Clinical Trials Register

Summary
EudraCT Number:	2015-003179-32
Sponsor's Protocol Code Number:	ToL54304
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-01
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

2015-003179-32

A.3

Full title of the trial

PREvention of Complications to Improve Outcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment.

PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment

A.3.1

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

PREvention of Complications to Improve Outcome in elderly patients with acute Stroke.

Prevenzione delle complicanze per migliorare l'esito dei pazienti anziani con ictus acuto

A.3.2

Name or abbreviated title of the trial where available

PRECIOUS

A.4.1

Sponsor's protocol code number

ToL54304

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN82217627

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	UNIVERSITY MEDICAL CENTER UTRECHT
B.1.3.4	Country	Netherlands
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	European Union’s Horizon 2020 Research and Innovat
B.4.2	Country	European Union
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	UNIVERSITY MEDICAL CENTER UTRECHT
B.5.2	Functional name of contact point	H.B. van der Worp, MD, PhD Departm
B.5.3	Address:
B.5.3.1	Street Address	Heidelberglaan 100
B.5.3.2	Town/ city	Utrecht
B.5.3.3	Post code	3584 CX
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31887571833
B.5.5	Fax number	+31302542100
B.5.6	E-mail	h.b.vanderworp@umcutrecht.nl

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	Paracetamolo
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi Italia S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	PARACETAMOLO
D.3.2	Product code	[N02BE01]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use Intravenous use Rectal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PARACETAMOLO
D.3.9.1	CAS number	103-90-2
D.3.9.2	Current sponsor code	AS3
D.3.9.3	Other descriptive name	PARACETAMOL
D.3.9.4	EV Substance Code	SUB09611MIG
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ceftriaxone
D.2.1.1.2	Name of the Marketing Authorisation holder	Sandoz GmbH
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	Ceftriaxone
D.3.2	Product code	[J01DD04]
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CEFTRIAXONE
D.3.9.1	CAS number	73384-59-5
D.3.9.2	Current sponsor code	AS3
D.3.9.3	Other descriptive name	CEFTRIAXONE
D.3.9.4	EV Substance Code	SUB07431MIG
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 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	Metoclopramide
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi S.p.A.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Metoclopramide
D.3.2	Product code	[A03FA01]
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	Oral use Intravenous use Rectal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METOCLOPRAMIDE
D.3.9.1	CAS number	364-62-5
D.3.9.2	Current sponsor code	AS3
D.3.9.3	Other descriptive name	metoclopramide
D.3.9.4	EV Substance Code	SUB08902MIG
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Stroke (ischaemic stroke or intracerebral hemorrhage)

Ictus (ischemico o emorragico)

E.1.1.1

Medical condition in easily understood language

Stroke (brain infarction or haemorrhage)

Ictus

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	22.1
E.1.2	Level	LLT
E.1.2	Classification code	10042244
E.1.2	Term	Stroke
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	22.1
E.1.2	Level	PT
E.1.2	Classification code	10061256
E.1.2	Term	Ischaemic stroke
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10022754
E.1.2	Term	Intracerebral hemorrhage
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 whether prevention of aspiration, infections and fever with metoclopramide, ceftriaxone, paracetamol, or any combination of these, in the first four days after stroke onset improves functional outcomes at 90 days in elderly patients with acute stroke.

Valutare se la somministrazione di metoclopramide, ceftriaxone, paracetamolo o qualsiasi combinazione di questi, nei primi giorni dopo un ictus nelle persone anziane, previene le aspirazioni, le infezioni e la febbre e migliorano l'esito a 90 giorni.

E.2.2

Secondary objectives of the trial

- To assess the effect of prevention of infections and fever in the first days after stroke onset with metoclopramide, ceftriaxone, paracetamol, or any combination of these, on the following outcomes at 90 days: death, death or dependency, quality of life, cognition, costs
- To detect specific populations classified by age, sex, stroke severity, body temperature, co-morbidities, and geographic region, in which the proposed treatments are particularly effective or not effective.
- To assess the effects of prophylactic treatment with ceftriaxone on antimicrobial resistance and the occurrence of infections with Clostridium difficile.

Valutare l'effetto della somministrazione di metoclopramide, ceftriaxone, paracetamolo o qualsiasi combinazione di questi, nei primi giorni dopo un ictus nelle persone anziane, sui seguenti aspetti a 90 giorni:
-morte, morte o dipendenza, qualità della vita, deterioramento cognitivo, costi
-selezionare specifiche popolazioni classificate per età, sesso, gravità dell'ictus, temperatura corporea, comorbidità e dislocazione geografica in cui i trattamenti sperimentati hanno o non hanno alcun effetto
- valutare l'effetto del trattamento profilattico con ceftriaxone sulla resistenza antibiotica e sull'incidenza di infezioni da Clostridium difficile.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. A clinical diagnosis of acute ischaemic stroke or intracerebral haemorrhage, confirmed with CT or MRI scan. A normal CT scan is considered compatible with ischaemic stroke;
2. A score on the National Institutes of Health Stroke Scale (NIHSS) = 6, indicating moderately severe to severe stroke;
3. Age 66 years or older;
4. The possibility to start treatment within 24 hours of symptom onset;
5. Written informed consent.

1.Diagnosi clinica di ictus acuto ischemico o da emorragia intracerebrale, confermata da TAC o da RMN.La TAC normale è considerata compatibilele con ictus ischemico
2.un punteggio al National Institutes of Health Stroke Scale (NIHSS) = 6 indica un ictus da moderatamente grave a grave.
3. 66 anni di età o oltre.
4.la possibilità di iniziare il trattamento entro le 24 ore dall'esordio dei sintomi,
5. consenso informato compilato

E.4

Principal exclusion criteria

1. Active infection requiring antibiotic treatment, as judged by the treating physician;
2. Clinical indication for one or more of the drugs tested in this patient;
3. Pre-stroke score on the mRS =4;
4. Death appearing imminent at the time of assessment.

In addition, patients will be excluded from participation in the trial treatment arms for any of the following reasons:
For the ceftriaxone arm:
1. Known hypersensitivity to beta-lactam antibiotics;
For the paracetamol arm:
1. Known hypersensitivity to paracetamol or any of the excipients;
2. Known severe hepatic insufficiency;
3. Chronic alcoholism
For the metoclopramide arm:
1. Hypersensitivity to the metoclopramide or to any of the excipients;
2. Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk;
3. Confirmed or suspected pheochromocytoma;
4. History of neuroleptic or metoclopramide-induced tardive dyskinesia;
5. Epilepsy;
6. Parkinson's disease;
7. Use of levodopa or dopaminergic agonists;
8. Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency.

1.Infezione che richiede un trattamento antibiotico sulla base del giudizio del medico curante
2.Indicazione clinica per uno o più dei trattamenti in esame, testati sul paziente,
3. Punteggio mRS =4 pre-ictus
4.Prognosi infausta a breve termine al momento della valutazione
Motivi di esclusione ulteriore:
Per il braccio ceftriaxone:
1.Ipersensibilità agli antibiotici beta-lattamici,
Per il braccio paracetamolo:
1.Ipersensibilità al paracetamolo o ai suoi eccipienti.
2.Grave insufficienza epatica nota,
3.Alcoolismo cronico.
Per il braccio metoclopramide:
1.Ipersensibilità al metoclopramide o ai suoi eccipienti.
2.Emorragia gastrointestinale, ostruzione meccanica o perforazione gastro-intestinale per cui la stimolazione della motilità gastrointestinale costituisce un rischio.
3. Feocromocitoma confermato o sospetto
4.Storia di discinesie tardive indotte da neurolettici o metoclopramide
5.Epilessia
6. Morbo di Parkinson
7.Uso di Levodopa o agonisti dopaminergici
8. Storia nota di metaemoglobinaemia da metoclopramide o dideficit di citocromo -b5 NADH

E.5 End points

E.5.1

Primary end point(s)

The primary outcome measure is the score on the modified Rankin Scale (mRS) at 90 days (± 14 days).

La misura primaria di esito è il punteggio alla scala Rankin modificata (mRS) a 90 giorni (± 14 giorni).

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary outcome will be evaluated on day 90 (± 14 days).

L'esito primario verrà valutato a 90 giorni (± 14 giorni).

E.5.2

Secondary end point(s)

Infections in the first 7 days (± 1 day; frequency, type, and C. difficile overgrowth syndrome). Infections will be categorised as diagnosed by the clinician, and as judged by an independent adjudication committee (masked to treatment allocation).; Death.; Unfavourable functional outcome, defined as mRS 3 to 6.; Disability assessed with the score on the Barthel Index (BI).; Cognition assessed with the Montreal Cognitive Assessment (MoCA).; Quality of life assessed with the EuroQol 5D-5L (EQ-5D-5L).; Antimicrobial use during the first 7 days (± 1 day), converted to units of defined daily doses according to the classification of the WHO Anatomical Therapeutic Chemical Classification System with Defined Daily Doses Index.; 3rd generation cephalosporin resistance in the first 7 days (± 1 day), detected as part of routine clinical practice.; - In a subgroup of patients: presence of Extended-Spectrum Beta-Lactamase (ESBL)-producing bacteria as detected by PCR in a rectal swab.; SAEs in the first 7 days.; Home time: duration of stay in the patient’s own home or a relative’s home over the first 90 days.; Patient location: hospital; rehabilitation service; chronic nursing facility; home.

Infezioni (frequenza e tipo, e sindrome da C. difficile). Le infezioni verranno categorizzate come diagnosticate dal curante e come verificate da un comitato indipendente (in cieco rispetto al trattamento).; Morte.; Esito funzionale sfavorevole definito con punteggio alla mRS da 3 a 6.; Disabilità valutata con punteggio al Barthel Index (BI).; Valutazione cognitiva con il Montreal Cognitive Assessment (MoCA).; Qualità della vita valutata con EuroQol 5D-5L (EQ-5D-5L); Utilizzo di antibiotici nei primi 7 giorni (± 1 day), convertiti in unità dose definita giornaliera come da classificazione dell'"Anatomical Therapeutic Chemical Classification System with Defined Daily Doses Index" dell'OMS.; Resistenza a cefalosporina di terza generazione nei primi 7 giorni ((± 1 giorno), identificata nel corso della praica clinica di routine.; In un sottogruppo di pazienti: presenza di batteri produttori di Beta-Lattamase a Spettro Esteso dimostrati con PCR su tampone rettale.; SAE nei primi 7 giorni.; Tempo di permanenza a casa: durata della permanenza a casa del paziente o di familiari nel corso dei primo 90 giorni dall'ictus.; Collocazione del paziente: ospedale, riabilitazione, residenza sanitaria, casa.

E.5.2.1

Timepoint(s) of evaluation of this end point

At 7 days (± 1 day) or at discharge, if earlier.; At 90 days (± 14 days).; At 90 days (± 14 days).; At 90 days (± 14 days).; At 90 days (± 14 days).; At 90 days (± 14 days).; At 7 days (± 1 day) or at discharge, if earlier.; At 7 days (± 1 day) or at discharge, if earlier.; At 7 days (± 1 day) or at discharge, if earlier.; At 7 days (± 1 day) or at discharge, if earlier.; At 90 days (± 14 days).; At 90 days (± 14 days).

A 7 giorni (± 1 giorno) o alla dimissione, se si verifica prima.; A 90 giorni (± 14 giorni).; A 90 giorni (± 14 giorni).; A 90 giorni (± 14 giorni).; A 90 giorni (± 14 giorni).; A 90 giorni (± 14 giorni).; A 7 giorni (± 1 giorno) o alla dimissione, se si verifica prima.; A 7 giorni (± 1 giorno) o alla dimissione, se si verifica prima.; A 7 giorni (± 1 giorno) o alla dimissione, se si verifica prima.; A 7 giorni (± 1 giorno) o alla dimissione, se si verifica prima.; A 90 giorni (± 14 giorni).; A 90 giorni (± 14 giorni).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Valutazione in cieco dell'esito

Blinded outcome assessment

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

Cure standard definite dai protocolli locali e dalle linee guida nazionali e internazionali

standard care as defined by local protocols and national and/or international guidelines

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

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

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

3800

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

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

The large majority of patients with moderately severe to severe stroke have a diminished decision-making capacity because of a reduced level of consciousness, aphasia, or another cognitive disorder.

La maggior parte dei pazienti con ictus da moderatamente grave a grave ha una ridotta capacità decisionale a causa di un deficit di coscienza afasia o altro disturbo cognitivo.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

460

F.4.2

For a multinational trial

F.4.2.1

In the EEA

3800

F.4.2.2

In the whole clinical trial

3800

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)

Standard care as defined by local protocols and national and/or international guidelines.

Cure standard così come definite da protocolli locali e/o dalle linee guida nazionali e internazionali

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

2016-07-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-29

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

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IMP with orphan designation in the indication
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