Clinical Trials Register

Summary
EudraCT Number:	2009-017024-82
Sponsor's Protocol Code Number:	HSJD-EPEP09
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:	2009-11-17
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

2009-017024-82

A.3

Full title of the trial

Clinical and neuropsychological factors associated with second generation antipsychotic response in patients diagnosed with first episode of early onset schizophrenia spectrum disorders

Factores clínicos y neuropsicológicos asociados a la respuesta a antipsicóticos de segunda generación en pacientes diagnosticados de primer episodio del espectro esquizofrénico de inicio precoz.

A.3.1

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

Clinical and neuropsychological factors associated with second generation antipsychotic response in patients diagnosed with first episode of early onset schizophrenia spectrum disorders

Factores clínicos y neuropsicológicos asociados a la respuesta a antipsicóticos de segunda generación en pacientes diagnosticados de primer episodio del espectro esquizofrénico de inicio precoz.

A.4.1

Sponsor's protocol code number

HSJD-EPEP09

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FUNDACIÓN SANT JOAN DE DEU
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fondo de Investigación Sanitaria del Instituto de Salud Carlos III.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fundació Sant Joan de Deu
B.5.2	Functional name of contact point	Dña. Rosa María Morales
B.5.3	Address:
B.5.3.1	Street Address	C/ Sant Rosa, 39-057 4ª Edificio Docente
B.5.3.2	Town/ city	Espluges de Llobregat
B.5.3.3	Post code	08950
B.5.3.4	Country	Spain
B.5.4	Telephone number	34936009751n/a
B.5.5	Fax number	34936009771n/a
B.5.6	E-mail	rmorales@fsjd.org

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	INVEGA® 3 mg COMPRIMIDOS LIBERACIÓN PROLONGADA
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	Pharmaceutical form	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.3.9.1	CAS number	144598-75-4
D.3.9.3	Other descriptive name	PALIPERIDONE
D.3.9.4	EV Substance Code	SUB23268
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)	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	ABILIFY® 5 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	OTSUKA PHARMACEUTICAL EUROPE LTD.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	Pharmaceutical form	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	ARIPIPRAZOLE
D.3.9.1	CAS number	129722-12-9
D.3.9.4	EV Substance Code	SUB05564MIG
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	5
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: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	HALDOL COMPRIMIDOS DE 5 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	HALDOL
D.3.4	Pharmaceutical form	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.3.9.1	CAS number	52-86-8
D.3.9.3	Other descriptive name	HALOPERIDOL
D.3.9.4	EV Substance Code	SUB08005MIG
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	5
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

First episode of early onset schizophrenia spectrum disorders

Primer episodio del espectro esquizofrénico de inicio precoz.

E.1.1.1

Medical condition in easily understood language

N/A

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10040705
E.1.2	Term	Simple schizophrenia
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

To compare the efficacy of paliperidone, aripiprazole and haloperidol for episodes of Early Onset Schizophrenia Spectrum (EOSS) disorders, as reflected by treatment response at the end of the acute stage of the trial (first 8 weeks) and all cause treatment discontinuation during the 28 weeks of the study.

Comparar la eficacia de paliperidona, aripiprazol y haloperidol para episodios de Espectro Esqizofrénico de Inicio Precoz (EEIP), en función de la respuesta al tratamiento al final de la primera fase del ensayo (primeras 8 semanas), así como la discontinuación por cualquier causa durante las 28 semanas del estudio.

E.2.2

Secondary objectives of the trial

1. To compare the therapeutic efficacy of the three antipsychotic agents on other clinically relevant outcomes, including psychotic symptoms and adaptive and neurocognitive functioning.
2. To compare the safety and tolerability of these three agents.
3. To examine the relationship between the steady-state plasma drug levels and clinical response and/or adverse events at weeks 4, 8, and 28.

1. Comparar la eficacia terapéutica de los tres fármacos antipsicóticos en otros resultados relevantes clínicamente, incluidos síntomas psicóticos, funcionamiento adaptativo y neurocognitivo.
2. Comparar la seguridad y tolerabilidad de los tres fármacos.
3. Examinar la relación entre las concentraciones plasmáticas del fármaco en sangre en estado estacionario y la respuesta clínica y / o los acontecimientos adversos, en las semanas 4, 8, y 28.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients of both sexes, aged 8 to 19 years, both inclusive.
2. Score of at least moderate severity on one of the positive psychotic symptom ratings of the PANSS or BPRS-C.
3. Meet DSM-IV criteria for first episode of schizophrenia, schizophreniform, schizoaffective disorder.
4. Patients with reproductive potential will use an effective birth control method during the entire duration of the trial. Women of reproductive age will be included after a negative pregnancy test result.
5. Informed consent of parents or legal guardian and informed assent of a mature minor.

1. Pacientes de ambos sexos, de 8 a 19 años de edad, ambos inclusive.
2. Puntuación de al menos gravedad moderada en 1 de las evaluaciones de los síntomas psicóticos positivos de PANSS o BPRS-C.
3. Reunir los criterios del DSM-IV para primer episodio de esquizofrenia, trastorno esquizofreniforme, esquizoafectivo.
4. Los sujetos con potencial reproductor realizarán un método efectivo de control de natalidad durante todo el estudio. Las mujeres en edad reproductora se incluirán tras la negatividad de la prueba de embarazo.
5. Consentimiento informado de los padres o representante legal, y asentimiento informado del menor maduro.

E.4

Principal exclusion criteria

1. History of appropriate treatment with paliperidone, aripiprazole or haloperidol (defined as at least 8 weeks of treatment with doses of paliperidone 12 mg/d, aripiprazole 30 mg/d, haloperidol 8 mg/d during the final 2 weeks of treatment) during current psychotic episode.
2. History of appropriate antipsychotic treatment (8-16 weeks) with the study drugs during a previous episode.
3. Hypersensitivity to paliperidone, aripiprazole or haloperidol or presence of any contraindications to start any of these treatments depending on technical data sheet.
4. Bipolar disorder, primary posttraumatic stress disorder, primary personality disorder, diagnosed by a doctor and confirmed by KID-SCID
5. Current major depressive disorder that is clearly defined and therefore excludes diagnosis of EOSS.
6. Premorbid diagnosis of mental retardation
7. Endocrinological or neurological conditions that confound the diagnosis or are a contraindication to treatment (concurrent organic disease that is clearly defined and therefore excludes diagnosis of EOSS).
8. Pregnant or breastfeeding

1. Historial de ensayo adecuado de paliperidona, aripiprazol o haloperidol (definido como al menos 8 semanas de tratamiento con dosis de paliperidona 12 mg/d, aripiprazol 30 mg/d, haloperidol 8 mg/d en las 2 semanas últimas de tratamiento) durante el episodio psicótico actual.
2. Historial de ensayo antipsicótico adecuado (de 8 a 16 semanas) de fármaco en estudio durante un episodio anterior, definido del mismo modo.
3. Hipersensibilidad a paliperidona, aripiprazol o haloperidol o presencia de alguna contraindicación para iniciar cualquiera de estos tratamientos según la ficha técnica.

4. Trastorno bipolar, trastorno de estrés postraumático primario, trastorno de la personalidad primario, diagnosticados por un médico y confirmados por KID-SCID.
5. Episodio depresivo grave actual, claramente definido y que, por tanto, excluye el diagnóstico de EEIP.
6. Diagnóstico premórbido de deficiencia mental.
7. Problemas endocrinos o neurológicos que hagan confuso el diagnóstico o estén contraindicados para el tratamiento (patología orgánica concurrente claramente definida y que, por tanto, excluya el diagnóstico EEIP);
8. Embarazo o lactancia.

E.5 End points

E.5.1

Primary end point(s)

The therapeutic benefits of the three study drugs will be assessed by the Positive and Negative Symptom Scale (PANSS, Kay et al, 1987) and the Clinical Global Impressions-Improvement (CGI-I) scale (NIMH, 1985) at the end of the acute stage (first 8 weeks).
Treatment response will be considered as a 20% reduction in the baseline PANSS score plus a CGI-I score of < 2 at the end of the 8-week acute stage (a score of 1 being very much improved and 2 much improved).
This definition captures both overall and specific symptom improvement and is similar to the response criteria used by Sikich et al. (2004), which were used as preliminary data for this Project. The responder status of the subjects who withdrew from the study before 8 weeks were determined at the time of withdrawal.
Kaplan-Meier survival curves will be used to estimate the rates of all cause treatment discontinuation during the 28 study weeks

Los beneficios terapéuticos de los tres fármacos en estudio se valorarán mediante la Escala de síntomas positivos y negativos (PANSS, Kay et al, 1987) y la escala CGI-I (Escala Clínica Global de Impresión de Mejoría), al final de la primera fase del ensayo (primeras 8 semanas).
La respuesta al tratamiento se valorará como una reducción del 20% en la puntuación basal de la Escala PANSS + una puntuación < 2 de la escala CGI-I (NIMH, 1985) en dicho momento temporal (siendo 1 mucha mejora y 2 bastante mejora).
Esta definición captura tanto las mejoras globales como las de síntomas específicos, y es similar a los criterios de respuesta usados Sikich et al. (2004), que se usaron como datos preliminares para este proyecto. El estatus de respondedor de los individuos que abandonaron el estudio antes de 8 semanas se determinó en el momento del abandono.
Las tasas de discontinuación por cualquier causa durante las 28 semanas del estudio se analizarán empleando las curvas de supervivencia de Kaplan-Meier.

E.5.1.1

Timepoint(s) of evaluation of this end point

End of trial week 28

Al la terminación del estudio semana 28

E.5.2

Secondary end point(s)

1. Psychiatric symptoms will be assessed using the PANSS (Kay et al., 1987) and the BPRS-C (Overall and Pfefferbaum, 1982). The CGI scale (Guy, 1976) will assess the severity of illness (CGI-SI) and improvement of the clinical symptoms (CGI-I).
2. To compare the safety and tolerability of the three agents, the following were assessed:
- potential adverse events using the Monitoring of Side Effects Scale ? Kalachnik, 2001;
- extrapyramidal side effects (EPSEs), using the Simpson Angus Extrapyramidal Symptom Scale (Simpson and Angus, 1970), the Barnes Akathisia Scales (Barnes, 1989) and the Abnormal Involuntary Movement Scale (National Institute of Mental Health, 1985).
- weight gain, metabolic parameters (fasting biochemistry, blood count, glucose, free fatty acids, leptin, insulin, haemoglobin A1c, C-peptide, C-reactive protein, total cholesterol, HDL and LDL cholesterol, triglycerides, and prolactin), cardiac functioning (ECG ? corrected QT), hepatic functioning (AST,ALT) and renal functioning (urinary ionogram, microalbumin in urine).
3.To examine the relationship between steady-state drug blood levels and clinical response (CGI-I, PANSS, BPRS-C) and adverse events at weeks 4, 8, and 28.

1. La sintomatología psiquiátrica se evaluará usando las escalas PANSS (Kay et al., 1987) y BPRS-C (Overall and Pfefferbaum, 1982). La escala CGI (Guy, 1976) valorará la gravedad (CGI-SI) y la mejoría (CGI-I) del cuadro clínico.
2 .Para la comparación de la seguridad y tolerabilidad de los tres agentes se valorarán:
- los acontecimientos adversos potenciales mediante la escala de control de efectos secundarios (Monitoring of Side Effects Scale ? Kalachnik, 2001);
- los efectos secundarios extrapiramidales (ESEP), mediante la Escala de síntomas extrapiramidales de Simpson-Angus (Simpson Angus Extrapyramidal Symptom Scale ? Simpson and Angus, 1970), las escalas de acatisia de Barnes (Barnes Akathisia Scales ? Barnes, 1989) y la escala de Movimientos Anormales Involuntarios (Abnormal Involuntary Movement Scale ? Nacional Institute of Mental Health, 1985).
- el aumento de peso, parámetros metabólicos (bioquímica en ayunas, recuento hemático, glucosa, ácidos grasos libres, leptina, insulina, hemoglobina A1c, C-peptida, proteína C reactiva,colesterol total, colesterol HDL y LDL, triglicéridos, y prolactina), funcionamiento cardiaco (ECG -QT corregido), hepático (AST,ALT) y renal (Ionograma urinario, microalbúmina en orina).
3. Se valorará también la relación entre las concentraciones del fármaco en sangre en estado estacionario y la respuesta clínica (CGI-I, PANSS, BPRS-C) en las semanas 4,8 y 28, y los acontecimientos adversos.

E.5.2.1

Timepoint(s) of evaluation of this end point

End of trial week 28

Al la terminación del estudio semana 28

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

Last patient last visit

La última visita 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

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)

Yes

F.1.2.1

Number of subjects for this age range:

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

Patients will be collected anInformed consent of parents or legal guardian and informed assent of a mature minor.

A los pacientes se les presentará un Consentimiento informado de los padres o representante legal, y asentimiento informado del menor maduro yotal ante testigo

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)

N/A

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

2012-01-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-08-01

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

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