Clinical Trials Register

Summary
EudraCT Number:	2016-005082-31
Sponsor's Protocol Code Number:	MP-TAP-2016-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-01-04
Trial results

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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2016-005082-31

A.3

Full title of the trial

Assessment of Tapentadol effects on patients with pain central sensitization using functional MRI

Evaluación del efecto de tapentadol en pacientes con dolor por sensibilización central utilizando la resonancia magnética funcional (fMRI)

A.3.1

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

Assessment of Tapentadol effects on patients with pain central sensitization using functional MRI

Evaluación del efecto de tapentadol en pacientes con dolor por sensibilización central utilizando la resonancia magnética funcional (fMRI)

A.4.1

Sponsor's protocol code number

MP-TAP-2016-01

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	MRI Research Unit, Radiology Department. Hospital del Mar.
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	Grunenthal Pharma S.A.
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	MRI Research Unit, Radiology Department. Hospital del Mar.
B.5.2	Functional name of contact point	Jesus Pujol
B.5.3	Address:
B.5.3.1	Street Address	Passeig Marítim, 25-29,
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08003
B.5.3.4	Country	Spain
B.5.5	Fax number	34932483259
B.5.6	E-mail	21404jpn@comb.cat

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	Palexia retard 50 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Grünenthal Pharma S.A.
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.3.1	Product name	Palexia Retard
D.3.4	Pharmaceutical form	Prolonged-release 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	Tapentadol Hydrochloride
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	TAPENTADOL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB32145
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)	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	Palexia retard 100 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Grünenthal Pharma S.A.
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.3.1	Product name	Palexia retard
D.3.4	Pharmaceutical form	Prolonged-release 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	Tapentadol Hydrochloride
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	TAPENTADOL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB32145
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	100
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	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	Palexia retard 150 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Grünenthal Pharma S.A.
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.3.1	Product name	Palexia retard
D.3.4	Pharmaceutical form	Prolonged-release 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	Tapentadol Hydrochloride
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	TAPENTADOL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB32145
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	150
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: 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	Palexia retard 200 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Grünenthal Pharma S.A.
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.3.1	Product name	Palexia retard
D.3.4	Pharmaceutical form	Prolonged-release 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	Tapentadol Hydrochloride
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	TAPENTADOL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB32145
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)	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: 5
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	Palexia retard 250 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Grünenthal Pharma S.A.
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.3.1	Product name	Palexia retard
D.3.4	Pharmaceutical form	Prolonged-release 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	Tapentadol Hydrochloride
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	TAPENTADOL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB32145
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	250
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
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients suffering from pain due to knee osteoarthritis

Pacientes con dolor por artrosis de rodilla

E.1.1.1

Medical condition in easily understood language

Patients suffering from pain due to knee osteoarthritis

Pacientes con dolor por artrosis de rodilla

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

This study aimed at demonstrating, by means of functional MRI (fMRI), the effect of Tapentadol on brain response to knee painful stimulation in knee osteoarthritis patients with clinical evidence of central sensitization.

El objetivo de este estudio es demostrar, mediante fMRI, el efecto de tapentadol en la respuesta cerebral al dolor en la rodilla mediante estimulación dolorosa debido a artrosis de rodilla en pacientes con evidencia clínica de sensibilización central.

E.2.2

Secondary objectives of the trial

• To investigate Tapentadol effects on functional connectivity during brain resting-state in centrally sensitized patients. This is a methodologically new exploratory approach under development in the MRI Research Unit of Hospital del Mar in Barcelona. The team has achieved relevant recent results (Pujol et al 2014a,b,c, 2015, 2016; Lopez-Sola et al. 2104, Contreras-Rodríguez et al. 2014, Blanco-Hinojo 2016).

• To assess the relationships between Tapentadol effects on brain response to painful stimulation and Tapentadol effects on clinical parameters.

• Investigador los efectos de tapentadol en la conectividad funcional durante el estado de reposo del cerebro en pacientes con sensibilización central. Esto es un abordaje metodológicamente nuevo en desarrollo por el Servicio de Radiología del Hospital del mar de Barcelona. Este equipo ha logrado resultados relevantes recientemente en este área (Pujol et al 2014a,b,c, 2015, 2016; Lopez-Sola et al. 2104, Contreras-Rodríguez et al. 2014, Blanco-Hinojo 2016).

• Evaluar la relación entre el efecto de tapentadol en la respuesta cerebral a la estimulación dolorosa y los efectos de tapentadol en parámetros clínicos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. A diagnosis of knee OA and suitable for the study as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
2. Have a radiological and clinical diagnosis of knee OA based upon American College of Rheumatology (ACR) criteria (1986) affecting at least one knee of a minimum of 3 months in symptom duration prior to screening.
3. Central sensitization as defined by a positive clinical evidence of pain central sensitization affecting the knee combined with a minimum of 2 tender points around the affected knee experimentally verified using pain thresholds (Arendt-Nielsen et al. 2010, Graven-Nielsen et al. 2010, Woolf 2011, Imamura et al. 2008, Nijs et al. 2010).
4. Patients with Brief Pain Inventory (BPI) item 5 score of 6-10 points
5. Subject is either male or female and at least 45 years of age.
6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
7. Patients capable to be treated according to the technical specifications of summary of product characteristics (SmPC).

1. Presentar el paciente un diagnóstico de artrosis de rodilla y ser adecuado para el studio según el investigador responsable, basado en la evaluación médica incluyendo historial médico, examen físico, test de laboratorio y monitorización cardiaca.
2. Tener un diagnóstico clínico y radiológico de artrosis de rodilla basado en los criterios del Colegio Americano de Reumatología [American College of Rheumatology (ACR) (1986) con un mínimo de 3 meses con síntomas previos a la selección.
3. Sensibilización central definida por una evidencia positive de dolor por sensibilización central afectando a la rodilla, combinado con al menos dos puntos de sensibilidad alrededor de la rodilla afectada, verificado experimentalmente utilizando umbrales de dolor (Arendt-Nielsen et al. 2010, Graven-Nielsen et al. 2010, Woolf 2011, Imamura et al. 2008, Nijs et al. 2010).
4. Pacientes con una puntuación de 5 ítems sobre 6-10 puntos en el Inventario Breve del Dolor [Brief Pain Inventory (BPI)]
5. Sujetos mujeres o varones con al menos una edad de 45 años.
6. Ser capaz de dar su consentimiento informado, que incluye la adherencia a los requerimientos y a lista de restricciones indicadas en el consentimiento informado.
7. Pacientes indicados para el tratamiento con las características técnica de la Ficha Técnica.

E.4

Principal exclusion criteria

1. A female subject is eligible to participate if she is of non-childbearing potential.
2. Body weight >120kg.
3. Severe or non-stable medical conditions.

1. Mujeres elegibles a participar si presentan un potencial de edad fértil.
2. Peso corporal >120kg.
3. Condición médica grave y no estable

E.5 End points

E.5.1

Primary end point(s)

Brain response to knee painful stimulation (endpoint) will be obtained by applying direct pulsed pressure stimulation on the painful knee and pulsed pressure stimulation on a non-arthritic hyperalgesic area (i.e., the anterior tibial surface of the leg).

La respuesta cerebral a la estimulación dolorosa en la rodilla (variable primaria) será obtenida aplicando directamente estimulación por presión pulsada en la rodilla dolorosa y estimulación por presión pulsada en el área hiperalgésica no artrósica (por ejemplo, en la superficie de la tibia anterior de la pierna).

E.5.1.1

Timepoint(s) of evaluation of this end point

Each patient will participate in a total of 3 treatment conditions: tapentadol, placebo and no treatment, after which an MRI exam will be administered in each case (14-21 days after each treatment condition ends).

Cada paciente participará en 3 condiciones de tratamiento: tapentadol, placebo y sin tratamiento, después de cada una, se realizará una MRI (14-21 días después de la finalización de cada condición)

E.5.2

Secondary end point(s)

Pain threshold
Temporal summation
Brief Pain Inventory (BPI)
Hospital Anxiety and Depression (HADS)
PainDETECT
WOMAC

Umbral del Dolor
Sumación temporal
Brief Pain Inventory (BPI)
Hospital Anxiety and Depression (HADS)
PainDETECT
WOMAC

E.5.2.1

Timepoint(s) of evaluation of this end point

14-21 days after each treatment condition ends

14-21 días después de la finalización de cada condición

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

E.6.5

Efficacy

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

Yes

E.6.13.1

Other scope of the trial description

brain response to the treatment

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

The duration of each treatment phase will be 14 days and the time between treatments will be 14-21 days, with a total duration of the study of 112 days.
A subject may terminate participation in the trial at any time without providing a reason and without any personal disadvantage. Additionally, the investigators can stop the participation of a subject after consideration of the benefit/risk ratio.

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.1.6

Adolescents (12-17 years)

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)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

None

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

2017-11-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-10

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

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