Clinical Trials Register

Summary
EudraCT Number:	2008-005356-25
Sponsor's Protocol Code Number:	12712A
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:	2016-04-20
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

2008-005356-25

A.3

Full title of the trial

Long-term, open-label, flexible-dose, extension study of vortioxetine in child and adolescent patients with Major Depressive Disorder (MDD) from 7 to 18 years of age

Estudio de extensión a largo plazo, abierto y con flexibilidad de dosis de vortioxetina en niños y adolescentes de 7 a 18 años de edad con trastorno depresivo mayor (TDM)

A.3.1

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

A study to evaluate the long-term safety and tolerability of a product named vortioxetine (used in depression) in children and adolescents.

Estudio para evaluar la seguridad y tolerabilidad a largo plazo de un producto llamado vortioxetina (utilizado en depresión) en niños y adolescentes.

A.4.1

Sponsor's protocol code number

12712A

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/190/2015

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	H. Lundbeck A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Lundbeck España S.A.
B.5.2	Functional name of contact point	Lundbeck Clinical Trials
B.5.3	Address:
B.5.3.1	Street Address	Avenida Diagonal 605, 9º
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08028
B.5.3.4	Country	Spain
B.5.4	Telephone number	34900834586
B.5.6	E-mail	LundbeckClinicalTrials@lundbeck.com

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	Brintellix 5 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	H. Lundbeck A/S
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	Film-coated 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	VORTIOXETINE
D.3.9.1	CAS number	508233-74-7
D.3.9.2	Current sponsor code	Lu AA21004
D.3.9.4	EV Substance Code	SUB88928
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: 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	Brintellix 10 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	H. Lundbeck A/S
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	Film-coated 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	VORTIOXETINE
D.3.9.1	CAS number	508233-74-7
D.3.9.2	Current sponsor code	Lu AA21004
D.3.9.4	EV Substance Code	SUB88928
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)	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	Brintellix 15 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	H. Lundbeck A/S
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	Film-coated 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	VORTIOXETINE
D.3.9.1	CAS number	508233-74-7
D.3.9.2	Current sponsor code	Lu AA21004
D.3.9.4	EV Substance Code	SUB88928
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)	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	Brintellix 20 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	H. Lundbeck A/S
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	Film-coated 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	VORTIOXETINE
D.3.9.1	CAS number	508233-74-7
D.3.9.2	Current sponsor code	Lu AA21004
D.3.9.4	EV Substance Code	SUB88928
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	20
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

Major Depressive Disorder

Trastorno depresivo mayor

E.1.1.1

Medical condition in easily understood language

Depression

Depresión

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	19.0
E.1.2	Level	PT
E.1.2	Classification code	10057840
E.1.2	Term	Major depression
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

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a
Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5?) diagnosis of MDD.

Evaluación de la seguridad y tolerabilidad a largo plazo de vortioxetina en niños y adolescentes con Manual Diagnóstico y Estadístico de los Trastornos Mentales, 5ª edición (DSM-5TM) diagnosticados de TDM

E.2.2

Secondary objectives of the trial

Evaluation of the long-term effectiveness of flexible doses of vortioxetine in a range of 5 mg/day to 20 mg/day on:
- depressive symptoms
- clinical global impression
- cognitive function
- functionality

Evaluación de la efectividad a largo plazo de dosis flexibles de vortioxetina en un intervalo de entre 5 mg/día y 20 mg/día sobre:
? los síntomas depresivos;
? la impresión clínica global;
? la función cognitiva;
? la funcionalidad.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- The patient is a male or female child aged > =7 and <12 years or an adolescent aged > =12 and <=18 years in the lead-in study (12709A and 12710A).
- The patient must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
- The patient had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5?.
- The patient is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.

- Pacientes, niños o niñas, de entre > =7 y <12 años o adolescentes de entre > =12 y <=18 años de edad en el estudio introductorio (12709A and 12710A).
- Pacientes que hayan finalizado el estudio 12709A o 12710A (visita 12, visita de finalización) inmediatamente antes de su inclusión en este estudio de extensión.
- Pacientes con un diagnóstico primario de trastorno depresivo mayor (TDM) en el momento de su entrada al estudio 12709A o 12710A, diagnosticado según el DSM-5?.
- Pacientes para los que está indicado el tratamiento a largo plazo con vortioxetina, según la opinión clínica del investigador.

E.4

Principal exclusion criteria

- The patient has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
- The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

- Pacientes con diagnóstico de otro trastorno psiquiátrico (por ejemplo, manía, trastorno bipolar, esquizofrenia o cualquier trastorno psicótico) durante el estudio 12709A o 12710A.
- Pacientes con trastorno por déficit de atención o hiperactividad (TDAH) que requieran un tratamiento farmacológico que no sea una medicación estimulante.

E.5 End points

E.5.1

Primary end point(s)

Safety:
Safety evaluation based on adverse events, paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and C-SSRS.

Seguridad:
Evaluaciones de seguridad basadas en acontecimientos adversos, escala de puntuación de acontecimientos adversos pediátricos (PAERS), pruebas analíticas de seguridad clínica (incluidas las de las hormonas reproductivas), constantes vitales, peso, estatura , puntuación de Tanner, ciclo menstrual , ECG y C-SSRS.

E.5.1.1

Timepoint(s) of evaluation of this end point

Throughout the study

Durante todo el estudio

E.5.2

Secondary end point(s)

- Change in Children Depression Rating Scale - Revised version (CDRS-R) total score
- Number of relapses (CDRS-R > =40 with a history of 2 weeks of clinical deterioration)
- Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)
- Change in Clinical Global Impression - Severity of Illness (CGI-S) score
- Clinical Global Impression - Global Improvement (CGI-I) score
- Children (7-11 years): Change in Behaviour Rating Inventory of Executive Function (BRIEF) using the Global Executive Composite score
- Children (7-11 years): Change in BRIEF using the Metacognition Index
- Adolescents (12-18 years): Change in Behaviour Rating Inventory of Executive Function - Self-report version (BRIEF-SR) using the Global Executive Composite score
- Adolescents (12-18 years): Change in BRIEF-SR using the Metacognition Index
- Change in Children?s Global Assessment Scale (CGAS) score
- Change in in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) score

- Cambio en la puntuación total de la escala de puntuación de la depresión en niños, versión revisada (CDRS-R)
- Número de recidivas (CDRS-R > =40 con antecedentes de 2 semanas de deterioro clínico)
- Pérdida de remisión (CDRS-R <28 con antecedentes de 2 semanas de deterioro clínico)
- Cambio en la puntuación de la impresión clínica global: gravedad de la enfermedad (CGI-S)
- Puntuación de la impresión clínica global: mejoría global (CGI-I)
- Niños (7 a 11 años): cambio en el inventario de puntuación conductual de la función ejecutiva (BRIEF) usando la puntuación compuesta global de la función ejecutiva
- Niños (7 a 11 años): cambio en BRIEF usando el índice de metacognición
- Adolescentes (12 a 18 años): cambio en el inventario de puntuación conductual de la función ejecutiva autoadministrado (BRIEF-SR) usando la puntuación compuesta global de la función ejecutiva
- Adolescentes (12 a 18 años): cambio en BRIEF-SR usando el índice de metacognición
- Cambio en la puntuación de la escala de evaluación global del niño (CGAS)
- Cambio en la puntuación de las escalas visuales analógicas (EVA) de funcionamiento actual del PedsQL

E.5.2.1

Timepoint(s) of evaluation of this end point

Throughout the study

Durante todo el estudio

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

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

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

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

Austria

Belgium

Bulgaria

Canada

Denmark

Estonia

Finland

France

Germany

Hungary

Ireland

Italy

Latvia

Lithuania

Mexico

Netherlands

Poland

Romania

Russian Federation

Serbia

Slovakia

South Africa

Spain

Sweden

Ukraine

United Kingdom

United States

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

LVLS

LVLS (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:

850

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:

400

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

450

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

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

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Minors

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

281

F.4.2.2

In the whole clinical trial

850

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)

Patient will be treated according to standard medical practice.

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

2016-06-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-03-03

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