Clinical Trials Register

Summary
EudraCT Number:	2017-000559-26
Sponsor's Protocol Code Number:	PRAG-MS
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-09-30
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-000559-26

A.3

Full title of the trial

A multicentric randomized PRAGmatic trial to compare the effectiveness of fingolimod versus dimethyl-fumarate on patient overall disease experience in relapsing remitting Multiple Sclerosis:
novel data to inform decision-makers – (PRAG-MS)

A.3.1

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

A multicentric, international study in order to compare the effectiveness of fingolimod versus dimethyl-fumarate on patients with Multiple Sclerosis.

Studio multicentrico, internazionale volto a confrontare l'efficacia di fingolimod e dimetil-fumarato in pazienti con Sclerosi Multipla

A.3.2

Name or abbreviated title of the trial where available

PRAG-MS

A.4.1

Sponsor's protocol code number

PRAG-MS

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	FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
B.1.3.4	Country	Italy
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	Patient-Centered Outcomes Research Institute
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS Istituto Neurologico Carlo Besta
B.5.2	Functional name of contact point	Servizio Ricerca e Sviluppo Clinico
B.5.3	Address:
B.5.3.1	Street Address	via Celoria 11
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390223942321
B.5.5	Fax number	+390270638217
B.5.6	E-mail	presidenza@istituto-besta.it

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	GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE - BLISTER DIVISIBILE PER DOSE UNITARIA(PVC/PVDC/ALU) SCATOLA DA 7X1 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS EUROPHARM LTD
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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, hard
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	FINGOLIMOD
D.3.9.1	CAS number	162359-55-9
D.3.9.2	Current sponsor code	FINGOLIMOD
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	0
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	TECFIDERA - 240 MG - CAPSULA RIGIDA GASTRORESISTENTE - USO ORALE - BLISTER (PVC/PE/PVDC-PVC ALLUMINIO) - 56 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	BIOGEN IDEC LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Gastro-resistant capsule, hard
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	DIMETIL-FUMARATO
D.3.9.1	CAS number	624-49-7
D.3.9.2	Current sponsor code	DIMETIL
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	240
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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

relapsing-remitting multiple sclerosis

sclerosi multipla recidivante-remittente

E.1.1.1

Medical condition in easily understood language

multiple sclerosis

sclerosi multipla

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10063399
E.1.2	Term	Relapsing-remitting multiple sclerosis
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10029205
E.1.2	Term	Nervous system disorders
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10063399
E.1.2	Term	Relapsing-remitting multiple sclerosis
E.1.2	System Organ Class	10029205 - Nervous system 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 effectiveness of fingolimod 0.5 mg once daily versus dimethyl-fumarate 240 mg twice daily in their ability to maintain the NEDA status over 24 months in RRMS patients.
The NEDA status is satisfied when all the three following criteria are fullfilled:
1. no clinical relapse
2. no new or enlarged T2 lesions or T1 gadolinium-enhanced lesions at the MRI
3. no neurological progression of the clinical status evaluated by means of EDSS

confrontare l’efficacia di fingolimod 0.5 mg/die versus dimetilfumarato 240 mg 2 volte/die nel mantenere lo stato di Non Evidenza di Attività di Malattia.
Lo stato di Non Evidenza di Attività di Malattia è soddisfatto dai seguenti criteri:
- assenza di ricadute cliniche,
- assenza di nuove lesioni in T2 o lesioni attive in T1 alla RM
- assenza di progressione di disabilità valutata con la scala EDSS

E.2.2

Secondary objectives of the trial

to compare the effectiveness of the two oral Disease Modifying Treatments (DMTs) in terms of
1. prevention of clinical relapses over 12 and 24 months
2. prevention of MRI activity over 12 and 24 months
3. prevention of brain atrophy over 12 and 24 months
4. prevention of sustained disability progression (EDSS worsening) over 24 months¿
5. prevention of perceived sustained disability progression (patient-reported disability worsening) over 24 months¿
6. prevention of objective sustained disability progression assessed by inertial sensors over 12 and 24 months¿
7. patient-NEDA (no patient-reported EDSS worsening, no clinical relapse, no MRI activity, preservation of quality of life) over 24 months
8. prevention of cognitive decline over 12 and 24 months¿
9. preservation of quality of life over 12 and 24 months
10. convenience perception over 12 and 24 month¿
11. psychiatric symptoms and fatigue over 12 and 24 months

confrontare l’efficacia dei due trattamenti in termine di:
1. prevenzione di ricadute cliniche a 12 e 24 mesi
2. prevenzione di attività radiologica a 12 e 24 mesi
3. prevenzione di atrofia cerebrale a 12 e 24 mesi
4. prevenzione di confermato peggioramento di disabilità misurata con EDSS nei 24 mesi di follow-up
5. prevenzione di soggettivo peggioramento di disabilità riportato dal paziente nei 24 mesi di follow-up
6. prevenzione di oggettivo peggioramento di disabilità misurata da sensori inerziali a 12 e 24 mesi
7. NEDA riportato dal paziente (nessun peggioramento di disabilità riportato dal paziente, nessuna ricaduta clinica, nessuna nuova lesione alla RM, preservazione della qualità di vita)
8. prevenzione di declino cognitivo a 12 e 24 mesi
9. preservazione di qualità di vita a 12 e 24 mesi
10. percezione di convenienza a 12 e 24 mesi
11. sintomi psichiatrici e fatica a 12 e 24 mesi

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Pharmacogenetics
Version: 1.0
Date: 10/02/2017
Title: Ancillary study of pharmacogenomic –Pharmacogenetic Test
Objectives: To investigate the associations between baseline genetic features and selected clinical endpoints over 12 and 24 months of treatment. Exploratory DNA research studies are planned with the objectives of identifying genetic factors which may (1) be related to MS, (2) predict response to treatment, (3) predict genetic predisposition to side effects.

Pharmacogenomics
Version: 1.0
Date: 10/02/2017
Title: Ancillary study of pharmacogenomic – Gene Expression and response profile Test
Objectives: To investigate the change in gene expression profile during treatments; to investigate the association between change in gene expression after 6 months of treatment and clinical endpoints at 12 and 24 months

Life quality
Version: 1.0
Date: 10/02/2017
null
Objectives: to investigate the efficacy of the treatments in preserving quality of life and preventing cognitive decline. Specific aim of this substudy is evaluating the individualized quality of life

Other types of substudies
Specify title, date and version of each substudy with relative objectives: - Immunological ancillary study (v. 1.0 dated ): to evaluate the Changes in cytokine profile and distribution of T and B cell subpopulation over 6, 12 and 24 months of treatment; to investigate the Associations between baseline immunological features and selected clinical endpoints over 12 and 24 months of treatment; association between change in peripheral cytokines and cell distribution and clinical endpoints at 12 and 24 months;
- Gait analysis ancillary study (v. 1.0 dated ):
To assess disability with wearable inertial sensors; to compare the effectiveness of the two oral DMTs in terms of prevention of objective sustained disability progression assessed by inertial sensors over 12 and 24 months

Farmacogenetica
Versione: 1.0
Data: 10/02/2017
Titolo: Studio ancillare di farmacogenomica - Test di farmacogenetica
Obiettivi: investigare l’associazione tra varianti genetiche e endpoint clinici a 12 e 24 mesi. il sottostudio mira a identificare fattori genetici che possono essere correlati alla sclerosi multipla (1), predire la risposta al trattamento (2), predire effetti collaterali (3).

Farmacogenomica
Versione: 1.0
Data: 10/02/2017
Titolo: Studio ancillare di farmacogenomica - Test di espressione genica e profilo di risposta
Obiettivi: investigare il cambiamento di espressione genica in corso di trattamento; investigare l’associazione tra cambiamento di espressione espressione genica a 6 mesi ed endpoint clinici a 12 e 24 mesi

Qualita' della vita
Versione: 1.0
Data: 10/02/2017
Titolo: Studio Ancillare Psicologico e Neuropsicologico
Obiettivi: valutare l’efficacia dei trattamenti nel preservare la qualità della vita e nel prevenire declino cognitivo. Specifico scopo di questo sottostudio è valutare la qualità della vita individualizzata.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: - studio ancillare di immunologia (v. 1.0 del ): valutare cambiamenti nel profilo citochinico e nella distribuzione delle sotto-popolazioni linfocitarie in corso di trattamento; investigare l’associazione tra caratteristiche immunologiche al baseline ed endpoint clinici a 12 e 24 mesi; investigare l’associazione tra cambiamento nel profilo citochinico e nella distribuzione delle sotto-popolazioni linfocitarie e risposta clinica al trattamento;
- studio ancillare per l’analisi del cammino (v. 1.0 del ): misurare la disabilità con sensori inerziali; confrontare l’efficacia dei due trattamenti nel prevenire la progressione di disabilità misurata con sensori inerziali a 12 e 24 mesi;

E.3

Principal inclusion criteria

adult patients diagnosed with relapsing remitting multiple sclerosis who are eligible to both fingolimod and dimethyl-fumarate treatment as for local authority indications and clinical judgement could be enrolled in the study.

pazienti adulti con sclerosis multipla recidivante remittente eliggibili al trattamento sia con fingolimod che con dimetil-fumarato per indicazioni prescrittive locali e per giudizio clinic; consenso informato scritto

E.4

Principal exclusion criteria

• any FTY/DMF contraindication, as for authorized indications or clinical judgment
• present immunodeficiency syndrome (primary or secondary immune deficiency)
• severe chronic active infections or acute infections not resolved at the time of the enrolment
• evidence of active tuberculosis (TB)
• history of either untreated or inadequately treated latent TB infection. Adequate treatment for latent TB is defined according to local country guidelines for immunocompromised subjects.
• Progressive Multifocal Leukoencephalopathy, even if only suspected
• active malignancies
• severe liver impairment (Child-Pugh class C)
• hypersensitivity to the active substances or to any of the excipients
• Pregnancy or breastfeeding.

- qualsiasi controindicazione a fingolimod o dimetil-fumarato
- immunodeficienza
- infezioni severe croniche attive o infezioni acute
- tubercolosi attiva
- tubercolosi latente non trattata adeguatamente
- leucoencefalopatia multifocale progressiva
- tumori maligni
- grave danno epatico
- ipersensibilità alla sostanza attiva o agli eccipienti
- gravidanza o allattamento

E.5 End points

E.5.1

Primary end point(s)

The time for losing the NEDA status

Tempo di perdita dello stato NEDA

E.5.1.1

Timepoint(s) of evaluation of this end point

12 and 24 months

a 12 e a 24 mesi

E.5.2

Secondary end point(s)

Annual relapse rate; Number of Gd+ MRI Lesion; Brain volume loss; Percentage of patients with confirmed increase of 1 point on PDDSS; Percentage of patients with a confirmed increase of 1 point on the EDSS scale; Change in gait performance assessed by inertial sensors; Percentage of patients maintaining patients-NEDA status; 8. Change in cognitive impairment index (CII) assessed by Brief Repeatable Battery of Neuropsychological tests (BRB-N), in social cognition assessed by Story based Empathy task (SET), and in quality of decision making assessed by Game of Dice Task (GDT) ; 9. Change in health related Qol assessed by EuroQOL-5D (EQ-5D) and The Multiple Sclerosis Quality-of-Life-54 (MSQOL-54) and in individualized Qol assessed by The SEIQoL-DW ; Convenience perception as measured by the convenience scale within TSQM-9 ; Symptomatic changes as determinated by Modified Fatigue Impact Scale (MFIS) and Hospital Anxiety & Depression Scale (HADS)

tasso annuale di ricadute; Il numero di lesioni Gd+ alla risonanza ; Perdita del volume cerebrale ; Percentuale di pazienti con un incremento confermato di 1 punto sulla scala PDDSS; percentuale di pazienti con un incremento confermato di 1 punto sulla scala EDSS ; Variazioni della performance nel cammino valutato con sensori inerziali; Percentuale di pazienti che mantengono lo stato NEDA riportato dal paziente; Variazione nell'indice di disfunzione cognitiva (CII) valutato con la Brief Repeatable Battery dei test neuropsicologici, nella cognizione sociale valutata con la Story based Empathy task, e nella qualità della capacità decisionale valutata con il game of Dice task; variazioni nella qualità di vita concernente la salute valutata con EuroQoL-5D e il MSQoL-54 e la qualità della vita individuale valutata con il SEIQoL-DW; percezione della convenienza come misurata dalla scala di convenienza presente all'interno del TSQM-9; Variazioni sintomatiche come determinato dalla MFIS e dalla HADS

E.5.2.1

Timepoint(s) of evaluation of this end point

over 12 and 24 months; at 12 and 24 months; at 12 and 24 months; over 24 months; over 24 months; over 12 and 24 months; over 24 months; at 12 and 24 months; over 12 and 24 months; over 12 and 24 months; over 24 months

a 12 e 24 mesi; a 12 e 24 mesi; a 12 e 24 mesi; fino a 24 mesi; fino a 24 mesi; a 12 e 24 mesi; fino a 24 mesi; a 12 e 24 mesi; fino a 12 e 24 mesi; fino a 12 e 24 mesi; fino a 24 mesi

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

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

biomarkers study

studio biomarcatori

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

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

Israel

United States

Switzerland

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

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.1.1.1

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:

900

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

1000

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

1360

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)

Patients will be followed as for normal clinical practice in term of treatments and visits

I soggetti saranno seguiti secondo normale pratica clinica in termini di trattamento e visite successive

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

2017-09-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-08

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

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