Clinical Trials Register

Summary
EudraCT Number:	2013-002283-25
Sponsor's Protocol Code Number:	EMR200575-001
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:	2013-10-08
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-002283-25

A.3

Full title of the trial

A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis

Studio di fase II, randomizzato, multicentrico, a gruppi paralleli, in cieco per colui che valuta, per valutare l’efficacia, la sicurezza e la tollerabilità di Plovamer Acetato in dosi da 0,5 mg, 3 mg, 10 mg e 20 mg rispetto a Copaxone in pazienti affetti da sclerosi multipla recidivante remittente.

A.3.1

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

A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis

Studio per valutare l’efficacia, la sicurezza e la tollerabilità di Plovamer Acetato rispetto a Copaxone in pazienti affetti da sclerosi multipla recidivante remittente.

A.3.2

Name or abbreviated title of the trial where available

Efficacy, safety, and tolerability of plovamer acetate

Efficacia, sicurezza e tollerabilità di Plovamer Acetato

A.4.1

Sponsor's protocol code number

EMR200575-001

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck KGaA
B.1.3.4	Country	Germany
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	Merck KGaA
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck KGaA
B.5.2	Functional name of contact point	Communication Centre merck KGaA
B.5.3	Address:
B.5.3.1	Street Address	Frankfurterstrasse 250
B.5.3.2	Town/ city	Darmstadt
B.5.3.3	Post code	64293
B.5.3.4	Country	Germany
B.5.4	Telephone number	496151725200
B.5.6	E-mail	service@merckgroup.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	Plovamer acetate
D.3.2	Product code	MSC2491529A
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ND
D.3.9.1	CAS number	ND
D.3.9.2	Current sponsor code	MSC2491529A
D.3.9.3	Other descriptive name	Plovamer acetate
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	Plovamer acetate
D.3.2	Product code	MSC2491529A
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ND
D.3.9.1	CAS number	ND
D.3.9.2	Current sponsor code	MSC2491529A
D.3.9.3	Other descriptive name	Plovamer acetate
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6
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	Plovamer acetate
D.3.2	Product code	MSC2491529A
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ND
D.3.9.1	CAS number	ND
D.3.9.2	Current sponsor code	MSC2491529A
D.3.9.3	Other descriptive name	Plovamer acetate
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	Copaxone
D.2.1.2	Country which granted the Marketing Authorisation	Israel
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Glatiramer acetate
D.3.9.1	CAS number	147245-92-9
D.3.9.3	Other descriptive name	GLATIRAMER ACETATE
D.3.9.4	EV Substance Code	SUB13971MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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

Relapsing Remitting Multiple Sclerosis (RRMS)

sclerosi multipla recidivante remittente (RRMS).

E.1.1.1

Medical condition in easily understood language

Relapsing Remitting Multiple Sclerosis (RRMS)

sclerosi multipla recidivante remittente (RRMS).

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	16.0
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

The primary objective of this trial is to evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg) administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment on the mean number of T1 gadolinium (Gd)-enhancing lesions per patient and scan on brain MRI scans at Weeks 24, 28, 32, 36, and 40 in patients with RRMS.

Valutare l’efficacia di plovamer acetato (0,5 mg, 3 mg, 10 mg e 20 mg) somministrato in iniezioni sottocutanee (s.c.) settimanali rispetto a Copaxone (20 mg) somministrato come iniezione s.c. giornaliera dopo 40 settimane di trattamento sulla base del numero medio di lesioni captanti gadolinio (GD) pesate in T1 per paziente, e della scansione cerebrale mediante risonanza magnetica per immagini (RMI) alle Settimane 24, 28, 32, 36 e 40 in pazienti affetti da sclerosi multipla remittente recidivante (relapsing remitting multiple sclerosis, RRMS).

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg), administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment

Valutare l’efficacia di plovamer acetato (0,5 mg, 3 mg, 10 mg e 20 mg) somministrato in iniezioni s.c. settimanali rispetto a Copaxone (20 mg) somministrato come iniezione s.c. giornaliera s.c. dopo 40 settimane di trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, between the ages of 18 and 60 years.
2. Patient is able to learn and self-administer SC injections (a care-giver may be trained to inject the patient).
3. Patients must have a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria).

Other protocol defined inclusion criteria could apply

1. Pazienti maschi e femmine di età compresa tra 18 e 60 anni
2. Pazienti in grado di apprendere e di auto-somministrarsi iniezioni SC (un care-giver può essere formato per effettuare l’iniezione al paziente).
3. Pazienti con attuale diagnosi di RRMS (in base ai criteri diagnostici MS di McDonald 2010).
Potrebbero essere applicati altri criteri di inclusione definiti dal protocollo.

E.4

Principal exclusion criteria

Patients are not eligible for this trial if they fulfill any of the following exclusion criteria:
1. Any MS categorized as primary progressive, secondary progressive and progressive relapsing.
2. Any relapse of MS within 30 days of the Baseline Visit 2.
3. Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI.
4. Systemic glucocorticoid therapy within 30 days of Baseline Visit 2. Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed.)
5. Contraindication to Copaxone use.

Other protocol defined exclusion criteria could apply

1. Qualsiasi SM classificata come progressiva primaria, secondaria progressiva e
progressiva recidivante.
2. Qualsiasi ricaduta di SM entro 30 giorni dalla visita 2 basale.
3. Allergia al mannitolo, plovamer acetato, Copaxone (glatiramer acetato),
Gd di contrasto per risonanza magnetica.
4. Terapia con glucocorticoidi sistemici entro 30 giorni dalla visita 2 basale. Qualsiasi
requisito per la continua somministrazione di glucocorticoidi sistemici
durante il periodo di prova. (Nota: Il trattamento con interferoni come
Avonex ®, Rebif ®, o Betaseron ® sarà consentito fino alla visita basale,
poichè non è necessario alcun periodo di wash-out.)
5. Controindicazione all'uso Copaxone.

Potrebbero essere applicati altri criteri di esclusione definiti dal protocollo.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the mean number of T1 Gd-enhancing lesions per patient per scan measured over 5 monthly visits (Weeks 24, 28, 32, 36 and 40).

Numero medio di nuove lesioni captanti il Gd pesate in T1 per paziente per scansione da 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.

E.5.1.1

Timepoint(s) of evaluation of this end point

40 weeks

40 settimane

E.5.2

Secondary end point(s)

Mean Annualized Relapse Rate.
· Percentage of patients remaining relapse-free at
Week 40.
· Mean number of new T1 Gd-enhancing lesions per
patient and scan from 5 serial MRI scans performed on
Weeks 24, 28, 32, 36, and 40.
· Mean number of new or enlarging T2 lesions per patient and scan from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.
· Mean number of new, unenhancing T1 lesions (black holes) per patient and scan on MRI scans from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.
· Mean change in volume of T1 Gd-enhancing lesions per patient baseline vs. mean of 5 serial MRI scans performed on Weeks 24, 28, 32, 36, and 40.
· Mean change per patient in volume of T2 Gd-enhancing lesions baseline vs. last MRI scan performed between Weeks 24 and 40.
· Time to first relapse.
· Mean change in brain volume per patient baseline vs. last MRI performed between Weeks 24 and 40.

• Tasso annuale di recidive (ARR) medio alla Settimana 40.
• Percentuale di pazienti rimasti privi di recidiva alla Settimana 40.
• Numero medio di nuove lesioni captanti il Gd pesate in T1 per paziente e scansione da 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.
• Numero medio di nuove lesioni o di lesioni in crescita pesate in T2 per paziente e scansione da 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.
• Numero medio di nuove lesioni non captanti pesate in T1 (buchi neri) per paziente e scansione da 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.
• Variazione media in volume di lesioni captanti il Gd pesate in T1 per paziente al basale rispetto alle scansioni medie di 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.
• Variazione media per paziente nel volume di lesioni captanti il Gd pesate in T2 al basale rispetto all’ultima scansione RMI eseguita tra le settimane 24 e 40.
• Tempo alla prima recidiva.
• Variazione media nel volume cerebrale per paziente al basale rispetto all’ultima RMI eseguita tra le Settimane 24 e 40.

E.5.2.1

Timepoint(s) of evaluation of this end point

40 weeks

40 settimane

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tollerabilità

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

in cieco per colui che valuta (rater blinded)

Rater blinded

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

Bulgaria

Colombia

Czech Republic

Finland

Greece

Hungary

Italy

Mexico

Poland

Serbia

South Africa

Spain

Turkey

United Kingdom

United States

Croatia

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

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:

550

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

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

335

F.4.2.2

In the whole clinical trial

550

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

nessuno

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

2013-10-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-03-03

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