de distribución aparente (Vd/F) y la constante de la tasa de absorción (Ka). Los parámetros secundarios se obtendrán a partir de perfiles de modelos previstos: ABC, Cmáx, Cmín, Cee, Cvalle y Tmáx

E.5.1.1

Timepoint(s) of evaluation of this end point

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

V1 (1ª dosis), V2(4ª dosis) y V3(10ª dosis)

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

• El análisis exploratorio de los datos incluirá la correlación entre los parámetros FC (ABC, Cee, Cmáx) y los criterios de valoración clínicos (tiempo de latencia del sueño y tiempo total de sueño) evaluados mediante actigrafía.
• Análisis exploratorio de la correlación entre concentración e intervalo QT.
• Si los datos lo permiten, se aplicará un modelo FC-FD para obtener los parámetros pertinentes como la potencia y los efectos máximos sobre la latencia del sueño y el tiempo total de sueño respecto a los niveles iniciales.

Seguridad/Tolerancia

E.5.2.1

Timepoint(s) of evaluation of this end point

In the course of the study

A lo largo del estudio

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

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

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

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

ültima visita del ultimo paciente

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 months

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

F.3.3.2

Women of child-bearing potential using contraception

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

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, patients will be treated with the available medication according to investigator´s choice

Tras la finalización del ensayo, los pacientes serán tratados con la medicación disponible seguún el criterio del investigador

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

2018-11-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-06

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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