Clinical Trials Register

Summary
EudraCT Number:	2011-005217-37
Sponsor's Protocol Code Number:	I4O-MC-BACC
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:	2012-09-14
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

2011-005217-37

A.3

Full title of the trial

Assessment of Safety, Tolerability, and Pharmacodynamic Effects of
LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer's
Disease or Mild Alzheimer's Disease

Valutazione della sicurezza, della tollerabilità e degli effetti farmacodinamici di LY2886721 in pazienti affetti da deterioramento cognitivo lieve causato dal morbo di Alzheimer o dal morbo di Alzheimer lieve

A.3.1

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

Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's
Disease or Mild Alzheimer's Disease

Studio di LY2886721 relativo a deterioramento cognitivo lieve causato dal morbo di Alzheimer o dal morbo di Alzheimer lieve

A.4.1

Sponsor's protocol code number

I4O-MC-BACC

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01561430

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	ELI LILLY AND COMPANY
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	Eli Lilly and Company
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	Eli Lilly
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Clinical Trial Information
B.5.3.2	Town/ city	Clinical Trial Information
B.5.3.3	Post code	Clinical Trial
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	Clinical Trial Information
B.5.5	Fax number	Clinical Trial Information
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.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	LY2886721
D.3.2	Product code	LY2886721
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1262036-50-9
D.3.9.2	Current sponsor code	LY2886721
D.3.9.3	Other descriptive name	LY2886721
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
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	LY2886721
D.3.2	Product code	LY2886721
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1262036-50-9
D.3.9.2	Current sponsor code	LY2886721
D.3.9.3	Other descriptive name	LY2886721
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	35
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	Florbetapir (18F)
D.3.2	Product code	Florbetapir (18F)
D.3.4	Pharmaceutical form	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	Florbetapir (18F)
D.3.9.1	CAS number	956103-76-7
D.3.9.2	Current sponsor code	florbetapir F 18, AMYViD
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/ml megabecquerel(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	720 to 2090
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	Yes
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	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

Deterioramento cognitivo lieve causato dal morbo di Alzheimer o dal morbo di Alzheimer lieve

E.1.1.1

Medical condition in easily understood language

Alzheimer's Disease

Morbo di Alzheimer

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	15.0
E.1.2	Level	HLGT
E.1.2	Classification code	10029305
E.1.2	Term	Neurological disorders NEC
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10001896
E.1.2	Term	Alzheimer's disease
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the CSF PD effect of different LY2886721 doses in patients with MCI due to AD or mild AD compared to placebo, measured by change of CSF Aβ1-40 and Aβ1-42 concentrations from baseline to Week 12 and Week 26.

Valutare l’effetto farmacodinamico (FD) del fluido cerebrospinale (FCS) di dosi diverse di LY2886721 in pazienti affetti da deterioramento cognitivo lieve (MCI, mild cognitive impairment) causato dal morbo di Alzheimer (MA) o dal morbo di Alzheimer lieve rispetto al placebo, misurato mediante la variazione delle concentrazioni di Aβ1 40 e Aβ1 42 nel FCS dal basale alla Settimana 12 e alla Settimana 26.

E.2.2

Secondary objectives of the trial

To assess safety and tolerability of LY2886721 over 26 weeks.To compare cerebral vasogenic edema (CVE) and cerebral microhemorrhage (CMH) using fluid attenuation inversion recovery (FLAIR) and T2*w magnetic resonance imaging (MRI) associated with different doses of LY2886721 treatment or placebo.To assess the plasma PD effect of different LY2886721 doses compared to placebo, measured by change of plasma Aβ1-40 and Aβ1-42 concentrations from baseline to Week 12 and 26.To assess the effect of 2 doses of LY2886721 compared to placebo on the cognitive and behavioral symptoms of AD measured by Neuropsychological Test Battery (NTB), Alzheimer's Disease Assessment Scale – Cognitive subscale (ADAS-Cog), Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR), Mini Mental State Examination (MMSE), and Neuropsychiatric Inventory (NPI).

Valutare la sicurezza e la tollerabilità di LY2886721 nell’arco di 26 settimane.Mettere a confronto l’edema cerebrale vasogenico(CVE)e la microemorragia cerebrale(CMH)utilizzando il metodo dell’inversion recovery con attenuazione dei fluidi(FLAIR)e la RMI pesata in T2* associata a dosi diverse del trattamento con LY2886721 o placebo.Valutare l’effetto FD nel plasma di dosi diverse di LY2886721 rispetto al placebo, misurato mediante la variazione delle concentrazioni di Aβ1 40 e Aβ1 42 nel plasma dal basale alla Settimana 12 e 26.Valutare l’effetto di 2 dosi di LY2886721 rispetto al placebo sui sintomi cognitivi e comportamentali dell’MA misurato mediante batteria di test neuropsicologici(NTB)scala di valutazione del morbo di Alzheimer–subscala cognitiva(ADASCog),Test Selettivo di Memoria a Richiamo Immediato Libero e Guidato(FCSRT-IR)mini esame dello stato mentale(MMSE)e NPI.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Present with MCI due to AD or mild AD based on the disease diagnostic criteria.Are men or postmenopausal women, at least 55 years of age. Postmenopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years.Have a reliable caregiver/study informant who provides a separate written informed consent to participate and who is in frequent contact with the patient (defined as at least 10 hours per week). The caregiver/study informant must be able to communicate with site personnel and in the investigator's opinion must have adequate literacy to complete the protocol-specified questionnaires. If a caregiver/study informant cannot continue, 1 replacement is allowed.Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator.Have adequate premorbid literacy in the investigator's opinion to complete the required psychometric tests.Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

Presentano MCI causato da MA o MA lieve sulla base dei criteri diagnostici della malattia (Paragrafo 8.1.1).Sono uomini o donne in post-menopausa, di almeno 55 anni di età. Sono definite donne in post-menopausa quelle donne che hanno subito un’isterectomia e/o un’ovariectomia bilaterale; o quelle donne che risultano essere amenorreiche da almeno 2 anni.Hanno un assistente/informatore dello studio affidabile che fornisce un consenso informato scritto separato per la partecipazione e che è in frequente contatto con il/la paziente (indicato come almeno 10 ore settimanali). L’assistente/informatore dello studio deve essere in grado di comunicare con il personale del centro e, a giudizio dello sperimentatore, deve avere adeguata alfabetizzazione per completare i questionari indicati per il protocollo. Se un assistente/informatore dello studio è impossibilitato nel portare a termine l’incarico, è consentita 1 sostituzione.Avere, a giudizio dello sperimentatore, vista (non rientrare nel criterio di esclusione 12) e udito adeguati per i test neuropsicologici. Avere, a giudizio dello sperimentatore, competenze precedenti l’insorgenza della patologia tali da consentire il completamento dei test psicometrici richiesti.Avere fornito consenso informato scritto approvato da Lilly e dalla Commissione di revisione etica (ERB, Ethical Review Board) che disciplina il centro.

E.4

Principal exclusion criteria

Participant in another drug or device study•Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease or Parkinson's disease, progressive supranuclear palsy (PSNP) or other movement disorder •Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than two months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed•Have had a serious infectious disease affecting the brain in the past 5 years.•Have had a serious or repeat head injury.

Attualmente arruolati in, o hanno interrotto negli ultimi 30 giorni, una sperimentazione clinica relativa ad un prodotto sperimentale o ad un utilizzo non approvato di un farmaco o dispositivo (diverso dal prodotto sperimentale utilizzato nel presente studio) o contemporaneamente arruolati in qualsiasi altro tipo di ricerca medica giudicata non compatibile con questo studio da un punto di vista scientifico o medico.Anamnesi di grave malattia infettiva a carico del cervello, incluse meningite o encefalite, risalente agli ultimi 5 anni. Grave o ricorrente trauma cranico.

E.5 End points

E.5.1

Primary end point(s)

•Change from baseline to 12 weeks in cerebrospinal fluid (CSF) amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [Time Frame: Baseline, 12 weeks] •Change from baseline to 26 weeks in cerebrospinal fluid (CSF) amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [Time Frame: Baseline, 26 weeks]

-Variazione dal basale a 12 settimane nelle concentrazioni di beta amiloide(Aβ)1-40 e Aβ1-42 nel liquido cerebrospinale (CSF) [Frame Time: Basale, 12 settimane] -Variazione dal basale a 26 settimane nelle concentrazioni di beta amiloide(Aβ)1-40 e Aβ1-42 nel liquido cerebrospinale (CSF) [Frame Time: Basale, 26 settimane]

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

•Change from baseline in plasma amyloid beta (Aβ)1-40 and Aβ1-42 concentrations •Change from baseline to 26 weeks in Neuropsychological Test Battery (NTB) •Change from baseline to 26 weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) •Change from baseline to 26 weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) •Change from baseline to 26 weeks in Mini Mental State Examination (MMSE).

-Variazione dal basale nelle concentrazioni di beta amiloide(Aβ)1-40 e Aβ1-42 nel plasma. -Variazione dal basale a 26 settimane nella batteria di test neuropsicologici (NTB).-Variazione dal basale a 26 settimane nella scala di valutazione del morbo di Alzheimer– subscala cognitiva (ADAS Cog).-Variazione dal basale a 26 settimane nella somma delle caselle nella scala di valutazione clinica della demenza (CDR-SB).-Variazione dal basale a 26 settimane nel mini esame dello stato mentale (MMSE).

E.5.2.1

Timepoint(s) of evaluation of this end point

•Change from baseline in plasma amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [Time Frame: Baseline, 12 weeks, 26 weeks ] •Change from baseline to 26 weeks in NTB [Time Frame: Baseline, 26 weeks] •Change from baseline to 26 weeks in ADAS-Cog [Time Frame: Baseline, 26 weeks ] •Change from baseline to 26 weeks in the CDR-SB [ Time Frame: Baseline, 26 weeks ] •Change from baseline to 26 weeks in MMSE [Time Frame: Baseline, 26 weeks ]

-Variazione dal basale nelle concentrazioni di beta amiloide(Aβ)1-40 e Aβ1-42 nel plasma [Frame Time: Basale, 12 settimane].Variazione dal basale a 26 settimane nella NTB [Frame Time: Basale, 26 settimane]. Variazione dal basale a 26 settimane nella ADAS-Cog [Frame Time: Basale, 26 settimane]. Variazione dal basale a 26 settimane nel CDR-SB [Frame Time: Basale, 26 settimane]. Variazione dal basale a 26 settimane nel MMSE [Frame Time: Basale, 26 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

E.6.7

Pharmacodynamic

Yes

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)

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

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

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

Japan

United States

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

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)

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:

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

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

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

260

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)

As per protocol

Come da protocollo

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

2012-12-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-09-06

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2013-06-13

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