Clinical Trials Register

Summary
EudraCT Number:	2011-005249-12
Sponsor's Protocol Code Number:	EFC11759
National Competent Authority:	Greece - EOF
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-05-21
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Greece - EOF

A.2

EudraCT number

2011-005249-12

A.3

Full title of the trial

A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

Πολυκεντρική, τυχαιοποιημένη, διπλά τυφλή, ελεγχόμενη με εικονικό
φάρμακο μελέτη παράλληλων ομάδων διάρκειας δύο ετών για την
αξιολόγηση της αποτελεσματικότητας, της ασφάλειας, της ανοχής και της
φαρμακοκινητικής της άπαξ ημερησίως από στόματος χορηγούμενης
τεριφλουνομίδης σε παιδιατρικούς ασθενείς με υποτροπιάζουσες μορφές
πολλαπλής σκλήρυνσης ακολουθούμενη από ανοικτή επέκταση

A.3.1

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

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

Αποτελεσματικότητα, ασφάλεια και φαρμακοκινητική της τεριφλουνομίδης σε παιδιατρικούς ασθενείς με υποτροπιάζουσες μορφές πολλαπλής σκλήρυνσης

A.3.2

Name or abbreviated title of the trial where available

TERIKIDS

A.4.1

Sponsor's protocol code number

EFC11759

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1124-0983

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/209/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Genzyme Corporation
B.1.3.4	Country	United States
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	Genzyme Corporation
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	Sanofi-aventis AEBE
B.5.2	Functional name of contact point	Aggelina Mavraki
B.5.3	Address:
B.5.3.1	Street Address	Syngrou Av.
B.5.3.2	Town/ city	Kallithea
B.5.3.3	Post code	17674
B.5.3.4	Country	Greece
B.5.4	Telephone number	00302109001659
B.5.5	Fax number	00302109249140
B.5.6	E-mail	Aggelina.Mavraki@sanofi.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	Teriflunomide
D.3.2	Product code	HMR1726
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	TERIFLUNOMIDE
D.3.9.1	CAS number	108605-62-5
D.3.9.4	EV Substance Code	SUB25218
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	14
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	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	Teriflunomide
D.3.2	Product code	HMR1726
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	TERIFLUNOMIDE
D.3.9.1	CAS number	108605-62-5
D.3.9.4	EV Substance Code	SUB25218
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	7
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	Teriflunomide
D.3.2	Product code	HMR1726
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Yes
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	TERIFLUNOMIDE
D.3.9.1	CAS number	108605-62-5
D.3.9.4	EV Substance Code	SUB25218
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	3.5
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.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	Film-coated 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

Multiple Sclerosis

Πολλαπλή Σκλήρυνση

E.1.1.1

Medical condition in easily understood language

Multiple Sclerosis

Πολλαπλή Σκλήρυνση

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	20.1
E.1.2	Level	PT
E.1.2	Classification code	10028245
E.1.2	Term	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 assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.

Η αξιολόγηση της επίδρασης της τεριφλουνομίδης σε σύγκριση με το
εικονικό φάρμακο στη δραστηριότητα της νόσου όπως μετράται από το χρόνο έως την πρώτη κλινική υποτροπή μετά την τυχαιοποίηση σε παιδιά και εφήβους ηλικίας 10 έως 17 ετών με υποτροπιάζουσες μορφές πολλαπλής σκλήρυνσης

E.2.2

Secondary objectives of the trial

To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function.
To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
To evaluate the pharmacokinetics (PK) of teriflunomide.

Η αξιολόγηση της επίδρασης της τεριφλουνομίδης σε σύγκριση με το
εικονικό φάρμακο στη δραστηριότητα/εξέλιξη της νόσου όπως εκτιμάται
με MRI εγκεφάλου και εξετάσεις της γνωστικής λειτουργίας
Η αξιολόγηση της ασφάλειας και της ανοχής της τεριφλουνομίδης σε
σύγκριση με το εικονικό φάρμακο
Η αξιολόγηση της φαρμακοκινητικής (PK) της τεριφλουνομίδης

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Patients with relapsing multiple sclerosis are eligible. Patients should meet the criteria of MS based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 (5) and have:
- at least one relapse (or attack) in the 12 months preceding screening or
- at least two relapses (or attack) in the 24 months preceding screening
-≤18 years of age and ≥10 years of age at randomization. Specific for the Russian Federation from 18 December 2014 to 26 July 2016, ≤17 years of age and ≥13 years of age at randomization
-Signed informed consent/assent obtained from patient and patient’s legal representative (parents or guardians) according to local regulations.

- Ασθενείς με διάγνωση υποτροπιάζουσας ΠΣ με βάση τα κριτήρια
McDonald του 2010 και τα κριτήρια της Διεθνούς Ομάδας Μελέτης
Παιδιατρικής Πολλαπλής Σκλήρυνσης για την παιδιατρική ΠΣ, οι οποίοι:
- έχουν παρουσιάσει τουλάχιστον μία υποτροπή (ή προσβολή) στους 12 μήνες πριν από την προκαταρκτική αξιολόγηση ή
- έχουν παρουσιάσει τουλάχιστον 2 υποτροπές (ή προσβολές) στους 24 μήνες πριν από την προκαταρκτική αξιολόγηση,
- Ηλικία ≤18 ετών και ≥ 10 ετών κατά την τυχαιοποίηση. Ειδικά για τη Ρωσική Ομοσπονδία από 18 Δεκεμβρίου 2014 έως 26 Ιουλίου 2016, ηλικία ≤ 17 ετών και ≥ 13 ετών κατά την τυχαιοποίηση
- Λήψη υπογεγραμμένης συγκατάθεσης/συναίνεσης κατόπιν ενημέρωσης από τον ασθενή ή τον νόμιμο εκπρόσωπο του ασθενούς (γονείς ή κηδεμόνες) σύμφωνα με τους τοπικούς κανονισμούς

E.4

Principal exclusion criteria

• EDSS score > 5.5 at screening or randomization visits
• Relapse within 30 days prior to randomization
• Treated with
- glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization
- fingolimod, or intravenous immunoglobulins within 3 months prior to randomization
- natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization
- cladribine or mitoxantrone within 2 years prior to randomization
• Treated with alemtuzumab at any time
• History of HIV infection
• Contraindication for MRI
• Pregnant or breast-feeding females or those who plan to become pregnant during the study
• Female patients of child-bearing potential not using highly effective contraceptive method (contraception in both female and male is required).

- Βαθμολογία EDSS > 5,5 κατά τις επισκέψεις προκαταρκτικής αξιολόγησης ή τυχαιοποίησης
- Υποτροπή εντός 30 ημερών πριν από την τυχαιοποίηση
- Λήψη θεραπείας με
• οξική γλατιραμέρη, ιντερφερόνες ή φουμαρικό διμεθυλεστέρα εντός 1 μηνός πριν από την τυχαιοποίηση
• φινγκολιμόδη ή ενδοφλεβίως χορηγούμενες ανοσοσφαιρίνες εντός 3 μηνών πριν από την τυχαιοποίηση
• ναταλιζουμάμπη ή άλλοι ανοσοκατασταλτικοί ή ανοσορυθμιστικοί παράγοντες όπως κυκλοφωσφαμίδη, αζαθειοπρίνη, κυκλοσπορίνη, μεθοτρεξάτη, μυκοφαινολάτη εντός 6 μηνών πριν από την τυχαιοποίηση
• κλαδριβίνη ή μιτοξαντρόνη εντός 2 ετών πριν από την τυχαιοποίηση
- Λήψη αλεμτουζουμάμπης οποιαδήποτε στιγμή
- Ιστορικό λοίμωξης από HIV
- Αντένδειξη για MRI
- Έγκυες ή θηλάζουσες γυναίκες ή γυναίκες που σκοπεύουν να μείνουν
έγκυες κατά τη διάρκεια της μελέτης
- Γυναίκες ασθενείς σε αναπαραγωγική ηλικία που δεν χρησιμοποιούν
άκρως αποτελεσματικά αντισυλληπτικά (διπλή μέθοδος φραγμού) ή
μέθοδο αντισύλληψης

E.5 End points

E.5.1

Primary end point(s)

1-Time to first clinical relapse after randomization

Χρόνος έως την πρώτη κλινική υποτροπή μετά την τυχαιοποίηση

E.5.1.1

Timepoint(s) of evaluation of this end point

Over 96 weeks

Περισσότερο από 96 εβδομάδες

E.5.2

Secondary end point(s)

2 - Proportion of relapse free patients
3 - Number of new/newly enlarged T2 lesions
4 - Number of T1 Gd-enhancing T1 lesions
5 - Change in volume of T2 lesions
- Change in volume of T1 hypointense lesions
6 - Number of new T1 hypointense lesions
7 - Proportion of patients free of new or enlarged MRI T2-lesions
8 - Brain atrophy
9 - Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test
10 - Safety, as assessed by clinical, laboratory, ECG, and vital signs events
11 - Teriflunomide pharmacokinetics (PK)

2 - Ποσοστό ασθενών χωρίς υποτροπή
3 - Αριθμός νέων/νεοδιευρυμένων βλαβών T2
4 - Αριθμός βλαβών Τ1 που προσλαμβάνουν γαδολίνιο
5 - Μεταβολή του όγκου των βλαβών T2
- Μεταβολή του όγκου των βλαβών T1 χαμηλής έντασης
6 - Αριθμός νέων βλαβών T1 χαμηλής έντασης
7 - Ποσοστό ασθενών χωρίς νέες ή διευρυμένες MRI T2 βλάβες
8 - Εγκεφαλική ατροφία
9 - Μεταβολή στην απόδοση στη Δοκιμασία Κωδικοποίησης Συμβόλων (SDMT) και τη Σειρά Δοκιμασιών Γνωστικής Λειτουργίας
10 -Ασφάλεια, όπως αξιολογείται από την κλινική και εργαστηριακή εξέταση, το ΗΚΓ και τα ζωτικά σημεία
11 - Φαρμακοκινητική (PK) της τεριφλουνομίδης

E.5.2.1

Timepoint(s) of evaluation of this end point

2: at 24, 48, 72 and 96 weeks
3, 4, 5, 6, 8 and 10: over 96 weeks
7: at 48 weeks and 96 weeks
9: at randomization, then every 24 weeks (SDMT only) and at 96 weeks
11: at Weeks 2, 3, 4, 8, 12, 24, 36 and EOT

2: στις 24, 48, 72 και 96 εβδομάδες
3, 4, 5, 6, 8 και 10: Περισσότερο από 96 εβδομάδες
7: στην τυχαιοποίηση, μετά κάθε 24 εβδομάδες (μόνο SDMT) και στις 96 εβδομάδες
11: στις εβδομάδες 2, 3, 4, 8, 12, 24, 36 και ΕΟΤ

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

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

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

Επιλογή να περάσουν σε ανοιχτό σκέλος με τεριφλουνομίδη για ασθενείς

Option to go in an open label teriflunomide arm for patients having a relapse after PK run-in phase

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

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

Australia

Canada

China

Israel

Lebanon

North Macedonia

Morocco

Russian Federation

Serbia

Tunisia

Turkey

Ukraine

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

Tελευταία επίσκεψη τελευταίου ασθενούς

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:

165

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:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

132

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

10-17 years of age for this study; patients will give assents and parents or legal guardian will give consents

Ηλικία 10-17 ετών για αυτή τη μελέτη. Οι ασθενείς θα συναινέσουν και
οι γονείς ή ο ασκών τη νόμιμη γονική επιμέλεια θα συγκαταθέσουν

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

F.4.2.2

In the whole clinical trial

165

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

2014-07-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-27

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

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:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials