Clinical Trials Register

Summary
EudraCT Number:	2010-021860-13
Sponsor's Protocol Code Number:	BIA-91067-301
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:	2010-10-27
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

2010-021860-13

A.3

Full title of the trial

EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.
EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS

A.3.2

Name or abbreviated title of the trial where available

BIPARK STUDY I

A.4.1

Sponsor's protocol code number

BIA-91067-301

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	BIAL - Portela & Ca, S.A.
B.1.3.4	Country	Portugal
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	BIA 9-1067
D.3.2	Product code	BIA 9-1067
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	BIA 9-1067
D.3.9.1	CAS number	923287-50-7
D.3.9.2	Current sponsor code	BIA 9-1067
D.3.9.3	Other descriptive name	BIA 9-1067
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	50
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	Comtan®
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Pharmaceuticals
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	Over-encapsulated Entacapone Tablets
D.3.2	Product code	Over-encapsulated Entacapone Tablets
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	ENTACAPONE
D.3.9.1	CAS number	130929-57-6
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	200
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	BIA 9-1067
D.3.2	Product code	BIA 9-1067
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	BIA 9-1067
D.3.9.1	CAS number	923287-50-7
D.3.9.2	Current sponsor code	BIA 9-1067
D.3.9.3	Other descriptive name	BIA 9-1067
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	25
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	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	BIA 9-1067
D.3.2	Product code	BIA 9-1067
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	BIA 9-1067
D.3.9.1	CAS number	923287-50-7
D.3.9.2	Current sponsor code	BIA 9-1067
D.3.9.3	Other descriptive name	BIA 9-1067
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.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	Capsule*
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

Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.
Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis

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	10061536
E.1.2	Term	Parkinson's disease

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 investigate the efficacy of 3 different doses of BIA 9-1067 (5 mg, 25 mg, and 50 mg) administered once a day, compared with 200 mg of entacapone or placebo, when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations.

E.2.2

Secondary objectives of the trial

To investigate the safety and tolerability of the combined treatment (L DOPA/DDCI plus BIA 9-1067, entacapone, or placebo).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

V1 (Selección, hasta 14 días antes de la V2)
1. Ser capaces de comprender y estar dispuesto a firmar el consentimiento informado.
2. Ser varón o mujer con edades comprendidas entre los 30 y los 83 años de edad, ambas incluidas.
3. Diagnosis de EP idiopática de acuerdo con los Criterios Diagnósticos Clínicos del Banco de Cerebros de la Sociedad de la Enfermedad de Parkinson del Reino Unido durante al menos 3 años.
4. Gravedad de la enfermedad en Estadios I-III (escala modificada de Hoehn & Yahr) en ON.
5. En tratamiento con L-DOPA/IDDC durante al menos 1 año con clara mejoría clínica según el criterio del investigador.
6. En tratamiento con de 3 a 8 dosis diarias de L-DOPA/IDDC, que puede incluir una formulación de liberación retardada.
7. En régimen estable de L-DOPA/IDDC y otros fármacos anti-EP durante al menos 4 semanas antes de la selección.
8. Presentar signos del fenómeno de 'wearing off' (deterioro fin de dosis) durante al menos las 4 semanas antes de la selección, con una media total diaria de periodos OFF de al menos 1.5 horas durante el periodo de vigilia, excluyendo la primera dosis OFF de la mañana, a pesar de recibir una terapia anti-EP óptima (según el criterio del investigador).
9. Ser capaz de llevar un diario fiable de las fluctuaciones motoras (por sí solo o con ayuda de un familiar/cuidador).
10. Amenorreica durante al menos 1 año o haber sido esterilizada quirúrgicamente durante al menos 6 meses antes de la selección. Las mujeres en edad fértil deben usar un método eficaz anticonceptivo no hormonal.

V2 (Aleatorización, Día 0)
11. Haber rellenado las tablas del diario de auto-puntuación de acuerdo con las instrucciones para ello y con 3 o menos errores al día.
12. Presentar al menos 1.5 horas al día en estado OFF, excluyendo el primer periodo OFF de la mañana antes de la primera dosis (es decir, el tiempo entre despertar y la respuesta a la primera dosis de L-DOPA/IDDC), registrado en el diario de auto-puntuación durante al menos 2 de los 3 días precedentes a la V2.
13. El investigador considera aceptables los resultados de las pruebas de laboratorio del periodo de selección (es decir, no son clínicamente relevantes para el bienestar del sujeto o para el objetivo del estudio).

E.4

Principal exclusion criteria

V1 (Selección, hasta 14 días antes de la V2)
1. EP no idiopática (parkinsonismo atípico, parkinsonismo secundario [adquirido o sintomático], síndrome de Parkinson Plus).
2. Puntuación de discapacidad por discinesia >3 en la Escala Unificada de Puntuación de la Enfermedad de Parkinson (UPDRS), subsección IV A, punto 33.
3. Periodos OFF severo y/o impredecibles.
4. Tratamiento con medicación prohibida: tolcapona, neurolépticos, venlafaxina, inhibidores de la MAO (a excepción de selegilina hasta 10 mg/día en formulación oral o 1.25 mg/día en formulación por absorción bucal o rasagilina hasta 1 mg/día), o antieméticos con acción antidopaminérgica (a excepción de domperidona) en el mes anterior a la selección.
5. Uso previo de entacapona.
6. Tratamiento con apomorfina, alfa-metildopa o reserpina en el mes anterior a la selección o probabilidad de que lo vaya a necesitar en algún momento durante el estudio.
7. Haber realizado un cambio de dosis en la medicación anti-EP concomitante en las 4 semanas anteriores a la selección.
8. Estimulación cerebral profunda previa o programada (durante todo el estudio, incluido durante el periodo AB).
9. Haber sido sometido a una cirugía estereotáctica previa (p. ej., palidotomía, talamotomía) por EP o cirugía estereotáctica planeada durante el periodo del estudio.
10. Haber recibido cualquier PEI en los 3 meses (o en un plazo de 5 vida medias del PEI, lo que sea más largo) antes de la selección.
11. Sufrir cualquier afección médica que pudiera aumentar el riesgo del sujeto o interferir con las evaluaciones.
12. Historia médica actual o antecedentes (durante el último año) de ideas suicidas o de intentos de suicidio.
13. Diagnóstico actual o previo (en el último año) de trastorno depresivo mayor, manía, trastorno bipolar, psicosis, distimia, trastorno de ansiedad generalizada, alcoholismo o abuso de sustancias, excluidas la cafeína y la nicotina, trastornos de control del impulso (p. ej. ludopatía), demencia o trastornos de la alimentación de acuerdo con el Manual Diagnóstico y Estadístico de los Trastornos Mentales, 4ª Edición, revisión del texto (DSM-IV) de la Asociación Americana de Psiquiatría, criterios del año 2000, a criterio del investigador.
14. Presentar una anomalía clínicamente relevante en el ECG (en caso necesario, la relevancia será evaluada por un cardiólogo).
15. Presentar signos actuales de enfermedad cardiovascular inestable, incluidos, entre otros, hipertensión no controlada, infarto de miocardio con disfunción sistólica o diastólica importante, angina inestable, insuficiencia cardíaca congestiva (clase mayor o igual a III de la New York Heart Association) y arritmia cardíaca significativa (bloqueo AV de grado 2 o 3 de Mobitz o cualquier otra arritmia que produzca repercusiones hemodinámicas como bradicardia sintomática o síncope).
16. Trasplante renal previo o actualmente en diálisis renal.
17. Feocromocitoma, paraganglioma u otras neoplasias secretoras de catecolaminas.
18. Hipersensibilidad conocida a los ingredientes del PEI utilizados.
19. Antecedentes de síndrome neuroléptico maligno (SNM) o síndromes similares al SNM o rabdomiolisis no traumática.
20. Antecedentes de una enfermedad neoplásica, o presentar un cáncer actualmente, que, en opinión del investigador, excluiría al sujeto del estudio (p. ej., melanoma, cáncer de próstata).
21. Glaucoma de ángulo estrecho inestable y activo o glaucoma de ángulo ancho inestable.
22. Antecedentes o signos actuales de una enfermedad relevante en el contexto de este estudio, es decir, con respecto a la seguridad del sujeto o en relación con las afecciones del estudio, que, por ejemplo, podría afectar a la absorción o el metabolismo del PEI (tal como una hepatopatía relevante).
23. Estar embarazada o en periodo de lactancia.

V2 (Aleatorización, Día 0)
24. Cualquier anomalía en las enzimas hepáticas (alanina aminotransferasa y/o aspartato aminotransferasa) > 2 veces el límite superior del intervalo normal en los resultados de las pruebas de laboratorio de la selección.
25. Niveles de sodio en plasma < 130 mmol/l, recuento de leucocitos < 3000 células/mm3 o cualquier otra anomalía analítica relevante en los resultados de las pruebas de laboratorio de la selección, que, en opinión del investigador, puedan comprometer la seguridad del sujeto.
26. Cumplimiento inadecuado de la medicación concomitante, L-DOPA/IDDC y otros fármacos anti-EP, durante el periodo de selección.

E.5 End points

E.5.1

Primary end point(s)

Criterios de evaluación:
Eficacia:
• Las tablas del diario del sujeto para los periodos ON/OFF.
• Secciones de la UPDRS I (ON), II (ON y OFF) y III (ON)
• Escala modificada de Hoehn & Yahr (ON) (UPDRS V).
• Escala de Schwab y England (ON y OFF) (UDPRS VI).
• Cambios en la dosis de L-DOPA/IDDC.
• Evaluación de cambio realizada por el investigador y por el sujeto.
• Escala del sueño para la enfermedad de Parkinson (PDSS).
• Complicaciones de la terapia (Subsecciones IV A, B y C de la UPDRS).
• Cuestionario sobre la enfermedad de Parkinson (PDQ-39).
• Escala de síntomas no motores (NMSS).
Seguridad:
• Acontecimientos adversos aparecidos durante el tratamiento (AAAT), incluidos los acontecimientos adversos graves. Los AAAT se definen como todos los AA con inicio o empeoramiento después de la primera administración del PEI hasta 2 semanas (14 días) después de la última dosis del PEI (PSV).
• Análisis clínicos de seguridad:
-Bioquímica: sodio, potasio, cloruro, calcio, fosfato, glucosa, creatinina, nitrógeno ureico en sangre, aspartato aminotransferasa, alanina aminotransferasa, gammaglutamil transferasa, fosfatasa alcalina, creatina fosfoquinasa, lactato deshidrogenasa, albúmina, proteínas totales, colesterol total, colesterol de lipoproteínas de alta y baja densidad, triglicéridos, bilirrubina total y bilirrubina directa/indirecta.
-Hematología: recuento de glóbulos rojos, hematocrito, hemoglobina, recuento de glóbulos blancos (total y con fórmula diferencial), recuento de plaquetas.
-Coagulación: tiempo de protrombina (índice normalizado internacional y tiempo de tromboplastina parcial activada).
-Prueba de embarazo en suero y orina: sólo en mujeres en edad fértil.
-Análisis de orina: pH, densidad, proteínas, sangre, glucosa, cetonas, bilirrubina, urobilinógeno (en tira reactiva, local).
• Exploraciones físicas y constantes vitales.
• Exploraciones neurológicas.
• ECG de 12 derivaciones.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

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

double-blind period followed by open label period

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

100

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

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

provided in the protocol

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)	Yes
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	No
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	60
F.4.2	For a multinational trial
F.4.2.1	In the EEA	400
F.4.2.2	In the whole clinical trial	550

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

2011-01-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-12-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-17

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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