Clinical Trials Register

Summary
EudraCT Number:	2011-002362-21
Sponsor's Protocol Code Number:	14178A
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-08
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-002362-21

A.3

Full title of the trial

A randomised, double-blind, parallel-group, active-controlled, flexible dose study evaluating the effects of Lu AA21004 versus agomelatine in adult patients suffering from major depressive disorder with inadequate response to antidepressant treatment

Studio randomizzato, in doppio cieco, a gruppi paralleli, controllato con principio attivo, a dosi flessibili, per la valutazione degli effetti di Lu AA21004 rispetto ad agomelatina in pazienti adulti affetti da disturbo depressivo maggiore con risposta inadeguata al trattamento antidepressivo

A.3.1

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

A study of the new pharmaceutical LuAA21004 in comparison to agomelatine in adults suffering from major depression who did not respond well to previous medication.

Uno studio di un nuovo composto farmaceutico LuAA21004 in confronto a agomelatina in adulti affetti da depressione maggiore che non hanno risposto bene ai precedenti farmaci.

A.4.1

Sponsor's protocol code number

14178A

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	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	H. Lundbeck A/S
B.5.2	Functional name of contact point	LundbeckClinicalTrials@lundbeck.com
B.5.3	Address:
B.5.3.1	Street Address	Ottiliavej 9
B.5.3.2	Town/ city	Valby, Copenhagen
B.5.3.3	Post code	2500
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+45 36 301311
B.5.5	Fax number	+45 36 301940
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	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 AA21004
D.3.2	Product code	Lu AA21004
D.3.4	Pharmaceutical form	Capsule
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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	Lu AA21004
D.3.9.3	Other descriptive name	Lu AA21004
D.3.9.4	EV Substance Code	NA
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: 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	Valdoxan
D.2.1.1.2	Name of the Marketing Authorisation holder	Les Laboratoires Servier
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	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	NA
D.3.9.1	CAS number	138112-76-2
D.3.9.2	Current sponsor code	AGOMELATINA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB05286MIG
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)	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	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 AA21004
D.3.2	Product code	Lu AA21004
D.3.4	Pharmaceutical form	Capsule
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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	Lu AA21004
D.3.9.3	Other descriptive name	Lu AA21004
D.3.9.4	EV Substance Code	NA
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.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	Valdoxan
D.2.1.1.2	Name of the Marketing Authorisation holder	Les Laboratoires Servier
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	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	NA
D.3.9.1	CAS number	138112-76-2
D.3.9.2	Current sponsor code	AGOMELATINA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB05286MIG
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.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 (MDD)

Disordini Depressivi Maggiori (MDD)

E.1.1.1

Medical condition in easily understood language

Depression

Depressione

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	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

To compare the efficacy of flexible doses of Lu AA21004 (10 to 20 mg/day) versus flexible doses of agomelatine (25 to 50 mg/day) after 8 weeks of treatment, on depressive symptoms in patients with Major Depressive Disorder (MDD) who have responded inadequately to Serotonin Reuptake Inhibitor (SRI) antidepressant monotherapy.

 Confrontare, dopo 8 settimane di trattamento, l’efficacia di dosi flessibili di Lu AA21004 (da 10 a 20 mg/giorno) rispetto a dosi flessibili di agomelatina (da 25 a 50 mg/giorno) nei confronti dei sintomi depressivi in pazienti affetti da disturbo depressivo maggiore (MDD) con risposta inadeguata agli antidepressivi SRI (inibitori della ricaptazione della serotonina).

E.2.2

Secondary objectives of the trial

To compare: • The efficacy of flexible doses of Lu AA21004 (10 to 20 mg/day) versus flexible doses of agomelatine (25 to 50 mg/day) over the 12 weeks of treatment on Depressive symptoms • The safety and tolerability of flexible doses of Lu AA21004 (10 to 20 mg/day) versus flexible doses of agomelatine (25 to 50 mg/day) over the 12 weeks of treatment
Exploratory objectives are described in the protocol

 Confrontare l’efficacia di dosi flessibili di Lu AA21004 (da 10 a 20 mg/giorno) rispetto a dosi flessibili di agomelatina (da 25 a 50 mg/giorno) nel periodo di trattamento di 12 settimane nei confronti di:  Sintomi depressivi  Confrontare la sicurezza e la tollerabilità di dosi flessibili di Lu AA21004 (da 10 a 20 mg/giorno) rispetto a dosi flessibili di agomelatina (da 25 a 50 mg/giorno) nel periodo di trattamento di 12 settimane. Obiettivi di tipo esplorativo sono descritti nel protocollo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• The patient is a man or woman, between 18 and 75 years old (inclusive) • The patient is being treated with an SRI antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria) • The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline • MADRS total score ≥22 at the Screening Visit and Baseline • The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception • Other protocol-defined inclusion criteria may apply

1. Pazienti in grado di leggere e comprendere il modulo di consenso informato. 2. Pazienti che abbiano firmato il modulo di consenso informato. Non può essere eseguita nessuna procedura correlata allo studio prima che i pazienti abbiano firmato il modulo. 3. Pazienti disposti e in grado di presentarsi agli appuntamenti dello studio entro le finestre temporali specificate. 4. Pazienti che, alle visite di screening e basale, siano trattati con un antidepressivo SRI in monoterapia (citalopram, escitalopram, paroxetina, sertralina, duloxetina, venlafaxina) prescritto per gestire un singolo episodio di MDD (codice di classificazione 296.2x) o MDD ricorrente (codice di classificazione 296.3x) secondo la diagnosi primaria e i criteri del DSM-IV-TR™. 5. Pazienti che presentino sintomi depressivi attualmente considerati non responsivi o solo parzialmente responsivi a non più di un trattamento adeguato (dosi approvate per almeno 6 settimane prima della visita di screening) con SRI in monoterapia (citalopram, escitalopram, paroxetina, sertralina, duloxetina, venlafaxina) e che, nel giudizio dello sperimentatore, siano idonei al passaggio a un altro farmaco. 6. Pazienti che abbiano espresso il desiderio di interrompere il trattamento con SRI a causa della risposta inadeguata e accettino di sospendere l’antidepressivo SRI attuale in occasione della visita basale e per l’intera durata dello studio. 7. Pazienti che presentino un punteggio totale MADRS ≥ 22 alle visite di screening e basale. 8. Pazienti che presentino un punteggio di almeno 3 nella voce 1 (umore apparente) della scala MADRS alle visite di screening e basale. 9. Pazienti la cui durata riferita dell’MDE in corso sia inferiore a 1 anno alla visita di screening. 10. Pazienti di entrambi i sessi e di età compresa tra ≥ 18 (o in base alla legislazione locale) e ≤ 75 anni. 11. Pazienti ricoverati in un ospedale psichiatrico o trattati ambulatorialmente da una struttura psichiatrica al momento dell’ingresso nello studio. 12. Donne che:  accettino di non iniziare una gravidanza durante lo studio, E utilizzino un metodo anticoncezionale adeguato e altamente efficace. Altri criteri di inclusione definiti dal protocollo devono essere applicati.

E.4

Principal exclusion criteria

• The patient has any current Axis I disorders (DSM-IV criteria) other
than MDD, GAD and SAD
• The patient is at significant risk of suicide
• The patient is currently receiving formal psychotherapy or
otherpsychoactive medications
Other protocol-defined exclusion criteria may apply

. Pazienti con qualsiasi disturbo psichiatrico o disturbo dell’asse I in atto (criteri del DSM-IV-TR™), diverso da disturbo d’ansia generalizzata (GAD) e disturbo d’ansia sociale (SAD)
. Pazienti a rischio significativo di suicidio
. Pazienti che stiano attualmente ricevendo una psicoterapia formale o altri farmaci psicoattivi.
. Altri criteri di esclusione definiti dal protocollo devono essere applicati.

E.5 End points

E.5.1

Primary end point(s)

The change in MADRS total score from baseline to Week 8

Variazione del punteggio totale MADRS rispetto al basale dopo 8 settimane di trattamento

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline and Week 8

Basale e 8 Settimane

E.5.2

Secondary end point(s)

Change from baseline to Weeks 1, 2, 3, 4 and 12 in the MADRS total score

Cambiamenti dal Basale alle Settimane 1, 2, 3, 4 e 12 nel punteggio totale MADRS

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline and Weeks 1, 2, 3, 4 and 12

Basale e Settimane 1, 2, 3, 4, e 12

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

proteomics and metabolomics

proteomico e metabolomico

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

Croatia

Russian Federation

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 overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study.

La fine globale dello studio è definita come l'ultimo contatto specificato dal protocollo con l'ultimo paziente attivo nello studio.

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

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

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:

395

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

105

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

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

369

F.4.2.2

In the whole clinical trial

500

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)

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-02-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-13

P. End of Trial
P.	End of Trial Status	Completed

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