Clinical Trials Register

Summary
EudraCT Number:	2018-004456-38
Sponsor's Protocol Code Number:	E2007-G000-236
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-09-04
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2018-004456-38

A.3

Full title of the trial

An Open-Label Study with Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy

Estudio abierto con fase de extensión para evaluar la eficacia y la seguridad de perampanel administrado como tratamiento complementario en sujetos pediátricos (de 1 mes a menos de 18 años de edad) con epilepsia infantil.

A.3.1

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

A study to evaluate efficacy and safety of perampanel when administered together with other current antiepileptic medications in children with epilepsy

Estudio para evaluar la eficacia y la seguridad de perampanel cuando se administra junto con otros medicamentos antilepticos habituales en niños con epilepsia

A.4.1

Sponsor's protocol code number

E2007-G000-236

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/308/2018

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Eisai Limited
B.1.3.4	Country	United Kingdom
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	Eisai, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eisai Europe Ltd.
B.5.2	Functional name of contact point	Medical Information
B.5.3	Address:
B.5.3.1	Street Address	European Knowledge Centre, Mosquito Way
B.5.3.2	Town/ city	Hatfield
B.5.3.3	Post code	AL10 9SN
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+34639 710 089
B.5.5	Fax number	+4402086001388
B.5.6	E-mail	EUMedInfo@eisai.net

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	Fycompa
D.2.1.1.2	Name of the Marketing Authorisation holder	Eisai GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Perampanel
D.3.2	Product code	E2007
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	Perampanel
D.3.9.1	CAS number	380917-97-5
D.3.9.2	Current sponsor code	E2007
D.3.9.3	Other descriptive name	PERAMPANEL
D.3.9.4	EV Substance Code	SUB32160
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	2
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	Yes
D.2.1.1.1	Trade name	Fycompa
D.2.1.1.2	Name of the Marketing Authorisation holder	Eisai GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Perampanel
D.3.2	Product code	E2007
D.3.4	Pharmaceutical form	Oral suspension
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	Perampanel
D.3.9.1	CAS number	380917-97-5
D.3.9.2	Current sponsor code	E2007
D.3.9.3	Other descriptive name	PERAMPANEL
D.3.9.4	EV Substance Code	SUB32160
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	2
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	Yes
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

Seizures associated with paediatric epilepsy syndromes and partial-onset seizures

Crisis asociadas con sindromes de epilepsia pediatrica y crisis de inicio parcial

E.1.1.1

Medical condition in easily understood language

Epilepsy

Epilepsia

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	21.0
E.1.2	Level	PT
E.1.2	Classification code	10015037
E.1.2	Term	Epilepsy
E.1.2	System Organ Class	10029205 - Nervous system 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

Evaluate the efficacy of perampanel as measured by
the 50% responder rate.

Evaluar la eficacia de perampanel, determinada mediante la tasa con respuesta del 50 %

E.2.2

Secondary objectives of the trial

1. To evaluate the efficacy of perampanel as measured by the proportion of subjects who are seizure-free.
2. To evaluate the efficacy of perampanel as measured by absolute reduction and percentage of reduction in seizure frequency per 28 days.
3. To evaluate the effects of perampanel on the Clinical Global Impression (CGI).
4. To evaluate the effects of perampanel on the Subject Global Impression (SGI).
5. To evaluate the effects of perampanel on cognition, behavior, and growth and development.
6. To evaluate the efficacy of perampanel as measured by the proportion of responders.
7. To evaluate the efficacy of perampanel as measured by responder rate.
8. To characterize the PK of perampanel and explore exposure/response relationship.
9. To evaluate the safety and tolerability of perampanel.

1. Evaluar la eficacia de perampanel, determinada mediante la proporción de sujetos que se queden sin crisis
2. Evaluar la eficacia de perampanel, determinada mediante la reducción absoluta y la reducción porcentual de la frecuencia de crisis en 28 días.
3.Evaluar los efectos de perampanel sobre la escala CGI (Impresión clínica global)
4.Evaluar los efectos de perampanel sobre la escala SGI (Impresión global del sujeto)
5.Evaluar los efectos de perampanel sobre la función cognitiva, la conducta y el crecimiento y desarrollo
6.Evaluar la eficacia de perampanel, determinada mediante la proporción de sujetos con respuesta
7.Evaluar la eficacia de perampanel, determinada mediante la tasa de sujetos con respuesta
8.Determinar la farmacocinética (FC) de perampanel y explorar posibles relaciones entre exposición/respuesta
9.Evaluar la seguridad y tolerabilidad de perampanel.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet all of the following criteria to be included in this study:
1. Male or female subject, from age 1 month to less than 18 years.
2. Have a diagnosis of epilepsy with a pediatric epileptic syndrome or epilepsy with POS with or without secondary generalization.
3. Subjects must have had equal or greater than 4 seizures over the 4-week interval prior to Visit 2.
4. Have had brain imaging before Visit 1 that ruled out a progressive cause of epilepsy.
5. Are currently being treated with stable doses of 1 to a maximum of 4 approved AEDs. Doses must be stable for at least 4 weeks (at least 2 weeks for subjects <6 months old) before Visit 1; only 1 EIAED out of the maximum of 4 AEDs is allowed.

1. Sujetos de cualquier sexo y de entre un mes y menos de 18 años.
2.Diagnóstico de epilepsia, con un síndrome epiléptico pediátrico o epilepsia con CIP con o sin generalización secundaria
3.Presencia de 4 o más crisis durante el intervalo de 4 semanas previo a la visita 2.
4.Estudio de imagen cerebral realizado antes de la visita 1 que descarte una causa progresiva de la epilepsia.
5. Tratamiento activo con dosis estables de entre uno y un máximo de 4 antiepilépticos aprobados. Las dosis deberán permanecer estables durante al menos 4 semanas (2 semanas en los sujetos menores de 6 meses) antes de la visita 1; solo se permitirá un antiepiléptico inductor enzimático (AEIE) entre los 4 antiepilépticos como máximo.

E.4

Principal exclusion criteria

Subjects who meet any of the following criteria will be excluded from this study:
1. Females who are breastfeeding or pregnant at Screening or Baseline.
2. Females of childbearing potential who:
 Within 28 days before study entry, did not use a combination of a barrier method with a highly effective method of contraception.
 Do not agree to use a combination of a barrier method with a highly effective method of contraception.
3. Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1.
4. Have a history of status epilepticus that required hospitalization during the 6 months before to Visit 1.
5. Have an unstable psychiatric diagnosis that may confound subjects’ ability to participate in the study or that may prevent completion of the protocol specified tests.
6. Any suicidal ideation with intent with or without a plan within 6 months before Visit 2.
7. Are scheduled or confirmed or both to have epilepsy surgery within 6 months after Visit 1.
8. Evidence of clinically significant disease that in the opinion of the investigator could affect the subject’s safety or interfere with the study assessments.
9. Evidence of moderate or severe renal insufficiency as defined by estimated glomerular filtration rates (eGFRs).
10. Evidence of significant active hepatic disease.
11. Evidence of significant active hematological disease.
12. Clinically significant ECG abnormality, including Fridericia prolonged corrected QT interval (QTcF) defined as greater than 450 msec.
13. Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
14. Multiple drug allergies or a severe drug reaction to AEDs, including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
15. Concomitant use of felbamate as an AED for less than 2 years or where the dose has not been stable for at least 8 weeks before Visit 1.
16. Concomitant or recent (within last 5 months before Visit 1) use of vigabatrin or any evidence of vigabatrin-associated clinically significant vision abnormality.
17. Benzodiazepines for any indications other than epilepsy prohibited from 1 month before Visit 1 and during the study.
18. A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS) implanted less than 5 months before Visit 1 or changes in parameter less than 4 weeks before Visit 1 (or thereafter during the study).
19. On a ketogenic diet for which the diet is not stable regimen for at least 4 weeks before to Visit 1.
20. History of or a concomitant medical condition that in the opinion of the investigator would preclude the subject’s participation in a clinical study or compromise the subject’s ability to safely complete the study.
21. Use of perampanel within 30 days before Visit 1, or perampanel was discontinued due to adverse reactions (perampanel-related) or lack of efficacy in case of previous exposure.
22. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
23. Have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1.
24. Hypersensitivity to the active substance or to any of the excipients of the study drug

1. Mujeres en período de lactancia o embarazadas en el período de selección o basal.
2. Mujeres en edad fértil que:
•En los 28 días previos a la incorporación al estudio no hayan utilizado un método anticonceptivo muy eficaz
•No se comprometan a utilizar un método anticonceptivo muy eficaz
3. Presencia o antecedentes de seudocrisis (crisis no epilépticas psicógenas) aproximadamente en los 5 años previos a la visita 1.
4.Antecedentes de estado epiléptico con necesidad de hospitalización en los 6 meses previos a la visita 1.
5.Diagnóstico psiquiátrico inestable que pueda confundir la capacidad del sujeto para participar en el estudio o que pueda impedir la realización de las pruebas especificadas en el protocolo .
6.Ideación suicida con intención, con o sin un plan, en los 6 meses previos a la visita 2
7.Cita prevista o confirmada para una intervención quirúrgica por epilepsia en los 6 meses siguientes a la visita 1;
8. Signos de enfermedad de importancia clínica que, en opinión del investigador, pueda afectar a la seguridad del sujeto o interferir en las evaluaciones del estudio.
9.Signos de insuficiencia renal moderada o grave, definida por una filtración glomerular estimada (FGe)
10.Signos de hepatopatía activa importante.
11.Signos de enfermedad hematológica activa importante;
12.Alteración clínicamente significativa en el electrocardiograma (ECG), como un intervalo QT corregido (QTc) prolongado, definido como mayor de 450 ms.
13.Enfermedad progresiva del sistema nervioso central (SNC), como enfermedades degenerativas y tumores progresivos.
14.Múltiples alergias a medicamentos o reacción grave a un antiepiléptico, incluidas reacciones dermatológicas (p. ej., síndrome de Stevens-Johnson), hematológicas o de toxicidad orgánica.
15.Uso concomitante de felbamato como antiepiléptico durante menos de 2 años o, en caso de que la dosis no haya sido estable, durante al menos 8 semanas antes de la visita 1.
16.Uso concomitante o reciente (en los 5 meses previos a la visita 1) de vigabatrina o cualquier signo de una anomalía visual clínicamente importante asociada a vigabatrina.
17.Uso intermitente de benzodiacepinas por indicaciones distintas de la epilepsia (p. ej., ansiedad o trastorno del sueño) en el mes previo a la visita 1. Se permite el uso de benzodiacepinas como medicación de rescate para controlar las crisis.
18.Implantación de un estimulador del nervio vago (ENV), neuroestimulador reactivo (NER) o estimulador cerebral profundo (ECP) menos de 5 meses antes de la visita 1 o cambios de los parámetros menos de 4 semanas antes de la visita 1 (o posteriormente durante el estudio).
19.Seguimiento de una dieta cetogénica que no se haya mantenido estable durante al menos 4 semanas antes de la visita 1.
20.Antecedentes o presencia de una enfermedad concomitante que, en opinión del investigador, impida la participación del sujeto en un estudio clínico o comprometa su capacidad de completar el estudio de forma segura.
21.Uso de perampanel en los 30 días previos a la visita 1 o suspensión de perampanel por reacciones adversas (relacionadas con perampanel) o falta de eficacia en caso de exposición previa.
22.Problemas hereditarios de intolerancia a la galactosa, alactasia lapona o malabsorción de glucosa-galactosa.
23.Participación en un estudio en el que se haya administrado un fármaco o producto sanitario en investigación en las 4 semanas previas a la visita 1, o en el período equivalente a unas 5 semividas del compuesto en investigación anterior, lo que suponga más tiempo.
24. Hipersensibilidad a sustancias activas o a cualquier excipiente del farmaco del estudio

E.5 End points

E.5.1

Primary end point(s)

Proportion of 50% responders for all seizures.

Proporción de sujetos con respuesta del 50 % en todas las crisis

E.5.1.1

Timepoint(s) of evaluation of this end point

23 weeks

23 semanas

E.5.2

Secondary end point(s)

1. Proportion of subjects who are seizure-free.
2. Absolute and Percent Change from baseline in seizure frequency for all seizures.
3. CGI of Change.
4. SGI of Change.
5. Change from baseline in CDR.
6. Change from baseline in CBCL.
7. Proportion of responders for all seizures.
8. Changes from baseline in growth and development parameters.
9. Proportion of subjects with any treatment-emergent reports of suicidal ideation and behavior on the C-SSRS and intensity of these behaviors assessed using C-SSRS scores.
10. Change from baseline in number of seizures recorded on EEG.
11. Safety and tolerability

1.Proporción de sujetos que se queden sin crisis .
2.Variación absoluta y porcentual con respecto al período basal de la frecuencia de todas las crisis
3. Puntuación CGI-C (según el investigador) al final del período de tratamiento del estudio principal y al final de la fase de extensión.
4. Puntuación SGI-C (según el sujeto) al final del período de tratamiento del estudio principal y al final de la fase de extensión.
5. Variación de la puntuación CDR entre el período basal .
6.Variación de la puntuación CBCL entre el período basal .
7.Proporción de sujetos con respuesta en todas las crisis .
8.Variaciones de los parámetros de crecimiento y desarrollo entre el periodo basal.
9.Proporción de sujetos con cualquier notificación de ideación y comportamiento suicidas en la escala C SSRS surgidos durante el tratamiento e intensidad de estos comportamientos evaluada mediante las puntuaciones C-SSRS .
10.Variación del número de crisis registradas en el EEG entre el período basal.
11. Seguridad y tolerabilidad

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 23 & 52 weeks
2. 23 & 52 weeks
3. 23 & 52 weeks
4. 23 & 52 weeks
5. 23 & 52 weeks
6, 23 & 52 weeks
7. 23 & 52 weeks
8. Continuous
9. 23 & 52 weeks
10. 23 & 52 weeks
11. Continuous

1. 23 & 52 semanas
2. 23 & 52 semanas
3. 23 & 52 semanas
4. 23 & 52 semanas
5. 23 & 52 semanas
6, 23 & 52 semanas
7. 23 & 52 semanas
8. Continuo
9. 23 & 52 semanas
10. 23 & 52 semanas
11. Continuo

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

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

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Belgium

Czech Republic

Denmark

France

Germany

Spain

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit of the last subject.

Ultima 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 years

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:

100

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subjects are infants & toddlers, children and adolescents.

Los sujetos son lactantes y niños pequeños, niños y adolescentes

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

100

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)

Expected normal treatment.

Tratamiento normal esperado

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

2019-09-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-08-09

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

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