Clinical Trials Register

Summary
EudraCT Number:	2015-002142-31
Sponsor's Protocol Code Number:	547-SSE-301
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:	2018-03-02
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-002142-31

A.3

Full title of the trial

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAGE-547 INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS

A.3.1

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

CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A NEW
DRUG (SAGE-547) INJECTION IN THE TREATMENT OF SUBJECTS WITH
SUPER-REFRACTORY STATUS EPILEPTICUS

STUDIO CLINICO PER VALUTARE L'EFFICACIA E LA SICUREZZA DI UN NUOVO FARMACO (SAGE-547) INIETTABILE NEL TRATTAMENTO DI PAZIENTI CON STATO EPILETTICO SUPER-REFRATTARIO

A.3.2

Name or abbreviated title of the trial where available

STATUS TRIAL

A.4.1

Sponsor's protocol code number

547-SSE-301

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02477618

A.5.4

Other Identifiers

Name:

IND NUMBER

Number:

117901

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	SAGE THERAPEUTICS
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	SAGE THERAPEUTICS
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	SAGE THERAPEUTICS
B.5.2	Functional name of contact point	MEDICAL DIRECTOR
B.5.3	Address:
B.5.3.1	Street Address	215 First Street
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	MA 02142
B.5.3.4	Country	United States
B.5.4	Telephone number	001 617 2295234
B.5.5	Fax number	001 617 2998379
B.5.6	E-mail	clinicaltrials@sagerx.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.3.2	Product code	SAGE-547
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	516-54-1
D.3.9.2	Current sponsor code	SAGE-547
D.3.9.3	Other descriptive name	allopregnanolone
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	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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Super-Refractory Status Epilecticus (SRSE)

Stato Epilettico Super Refrattario (SRSE)

E.1.1.1

Medical condition in easily understood language

Status Epilecticus not responding to any of the conventional therapy regimen.

Stato epilettico non rispondente a nessuno dei regimi di terapia convenzionali

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10041962
E.1.2	Term	Status epilepticus
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the response to a 144-hour (6 day) continuous intravenous infusion of SAGE-547 compared to placebo administered to support the weaning of all third-line agents in adult and pediatric subjects with SRSE, and for the response to endure at least 24 hours after the end of the SAGE-547 or placebo infusion (primary response).

Determinare la risposta a un’infusione endovenosa continua di 144 ore (6 giorni) di SAGE-547 rispetto al placebo, somministrata per favorire lo svezzamento da tutti i farmaci di terza linea in pazienti adulti e pediatrici affetti da SRSE e indurre una durata della risposta di almeno 24 ore dopo la fine dell’infusione di SAGE-547 o placebo (risposta primaria).

E.2.2

Secondary objectives of the trial

To compare: 1.the time between meeting the primary response endpoint and the re-institution of any third-line agent; 2. secondary response from all third-line agents before the end of the first infusion of SAGE-547 or placebo; 3. the time between meeting the secondary response endpoint and the re-institution of any third-line agent; 4. the change in the Clinical Global Impression scale between SAGE-547 and placebo; To determine: 5. the number of days after the end of the first infusion of study drug that the subject does not have status epilepticus; 6.the number of days after the end of the first infusion of study drug that the subject does not have seizures; 7. the number of separate episodes of status epilepticus occurring; 8. the proportion of subjects with a new diagnosis of epilepsy.

Confrontare: 1. l’intervallo di tempo intercorso tra il raggiungimento dell’endpoint primario di risposta e la re-istituzione di una terapia con qualsivoglia farmaco di terza linea; 2. la risposta secondaria da tutti i farmaci di terza linea antecedentemente alla fine della prima infusione di SAGE-547 o placebo; 3. l’intervallo di tempo intercorso tra il raggiungimento dell’endpoint secondario di risposta, e la re-istituzione di una terapia con qualsivoglia farmaco di terza linea; 4. la variazione nella scala CGI per la valutazione dello stato clinico globale del paziente tra i due gruppi; Determinare: 5. il n. di giorni dopo la fine della prima infusione del farmaco in studio durante i quali il paziente non è in stato di male epilettico; 6. il n. di giorni dopo la fine della prima infusione del farmaco in studio durante i quali il paziente non manifesta crisi epilettiche; 7. il n. di episodi separati di stato di male epilettico che si verificano;8. La percentuale di pazienti con un

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

Protocollo V. amendment 2 specific for Italy-Thu Feb 04 00:00:00 CET 2016-Pharmacogenomic Sub-study-The objective of this research is to collect and store blood sample for possible DNA extraction and exploratory research into how genes or specific genetic variation may influence response (i.e. distribution, safety, tolerability, and efficacy) to SAGE-547.

Protocollo V. amendment 2 specific for Italy-Thu Feb 04 00:00:00 CET 2016-Sottostudio farmacogenomico-L'obiettivo di questa ricerca è quello di raccogliere e conservare campioni di sangue per un eventuale estrazione del DNA e una ricerca esplorativa sul come i geni o le variazioni genetiche specifiche possono influenzare la risposta (cioè la distribuzione, la sicurezza, la tollerabilità e l'efficacia) per SAGE-547.

E.3

Principal inclusion criteria

The following inclusion criteria must be met for individuals to be eligible for the trial.
1. Subjects two (2) years of age and older.
2. Subjects who have:
• Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to institution standard of care, and;
• Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED), according to institution standard of care, and;
• Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agent and in an EEG burst suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on a continuous intravenous infusion of at least one third-line agent or are on a continuous intravenous infusion of one or more third-line agent but not in an EEG burst suppression pattern.

1. Età pari o superiore a due (2) anni.
2. Pazienti:
• che non hanno ottenuto alcuna risposta alla somministrazione di almeno un farmaco di prima linea (per es. benzodiazepina o altro trattamento iniziale di emergenza con farmaci antiepilettici [Anti-Epileptic Drug, AED]), in base al trattamento standard adottato dalla struttura sanitaria, e;
• che non hanno ottenuto alcuna risposta ad almeno una terapia con un farmaco di seconda linea (per es. fenitoina, fosfenitoina, valproato, fenobarbital, levetiracetam o altri AED per il controllo urgente dei sintomi), in base al trattamento standard adottato dalla struttura sanitaria, e;
• ai quali non è stato somministrato in precedenza un farmaco di terza linea, ma che sono stati ricoverati in un’Unità di Terapia Intensiva al fine di essere trattati con almeno un farmaco di terza linea per almeno 24 ore; oppure sottoposti in precedenza, senza successo, a uno o più tentativi di svezzamento da farmaci di terza linea e attualmente in terapia con infusioni endovenose continue di uno o più farmaci di terza linea e con pattern di burst suppression sull’EEG; oppure sottoposti in precedenza, senza successo, a uno o più tentativi di svezzamento da farmaci di terza linea e attualmente non in terapia con un’infusione endovenosa continua di almeno un farmaco di terza linea o in terapia con un’infusione endovenosa continua di uno o più farmaci di terza linea ma senza pattern di burst suppression sull’EEG.

E.4

Principal exclusion criteria

1. Subjects who are pregnant.
2. Subjects with a known allergy to progesterone or allopregnanolone or any excipients in SAGE-547.
3. Subjects with SRSE due to anoxic/hypoxic encephalopathy.
4. Children (subjects aged less than 17 years) with an encephalopathy due to a rapidly progressing underlying neurological disorder.
5. Subjects who have any of the following:
a. a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned (that would not adequately remove Captisol®);
b. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
c. fulminant hepatic failure;
d. no reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the opinion of the investigator, of less than 30 days;
e. a do not resuscitate (DNR) order.
6. Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed within 24 hours, or who are being administered a third-line agent for other indications such as management of raised intra-cranial pressure that would preclude weaning according to this protocol.
7. Subjects with a living will that does not allow heroic measures.
8. Subjects who have been exposed to an investigational medication or device within 30 days; the exception to this is that participation in the Established Status Epilepticus Treatment Trial or ESETT within 30 days of screening for the 547-SSE-301 trial is allowed.
9. Subjects who have been enrolled in this trial or any other trial employing SAGE-547 previously (i.e., subjects may not withdraw or complete and then re-enroll).

1. Donne in stato di gravidanza.
2. Allergia nota al progesterone, all’allopregnanolone o a uno qualsiasi degli eccipienti di SAGE-547.
3. SRSE causato da encefalopatia anossica/ipossica.
4. Minori (pazienti di età inferiore a 17 anni) con encefalopatia causata da una preesistente patologia neurologica a rapida progressione.
5. Evidenza di una qualsiasi delle seguenti condizioni:
a. basso valore di velocità di filtrazione glomerulare (GFR), sufficiente a giustificare la dialisi per qualsivoglia motivo; tuttavia la terapia dialitica non è prevista o è prevista una terapia dialitica non continua (ciò non permetterebbe l’adeguata eliminazione di Captisol®);
b. grave shock cardiogeno o vasodilatatorio che richieda due o più vasopressori, non correlato all’uso del farmaco di terza linea;
c. insufficienza epatica fulminante;
d. nessuna ragionevole aspettativa di recupero (per esempio, un esito probabile è lo stato vegetativo persistente) o aspettativa di vita, a giudizio dello Sperimentatore, inferiore a 30 giorni;
e. ordine di non rianimare (Do Not Resuscitate, DNR).
6. Attuale somministrazione concomitante di più di tre farmaci di terza linea; oppure impossibilità di raggiungere il QW nelle 24 ore; oppure attuale somministrazione di un farmaco di terza linea per altre indicazioni, quale il trattamento dell’aumento della pressione intracranica, che potrebbe precludere lo svezzamento in base al presente protocollo.
7. Testamento biologico che vieta l’accanimento terapeutico.
8. Esposizione a un farmaco o dispositivo sperimentale nei 30 giorni precedenti la fase di screening; è tuttavia consentita la partecipazione alla sperimentazione clinica ESETT (Established Status Epilepticus Treatment Trial) nei 30 giorni precedenti la fase di screening per lo studio 547-SSE-301.
9. Arruolamento in questo studio o in qualsiasi altra sperimentazione clinica sull’uso di SAGE-547 in precedenza (per es. i pazienti non potranno ritirarsi da questo studio o completarlo e in seguito partecipare nuovamente all’arruolamento nello stesso).

E.5 End points

E.5.1

Primary end point(s)

Success or failure, with success defined as weaning the subject off all third-line agents before completion of the first blinded infusion of SAGE-547 or placebo, and not having to re-institute any third-line agent for seizure or burst suppression during the 24 hours after the end of the first infusion of SAGE-547 or placebo, and concurrent signs of physiologic brain activity as determined by EEG (primary response).

Successo o fallimento terapeutico, laddove per “successo terapeutico” si intende lo svezzamento del paziente da tutti i farmaci di terza linea antecedentemente al completamento della prima infusione di SAGE-547 o placebo somministrata in cieco e per i quali non sussiste la necessità di re-istituire una terapia con qualsivoglia farmaco di terza linea per il controllo delle crisi epilettiche o l’ottenimento di un’attività di burst suppression durante le 24 ore successive alla fine della prima infusione di SAGE-547 o placebo, con associata evidenza di segni concomitanti di attività fisiologica cerebrale valutata mediante EEG (risposta primaria).

E.5.1.1

Timepoint(s) of evaluation of this end point

24 hours after the end of study drug infusion

24 ore dopo la fine dell'infusione

E.5.2

Secondary end point(s)

1. The time between meeting the primary response endpoint and the re-institution of any third-line agent for seizure or burst suppression up to Visit 12;
2. Secondary response, defined as success of weaning the subject off all third-line agents before the end of the first SAGE-547 or placebo infusion;
3. The time between meeting the secondary response endpoint, defined in (2) above, and the re-institution of any third-line agent for seizure or burst suppression up to Visit 12;
4. The assessment of clinical status as measured by change in the CGI from Visit 1 (Screening) to Visit 12;
5. The number of days after the end of the first study drug infusion that the subject does not have status epilepticus, up to Visit 12;
6. The number of days after the end of the first study drug infusion that the subject does not have seizures (convulsive and non-convulsive) up to Visit 12;
7. The number of separate episodes of status epilepticus occurring up to Visit 12;
8. The proportion of subjects with a new diagnosis of epilepsy after Visit 11.
Safety endpoints:
1. Adverse events and medications;
2. Laboratory testing (hematology, serum chemistry, and urinalysis);
3. Vital signs (blood pressure, heart rate, temperature, and weight);
4. ECG parameters;
5. Mortality.

1. Intervallo di tempo intercorso tra il raggiungimento dell’endpoint primario di risposta e la re-istituzione della terapia con qualsivoglia farmaco di terza linea per il controllo delle crisi epilettiche o l’ottenimento di un’attività di burst suppression fino alla Visita 12;
2. Risposta secondaria, definita come lo svezzamento del paziente, eseguito con successo, da tutti i farmaci di terza linea antecedentemente alla fine della prima infusione di SAGE-547 o placebo;
3. Intervallo di tempo intercorso tra il raggiungimento dell’endpoint secondario di risposta, come definito al punto (2) di cui sopra, e la re-istituzione della terapia con qualsivoglia farmaco di terza linea per il controllo delle crisi epilettiche o l’ottenimento di un’attività di burst suppression fino alla Visita 12;
4. Valutazione dello stato clinico globale del paziente, espressa in base alla variazione nella scala CGI dalla Visita 1 (Screening) alla Visita 12;
5. Numero di giorni dopo la fine della prima infusione del farmaco in studio durante i quali il paziente non è in stato di male epilettico, fino alla Visita 12;
6. Numero di giorni dopo la fine della prima infusione del farmaco in studio durante i quali il paziente non manifesta crisi epilettiche (convulsive e non convulsive), fino alla Visita 12;
7. Numero di episodi separati di stato di male epilettico che si verificano fino alla Visita 12;
8. Percentuale di pazienti con una nuova diagnosi di epilessia dopo la Visita 11.
Endpoint di sicurezza:
1. Eventi avversi e terapie farmacologiche;
2. Analisi di laboratorio (ematologia, chimica sierica e esame delle urine);
3. Segni vitali (pressione arteriosa, frequenza cardiaca, temperatura corporea e peso);
4. Parametri ECG;
5. Mortalità.

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy: up to visit 12 or after visit 11 for end-point # 8
Safety: AEs and medications: V1-V12
ECG and vital signs: V1, V3-10
Lab tests: V1, V3, V4, V6, V8, V10, V11
Mortality: V12

Retreatment period:
AE and Medications: V3R-V12R
ECG and vital signs: V3R-V10R
Lab tests: V3R, V4R, V6R, V8R, V10R, V11R
Mortality: V12R

Efficacia: alla visita 12 o dopo la visita 11 per end-point n. 8
Sicurezza: Eventi Avversi e Farmaci: V1-V12
ECG e parametri vitali: V1, V3-V10
Tests di laboratorio: V1, V3, V4, V6, V8, V10, V11
Mortalità: V12

Periodo di ritrattamento:
Sicurezza: Eventi Avversi e Farmaci: V3R-V10R
ECG e parametri vitali: V3R, V10R
Tests di laboratorio: V3R, V4R, V6R, V8R, V10R, V11R
Mortalità: V12R

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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

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

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

Austria

Belgium

Canada

Denmark

Estonia

Finland

France

Germany

Hungary

Ireland

Israel

Italy

Netherlands

Serbia

Spain

Sweden

United Kingdom

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

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:

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:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-03-02.

Yes

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

subjects are unlikely to be able to consent themselves for the study due to coma or mental incapacity

è improbabile che i soggetti siano in grado di dare validamente il proprio consenso a causa dello stato di coma o incapacità mentale.

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

140

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)

according to standard of care

in accordo alla pratica clinica corrente

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

2016-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-07

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

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