Clinical Trials Register

Summary
EudraCT Number:	2009-018161-12
Sponsor's Protocol Code Number:	SPD503-315
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-11-24
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

2009-018161-12

A.3

Full title of the trial

A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention deficit/Hyperactivity Disorder Estudio de Fase 3, doble ciego, controlado con placebo, multicéntrico, de mantenimiento a largo plazo y retirada aleatorizada, de la eficacia y seguridad de Clorhidrato de Guanfacina de liberación prolongada en niños y adolescentes de 6 a 17 años con Trastorno por Déficit de Atención con Hiperactividad

A.4.1

Sponsor's protocol code number

SPD503-315

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Shire Development Inc
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	INTUNIV
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire Development Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Guanfacine Hydrochloride
D.3.2	Product code	SPD503
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	GUANFACINE HYDROCHLORIDE
D.3.9.1	CAS number	29110-48-3
D.3.9.2	Current sponsor code	SPD503
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	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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	INTUNIV
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire Development Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Guanfacine Hydrochloride
D.3.2	Product code	SPD503
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	GUANFACINE HYDROCHLORIDE
D.3.9.1	CAS number	29110-48-3
D.3.9.2	Current sponsor code	SPD503
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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: 3
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	INTUNIV
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire Development Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Guanfacine Hydrochloride
D.3.2	Product code	SPD503
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	GUANFACINE HYDROCHLORIDE
D.3.9.1	CAS number	29110-48-3
D.3.9.2	Current sponsor code	SPD503
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	3
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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: 4
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	INTUNIV
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire Development Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Guanfacine Hydrochloride
D.3.2	Product code	SPD503
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	GUANFACINE HYDROCHLORIDE
D.3.9.1	CAS number	29110-48-3
D.3.9.2	Current sponsor code	SPD503
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	4
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Attention-Deficit/Hyperactive Disorder (ADHD)
Trastorno por déficit de atención con hiperactividad

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10064104
E.1.2	Term	ADHD

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10068451
E.1.2	Term	ADHD, combined type

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10068452
E.1.2	Term	ADHD, predominantly hyperactive-impulsive type

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10068453
E.1.2	Term	ADHD, predominantly inattentive type

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El análisis principal de la eficacia se realizará sobre las tasas de fracaso terapéutico durante la fase a doble ciego de retirada aleatorizada en la población del CAC aleatorizado mediante una prueba de Cochran-Mantel-Haenszel (CMH) estratificada por grupo de edad y por país. Los sujetos que abandonen el estudio por cualquier motivo durante la fase de retirada aleatorizada serán clasificados como fracaso terapéutico.
La hipótesis nula sostiene que no existe diferencia en la tasa de fracaso terapéutico entre el SPD503 y el placebo, con una alternativa bilateral de una diferencia distinta de cero entre los grupos.

E.2.2

Secondary objectives of the trial

1. Evaluar la eficacia a largo plazo del SPD503 a partir de la puntuación total de la Escala ADHD-RS-IV administrada por el facultativo.
2. Evaluar la eficacia a largo plazo del SPD503 mediante la escala CGI-S o Clinical Global Impressions-Severity of Illness, cumplimentada por el facultativo.
3. Evaluar la eficacia del SPD503 mediante la escala CGI-I o Clinical Global Impressions-Improvement, cumplimentada por el facultativo.
4. Evaluar la eficacia sobre los resultados funcionales del TDAH mediante la Escala cumplimentada por los padres (WFIRS-P o Weiss Functional Impairment Rating Scale-Parent).
5. Evaluar el impacto del tratamiento sobre la percepción del estado de salud a partir de las escalas HUI-2/3 o Health Utilities Index-Mark 2 and Mark 3.
6. Evaluar la seguridad a largo plazo del SPD503 a partir de los acontecimientos adversos aparecidos durante el tratamiento (AAAT),determinación de la presión arterial y el pulso, análisis de laboratorio, ECGs y la Escala C-SSRS

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Sexo masculino o femenino, edad comprendida entre los 6 y los 17 años en el momento de prestar el consentimiento/asentimiento en la visita 1 o de selección.
2. Criterios de diagnóstico primario de TDAH según el Manual diagnóstico y estadístico de los trastornos mentales, cuarta edición revisada (DSM-IV-TR) del tipo combinado, del tipo con predominio hiperactivo-impulsivo o del tipo con predominio del déficit de atención a partir de un examen psiquiátrico exhaustivo mediante la Kiddie-Escala para trastornos afectivos y esquizofrenia-presente y a lo largo de la vida (K SADS-PL o Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime).
3. Puntuación mínima de 32 en la ADHD-RS-IV en la visita 2 o de inclusión.
4. Puntuación mínima de 4 en la CGI-S en la visita 2 o de inclusión.
5. Capacidad de deglutir comprimidos enteros.

E.4

Principal exclusion criteria

1. Diagnóstico actual de un trastorno psiquiátrico controlado (para el que necesite un medicamento no permitido o programa de modificación de la conducta) o incontrolado excepto el trastorno negativista desafiante (TND) incluyendo cualquier trastorno concomitante grave del eje II o del eje I, como p. ej. el trastorno por estrés postraumático, los trastornos bipolares, las psicosis, los trastornos generalizados del desarrollo, el trastorno obsesivo-compulsivo, los trastornos por consumo de sustancias u otras manifestaciones sintomáticas o antecedentes personales de trastornos bipolares, psicosis o trastornos de la conducta que a juicio del investigador suponga una contraindicación para el tratamiento con SPD503 o dificulte las evaluaciones de eficacia o seguridad.
2. Antecedentes o presencia de malformaciones cardíacas, arritmias graves, síncopes, alteraciones de la conducción cardíaca (p. ej. bloqueo cardíaco de relevancia clínica), episodios cardíacos relacionados con el ejercicio, como síncope o presíncope, o bradicardia de relevancia clínica.
3. Hipotensión ortostática o antecedentes conocidos de hipertensión, controlada o no.
4. Consumo actual de medicamentos no permitidos o productos farmacéuticos o fitoterapéuticos que alteren la presión arterial (PA) o la frecuencia cardíaca, que ejerzan efectos sobre el sistema nervioso central (SNC) o que afecten a la función cognitiva, como los antihistamínicos sedantes y los descongestionantes simpaticomiméticos (se permiten los broncodilatadores por vía inhalatoria), o antecedentes de consumo permanente de medicamentos con efectos sedantes (como antihistamínicos) que contravengan los criterios de lavado fijados por el protocolo para la visita 2/inclusión.
5. Sobrepeso importante según los gráficos del índice de masa corporal por sexo y edad de los Centros para el Control y la Prevención de Enfermedades de los EEUU. Por sobrepeso importante se entiende un IMC > percentil 95.
6. En el caso de los niños de 6-12 años, peso < 25,0 kg; en el caso de los adolescentes de 13-17, peso < 34,0 kg ó > 91,0 kg en la visita 1/selección.
7. Antecedentes de alcoholismo, drogodependencia u otras toxicomanías en los últimos 6 meses (sin contar el tabaquismo), con arreglo a las definiciones del DSM-IV-TR.
8. Riesgo actual de suicidio, según el investigador; antecedentes de intento de suicidio o antecedentes o presencia de ideas suicidas activas. No se excluirá necesariamente a los sujetos con ideas suicidas intermitentes de carácter pasivo, según la evaluación que haga el investigador (consúltese la orientación del protocolo).
9. Antecedentes de ausencia de respuesta a la exposición a un agonista α2 para el tratamiento del TDAH (consistente en un tratamiento con una dosis adecuada y una duración suficiente según determine el investigador).

E.5 End points

E.5.1

Primary end point(s)

El criterio principal de valoración para cada sujeto es el fracaso terapéutico durante la fase a doble ciego de retirada aleatorizada (fase 2), entendido como un aumento (empeoramiento) mayor o igual al 50% de la puntuación total de la ADHD-RS-IV en dos visitas consecutivas de la fase 2 (visitas 14 a 23/FP) respecto a la puntuación de la visita 13 y un aumento mayor o igual a 2 puntos en la CGI-S respecto a la visita 13 en las correspondientes visitas de la fase 2

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

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Open label dose optimisation/maintenance phase followed by randomised withdrawal.

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

Information not present in EudraCT

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

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

Se define final del ensayo con la visita de seguimiento de seguridad 7 días despues de la última dósis del medicamento en investigación del último 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

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.1.1.1

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.1.1.6

Adolescents (12-17 years)

Yes

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-24.

Yes

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

Debido a la edad de los pacientes del ensayo se ha generado un consentimiento para padres/tutores

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

204

F.4.2.2

In the whole clinical trial

510

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)

No se ha previsto ningun cuidado adicional para el paciente trás la finalización del estudio

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

2011-02-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-02-04

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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