Clinical Trials Register

Summary
EudraCT Number:	2008-000479-11
Sponsor's Protocol Code Number:	12396A
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:	2008-07-14
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

2008-000479-11

A.3

Full title of the trial

Estudio aleatorizado, doble ciego, de grupos paralelos y dosis flexibles, controlado con un grupo activo, para evaluar la eficacia y la seguridad del tratamiento con Lu 31-130 durante 12 semanas en pacientes con esquizofrenia

A.3.2

Name or abbreviated title of the trial where available

N/A

A.4.1

Sponsor's protocol code number

12396A

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

N/A

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	H. Lundbeck A/S
B.1.3.4	Country	Denmark
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	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	Lu 31-130
D.3.2	Product code	Lu 31-130
D.3.4	Pharmaceutical form	Capsule*
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.3.9.2	Current sponsor code	Lu 31-130
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)	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	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	Zyprexa 5 mg comprimidos recubiertos
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
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.3.4	Pharmaceutical form	Capsule*
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	OLANZAPINA
D.3.9.1	CAS number	132539061
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	10
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	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	Lu 31-130
D.3.2	Product code	Lu 31-130
D.3.4	Pharmaceutical form	Capsule*
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.3.9.2	Current sponsor code	Lu 31-130
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	7
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	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	ZYPREXA 15 mg comprimidos recubiertos
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
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.3.4	Pharmaceutical form	Capsule*
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	OLANZAPINA
D.3.9.1	CAS number	132539061
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	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)	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Lu 31-130 está en desarrollo por H. Lundbeck A/S como un antipsicótico en el tratamiento de la esquizofrenia

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	PT
E.1.2	Classification code	10039639
E.1.2	Term	Schizophrenia, paranoid type

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	PT
E.1.2	Classification code	10039637
E.1.2	Term	Schizophrenia, catatonic type

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	PT
E.1.2	Classification code	10039638
E.1.2	Term	Schizophrenia, disorganised type

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	PT
E.1.2	Classification code	10052792
E.1.2	Term	Schizophrenia, undifferentiated 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

Evaluar:
- eficacia de Lu 31-130 (5 o 7 mg/día) vs. olanzapina (10 o15 mg/día) después de 12 semanas de tto. según el cambio en la puntuación total PANNS en pacientes con esquizofrenia
- efecto de Lu 31-130 (5 o 7 mg/día) sobre el rendimiento neurocognitivo vs. olanzapina (10 o 15 mg/día) según la batería Brief Assessment of Cognition in Schizophrenia (BACS).
- efectos de Lu 31-130 (5 o 7mg/día) sobre los síntomas depresivos vs. olanzapina (10 o 15 mg/día) utilizando la escala CDSS
- efecto de Lu 31-130 (5 o 7 mg/día) sobre el peso corporal vs. olanzapina (10 o 15 mg/día)
- efecto de Lu 31-130 (5 o 7 mg/día) sobre IMC, perímetro de cintura y variables de lab. tales como las concentraciones séricas de colesterol total, LDL, VLDL, HDL, triglicéridos, HbA1c, y glucosa en ayunas vs. olanzapina (10 o 15 mg/día)
- efecto de Lu 31-130 (5 o 7 mg/día) en las concentraciones séricas de ALAT y ASAT vs. olanzapina (10 o 15 mg/día)

E.2.2

Secondary objectives of the trial

Ninguno

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. El paciente es capaz de leer y entender la Hoja de Información al Paciente.
2. El paciente ha leído el Formulario de Consentimiento Informado.
3. El paciente ha firmado el Formulario de Consentimiento Informado antes de realizar
cualquier procedimiento específico del estudio.
4. El paciente tiene un diagnóstico principal de esquizofrenia de acuerdo con el DSM-IV TR (códigos 295.10, 295.20, 295.30, 295.90).
5. El paciente puede ser de cualquier sexo, con edades comprendidas ente 18 y 65 años (ambas incluidas).
6. El paciente es capaz de comunicarse con el personal del estudio.
7. El paciente tiene una puntuación total PANSS entre 70 y 120 (extremos incluidos) en el Screening 2 y en la visita Basal.
8. El paciente tiene una puntuación CGI-S ≥4 (moderadamente enfermo) en el Screening 1, Screening 2 y visita Basal.
9. El paciente acepta estar hospitalizado durante el periodo desde el Sscreening 2 hasta la visita 5 al menos.
10. En el caso de las pacientes, deben:
− No intentarán quedarse embarazadas durante el estudio Y
− Utilizar un método anticonceptivo adecuado (definido como anticonceptivos orales o sistémicos, dispositivo intrauterino, diafragma en asociación con espermicida, o
preservativo para la pareja masculina en asociación con espermicida) O BIEN
− Ha tenido su última menstruación natural al menos 24 meses antes de la visita Basal, O BIEN
− Se ha esterilizado quirúrgicamente antes de la visita Basal, O BIEN
− Ha sufrido una histerectomía antes de la visita Basal, O BIEN
− No ser sexualmente activas.

E.4

Principal exclusion criteria

1. El paciente tiene en la actualidad un diagnóstico psiquiátrico principal en el Eje I
diferente al de esquizofrenia (criterios DSM-IV TR).
2. El paciente sufre riesgo significativo de suicidio.
3. El paciente ha demostrado conducta violenta en los 12 meses previos al S1.
4. El paciente es resistente al tto antipsicótico.
5. Se ha tratado al paciente con clozapina en los 60 días previos a la S1.
6. El paciente puede tener otros trastornos de conducta, psiquiátricos o neurológicos
(incluso discinesias tardías) que pueden interferir con la realización o interpretación de los resultados del estudio.
7. El paciente tiene diagnóstico en curso, ha tenido un diagnóstico o tiene antecedentes de abuso de sustancias (excepto nicotina, cafeína) o abuso de alcohol basándose en los criterios DSM-IV-TR en los seis meses previos a la S1.
8. Si el paciente da positivo en el chequeo de drogas en el S1 con la excepción de
resultado positivo de opioides, cannabinoides, y benzodiacepinas, el investigador
evaluará el posible efecto sobre la participación en el estudio.
9. El paciente tiene pruebas funcionales hepáticas (es decir, ASAT, ALAT, FA, y
bilirrubina total) dentro del rango de referencia del laboratorio basado en las muestras de sangre extraídas en el S1.
10. El paciente tiene una serología positiva de Hepatitis A (antiVHA IgM), Hepatitis B
(HbsAg), Hepatitis C (VHC), o VIH basándose en las muestras extraídas en el S1.
11. El paciente tiene una afección en curso que puede comprometer la función hepática.
12. El paciente tiene uno o más valores de laboratorio fuera del intervalo de referencia basándose en las muestras de sangre u orina obtenidas en el S1, que los investigadores consideran clínicamente significativos.
13. El paciente está diagnosticado de diabetes mellitus.
14. El paciente tiene antecedentes de traumatismo craneal moderado o grave, u otros trastornos neurológicos y enfermedades generalizadas que afecten el funcionamiento del sistema nervioso central.
15. El paciente tiene antecedentes de síndrome neuroléptico maligno.
16. El paciente tiene antecedentes de hipotiroidismo o hipertiroidismo no corregido.
17. El paciente posee una historia de alergia o hipersensibilidad grave, o de hipersensibilidad conocida u otras contraindicaciones a fármacos serotoninérgicos, antagonistas o agonistas dopaminérgicos.
18. El paciente toma medicación no permitida.
19. El paciente tiene una enfermedad inestable clínicamente significativa.
20. El paciente tiene una enfermedad maligna o una historia de enfermedad maligna, distinta a un carcinoma in situ de cervix o un carcinoma basocelular de la piel correctamente tratados durante los últimos 5 años previos al S1.
21. El paciente tiene signos vitales alterados clínicamente significativos.
22. El paciente tiene hipotensión sintomática o no controlada.
23. El paciente tiene una historia de sincope vasovagal repetido.
24. El paciente tiene un ECG alterado en el S1 que el investigador considera
clínicamente significativo.
25. El paciente tiene un intervalo QTc en el ECG realizado en el S1 por encima de 450 mseg o una historia familiar de síndrome de alargamiento del QT o una historia de hipokaliemia o padece una fallo cardíaco conocido (NYHA II-IV) o si el paciente toma medicación que prolonga el intervalo QTc.
26. El paciente tiene una enfermedad cardíaca isquémica conocida o una historia de infarto de miocardio (dentro de los 12 meses previos), una cirugía de bypass coronario o una angioplastia coronaria percutánea transluminal.
27. El paciente tiene un glaucoma de ángulo cerrado.
28. El paciente tiene una enfermedad o toma una medicación que, en opinión del investigador puede interferir con las evaluaciones de la seguridad, la tolerabilidad o la eficacia.
29. El paciente ha recibido medicación antipsicótica depot en menos del intervalo de dosis previo al S1.
30. El paciente ha recibido TEC en las últimas 12 semanas previas al S1.
31. El paciente ha sido tratado con cualquier medicación en investigación durante los 30 días previos al S1 o 5 veces la vida media del producto en investigación, el que sea más largo.
32. El paciente ha sido expuesto previamente a Lu-31-13.
33. El paciente ha sido tratado con un ciclo adecuado de olanzapina y no respondió o no toleró el fármaco.
34. El paciente ha sido tratado con olanzapina durante los últimos 6 meses previos al
S1.
35. La paciente está embarazada o en periodo de lactancia.
36. El paciente, en opinión del investigador, no es capaz de cumplimentar el protocolo del estudio clínico o no está indicado por cualquier razón.
37. El paciente es un miembro del personal del lugar o sus familiares inmediatos.
38. El paciente está bajo tratamiento obligado y/o hospitalización involuntaria.

E.5 End points

E.5.1

Primary end point(s)

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

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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

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.8.3

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

El final del estudio se define como el último contacto con un paciente especificado por el protocolo. Este podría ser un contacto telefónico 30 días tras la última dosis del fármaco o una visita de seguimiento.
Tras la retirada o la finalización del estudio, el paciente se deberá tratar según la práctica clínica habitual comenzando al día siguinete de la última dosis del fármaco en estudio.

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
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 2008-07-14.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	15
F.4.2	For a multinational trial
F.4.2.1	In the EEA	60
F.4.2.2	In the whole clinical trial	120

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

2008-10-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-07-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-02-06

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