Clinical Trials Register

Summary
EudraCT Number:	2016-004819-12
Sponsor's Protocol Code Number:	FullResponders
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2022-01-20
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-004819-12

A.3

Full title of the trial

Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial.

Sospensione del trattamento di prima linea in pazienti dopo un prolungato periodo di risposta completa al trattamento: studio clinico multicentrico randomizzato.

A.3.1

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

Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients

Sclerosi Multipla: effetti della sospensione del trattamento protratto con farmaci immunomodulanti di prima linea in pazienti "full responders"

A.3.2

Name or abbreviated title of the trial where available

Full Responders

A.4.1

Sponsor's protocol code number

FullResponders

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	OSPEDALE SAN RAFFAELE
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	AIFA - Italian Medicines Agency
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Phidealive S.r.l.
B.5.2	Functional name of contact point	Direzione Scientifica
B.5.3	Address:
B.5.3.1	Street Address	Viale Certosa 148
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20156
B.5.3.4	Country	Italy
B.5.4	Telephone number	0236580933
B.5.5	Fax number	0236580933
B.5.6	E-mail	m.salomone@phidealive.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	BETAFERON - 15 FLACONCINI 0.25 MG + 15 FLACONCINI 2 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER PHARMA AG
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.3.1	Product name	Interferone Beta-1B
D.3.2	Product code	[032166011]
D.3.4	Pharmaceutical form	Powder and solvent for 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	INTERFERONE BETA 1B
D.3.9.1	CAS number	145155-23-3
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	Interferon Beta-1B
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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	Yes
D.3.11.9	Recombinant medicinal product	Yes
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	AVONEX - 30 MCG (6 MILIONI UI) POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 4 FLACONI CON DISPOSITIVO BIOSET + 4 SIRINGHE PRERIEMPITE USO INTRAMUSCOLARE
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.3.1	Product name	Inteferone Beta-1A
D.3.2	Product code	[033283045]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INTERFERON BETA - 1A
D.3.9.1	CAS number	145258-61-3
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	Interferon Beta 1-A
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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	Yes
D.3.11.9	Recombinant medicinal product	Yes
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	COPAXONE - "40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA" 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA PHARMACEUTICALS 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.3.1	Product name	Glatiramer acetato
D.3.2	Product code	[035418060]
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 ACETATO
D.3.9.1	CAS number	147245-92-9
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	Glatiramer acetate
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	20 to 40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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: 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	REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML)12 PENNE PRERIEMPITE
D.2.1.1.2	Name of the Marketing Authorisation holder	MERCK SERONO EUROPE 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.3.1	Product name	Interferon Beta-1a
D.3.2	Product code	[034091165]
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	INTERFERON BETA - 1A
D.3.9.1	CAS number	145258-61-3
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	Interferon Beta-1a
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	11 to 44
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
D.3.11.9	Recombinant medicinal product	Yes
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 (RR-MS),

Sclerosi Multipla Recidivante Remittente

E.1.1.1

Medical condition in easily understood language

Relapsing-Remitting multiple sclerosis (RR-MS),

Sclerosi Multipla Recidivante Remittente

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.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the risk of reactivation of the disease after first-line DMT discontinuation, in MS patients with prolonged and full-responsive treatment.

Valutare se dopo una risposta completa e protratta al trattamento immunomodulante persista un rischio di riattivazione della malattia alla sospensione del trattamento

E.2.2

Secondary objectives of the trial

The secondary objective is to identify the predictive factors of disease reactivation after DMTs discontinuation:
- demographic and clinical variables (age, sex, disease and treatment duration, index of progression, EDSS, relapse annualized rate 1 and 2 years before starting DMT, interval between first and second attack, relapse rate in first 2 years of disease – where applicable-);
- laboratory findings (presence or absence of Oligoclonal Bands in the CSF, Vitamin D level at randomization);
- brain MRI variables (T2 hyperintense, T1 hypointense and Gd-enhancing lesion volumes at baseline, at disease onset, at treatment onset);
- multimodal evoked potential abnormalities at randomisation (motor, sensory, acoustic, visual).

Identificare le variabili demografiche, cliniche, strumentali (radiologiche e neurofisiologiche) e di laboratorio che predicono la riattivazione della malattia alla sospensione del trattamento dopo una prolungata risposta ottimale.Le variabili che verranno prese in considerazione sono: età, sesso, durata di malattia e di trattamento, disabilità espressa con la scala EDSS, frequenza annualizzata di ricadute nell'ultimo anno, negli ultimi 2 anni prima di iniziare il trattamento e nei primi 2 anni di malattia, intervallo temporale tra i primi due attacchi; carico lesionale in T2 alla RM encefalo all’esordio di malattia, all’inizio del trattamento e alla discontinuazione del trattamento immunomodulante, il numero di lesioni captanti il gadolinio all’esordio di malattia e all’inizio del trattamento; presenza di bande oligoclonali liquorali, livelli di vitamina D alla randomizzazione; anomalie ai potenziale evocati eseguiti alla randomizzazione.

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: 5.0
Date: 27/01/2021
Title: Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial
Objectives: The aim of the pharmacogenetics ancillary study is to collect measures of the genetic burden of patients treated with immunomodulatory drugs who will interrupt the treatment.

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial
Version 5.0 of 27-01-2021
Pharmacotranscriptomic Study
The pharmacotranscriptomic analysis will measure the complete transcriptome in the peripheral blood, in order to verify whether the response to the therapy of multiple sclerosis is associated with specific profiles of gene expression and whether patients show transcriptional markers that can predict the activity of disease following the interruption of therapy.

Farmacogenetica
Versione: 5.0
Data: 27/01/2021
Titolo: SOSPENSIONE DEL TRATTAMENTO DI PRIMA LINEA IN PAZIENTI DOPO UN PROLUNGATO PERIODO DI RISPOSTA COMPLETA AL TRATTAMENTO: STUDIO CLINICO MULTICENTRICO RANDOMIZZATO
Obiettivi: Studiare se la risposta alla terapia della sclerosi multipla sia associata a specifici profili di espressione genica e se i pazienti mostrino dei marcatori genetici o trascrizionali che possano predire l’attività di malattia in seguito all’interruzione della terapia.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: SOSPENSIONE DEL TRATTAMENTO DI PRIMA LINEA IN PAZIENTI DOPO UN PROLUNGATO PERIODO DI RISPOSTA COMPLETA AL TRATTAMENTO: STUDIO CLINICO MULTICENTRICO RANDOMIZZATO
Versione 5.0 del 27-01-2021
Studio Farmacotranscrittomica.
L’analisi di farmacotrascrittomica andrà a misurare il trascrittoma completo nel sangue periferico, al fine di verificare se la risposta alla terapia della sclerosi multipla sia associata a specifici profili di espressione genica e se i pazienti mostrino dei marcatori trascrizionali che possano predire l'attività di malattia in seguito all'interruzione della terapia.

E.3

Principal inclusion criteria

- patients with relapsing remitting multiple sclerosis
- males and females patients
- free from attacks and MRI active lesions in the last 4 years
- patients who require the discontinuation of DMT
- age between 18-55 years
- EDSS < 5.0
- women in childbearing age who use a contraceptive method
- patients negative to HIV blood examination
- patients negative to both HCV and HBV blood examination

- Pazienti con MSRR
- Pazienti trattati con TERAPIA IMMUNOMODULANTE: INFß 1a/1b, Galatiramer Acetato
- Stabilità radiologica e clinica di malattia ALMENO nei 4 anni precedenti l’inclusione
- Assenza di ricaduta di malattia alla V1 (di lesioni Gd+ e di nuove lesioni in T2 rispetto una RMN eseguita negli ultimi 4 MESI)
- Età tra i 18 e i 55 anni, Uomo/Donna
- EDSS <5.0
- Metodi contraccettivi adeguati per donne in età fertile
- Pazienti negativi ai test HIV, HCV, HBV

E.4

Principal exclusion criteria

- previous use of immunosuppressive treatments
- previous use of any experimental disease modifying treatments
- clinically relevant systemic diseases
- pregnancy

For IFNß-treated group:
- history of hypersensitivity to natural or recombinant interferon, human albumin, or any other component of the IFNß formulation
- history of depression and/or suicidal ideation
- active liver disease

For GA-treated group:
- history of hypersensitivity to GA or mannitol.

- Pazienti che non sono stati trattati con IMMUNOMODULANTI: INFß 1 a/1b, GA
- Precedenti trattamenti sperimentali
- Gravidanza
- Condizioni cliniche rilevanti

Per il Gruppo trattato con INFß 1a o INFß 1b
- storia di ipersensibilità all'interferone naturale o ricombinante, albumina umana o qualsiasi altro componente della formulazione di Ifnß
- storia di depressione o rischio suicidario
- epatopatia attiva

Per il gruppo trattato con Glatiramer acetato
- storia di ipersensibilità al CA o al mannitolo

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients free from disease activity at two years, defined as the combination of freeedom from attacks and < 2 cumulative brain MRI active lesions (combination of gadolinium enhancing lesions and new T2 lesions).

Proporzione di pazienti liberi da attività di malattia definita come combinazione di libertà da attacchi clinici e presenza di < 2 lesioni cumulative attive alla RMN encefalo durante l’osservazione. La lesione attiva è definita dalla presenza di lesioni captanti il gadolinio nelle sequenze in T1 e nuove lesioni nelle sequenze T2.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 years

2 anni

E.5.2

Secondary end point(s)

Proportion of relapse-free patients; Proportion of NEDA patients (absence of relapses, 12 week Confirmed Disability Progression, T1 Gd-enhancing lesion or new/enlarging T2 lesion); Time to disease reactivation (clinical or MRI); Time to first relapse; Proportion of patients free of MRI active lesions; Proportion of patients with Sustained Disability Progression; Comparison of frequency and degree of neurophysiological abnormalities during the study; Comparison of fatigue, depression, QoL, anxiety and depression scales, between the two groups

Proporzione di pazienti liberi da ricaduta; Percentuale di pazienti NEDA (assenza di recidive, progressione di disabilità confermata a 12 settimane, potenziamento della lesione T1-Gd o lesione nuova o aumento della lesione in T2); Tempo alla riattivazione della malattia (clinica o radiologica),; Tempo alla prima ricaduta,; Proporzione di pazienti liberi da lesioni attive; Proporzione di pazienti con progressione di disabilità sostenuta; Confronto della frequenza e del grado di anomalie neurofisiologiche durante lo studio; Confronto dell'affaticamento, del disturbo depressivo, della qualità di vita e dell’ansia tra i due gruppi di trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

2 years; 12 weeks; 2 years; 2 years; 2 years; 2 years; 2 years; 2 years

2 anni; 12 settimane; 2 anni; 2 anni; 2 anni; 2 anni; 2 anni; 2 anni

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

E.6.5

Efficacy

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)

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

E.8.1.3

Single blind

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Sospensione del trattamento

Discontinuation of treatment

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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:

230

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

300

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

300

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 treated following the neurologist decision

I pazienti verranno trattati secondo giudizio del medico neurologo

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

2018-01-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-13

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
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