Clinical Trials Register

Summary
EudraCT Number:	2021-003816-20
Sponsor's Protocol Code Number:	MARYLU
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:	2021-10-12
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

2021-003816-20

A.3

Full title of the trial

IMPACT OF STRUCTURAL AND MYELIN ABNORMALITIES ON COGNITIVE IMPAIRMENTS IN RECENT-ONSET SCHIZOPHRENIA – before and after lurasidone treatment

IMPATTO DELLE ANOMALIE STRUTTURALI E MIELINICHE SUI DEFICIT COGNITIVI IN PAZIENTI CON SCHIZOFRENIA AD ESORDIO RECENTE - prima e dopo il trattamento con Lurasidone

A.3.1

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

Effect of lurasidone on cerebral structure in patients with recent-onset schizophrenia

Impatto della terapia antipsicotica con lurasidone sulla struttura cerebrale dei pazienti con schizofrenia ad esordio recente

A.3.2

Name or abbreviated title of the trial where available

MARYLU

A.4.1

Sponsor's protocol code number

MARYLU

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	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
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	Società Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. - Viale Amelia, 70 - Roma
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	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
B.5.2	Functional name of contact point	UOC Psichiatria
B.5.3	Address:
B.5.3.1	Street Address	via Francesco Sforza, 35
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	0255035982
B.5.5	Fax number	0255035952
B.5.6	E-mail	paolo.brambilla@policlinico.mi.it

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	LATUDA - 37 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER ALU/ALU - 28X1 COMPRESSE (DOSE UNITARIA)
D.2.1.1.2	Name of the Marketing Authorisation holder	TAKEDA PHARMA A/S
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	Latuda
D.3.2	Product code	[Lurasidone]
D.3.4	Pharmaceutical form	Film-coated tablet
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.3.8	INN - Proposed INN	Lurasidone
D.3.9.1	CAS number	367514-87-2
D.3.9.2	Current sponsor code	Lurasidone
D.3.9.3	Other descriptive name	Lurasidone Chlorhydrate
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	37
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	LATUDA - 18,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER ALU/ALU - 1X28 COMPRESSE (DOSE UNITARIA)
D.2.1.1.2	Name of the Marketing Authorisation holder	TAKEDA PHARMA A/S
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	Latuda
D.3.2	Product code	[Lurasidone]
D.3.4	Pharmaceutical form	Film-coated tablet
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.3.8	INN - Proposed INN	Lurasidone
D.3.9.1	CAS number	367514-87-2
D.3.9.2	Current sponsor code	Lurasidone
D.3.9.3	Other descriptive name	Lurasidone Chlorhydrate
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	18
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	LATUDA - 74 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER ALU/ALU - 28X1 COMPRESSE (DOSE UNITARIA)
D.2.1.1.2	Name of the Marketing Authorisation holder	TAKEDA PHARMA A/S
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	Latuda
D.3.2	Product code	[Lurasidone]
D.3.4	Pharmaceutical form	Film-coated tablet
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.3.8	INN - Proposed INN	Lurasidone
D.3.9.1	CAS number	367514-87-2
D.3.9.2	Current sponsor code	Lurasidone
D.3.9.3	Other descriptive name	Lurasidone Chlorhydrate
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	74
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

Schizophrenia

Schizofrenia

E.1.1.1

Medical condition in easily understood language

Schizophrenia

Schizofrenia

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

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	10039626
E.1.2	Term	Schizophrenia
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to assess whether the achievement of therapeutic control of the pathology by lurasidone corresponds to a change in brain structure in terms of connectivity.

L'obiettivo primario è quello di valutare se al raggiungimento del controllo terapeutico della patologia mediante lurasidone (3 mesi di trattamento) corrisponda una modifica della struttura cerebrale in termini di connettività.

E.2.2

Secondary objectives of the trial

- Assess whether the treatment with lurasidone induces a change in brain structure in terms of morphology.
- Evaluate the impact of lurasidone on clinical outcome, as described by number of relapses and symptomatology, global functioning and cognitive performances, in schizophrenic patients
- evaluate the safety profile of lurasidone
- Identify “normal” patterns of global functioning, myelination and cognitive performance by comparing schizophrenic patients before and after treatment with healthy controls.

• Valutare se il trattamento con lurasidone (3 mesi) induca una modifica della struttura cerebrale in termini morfologici
• Valutare l’effetto del lurasidone sull’outcome clinico (in termini di ricadute e sintomatologica clinica), sul funzionamento globale e sulle performance cognitive dei pazienti affetti da schizofrenia.
• Valutare il profilo di tollerabilità del farmaco.
• Indagare i pattern “normali” di funzionalità, mielinizzazione e di performance cognitive attraverso il confronto tra pazienti affetti da schizofrenia prima e dopo il trattamento con lurasidone e i controlli sani.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria for patients:
- Patients with recent-onset schizophrenia (< 5 years), diagnosed using a structured clinical interview (SCID- 5 CV) by medical doctors.
- Patients between 18 and 35 years of age, who have to start lurasidone therapy for clinical reasons (i.e. irrespective of study participation) or who have been on therapy for no more than two weeks.
- No other psychotropic treatments in the two weeks before entering the study
- Ability to provide informed consent
- If women with childbearing potential, a negative pregnancy test (Beta HCG urine or blood test) is required before administering the drug and an acceptable method of contraception (oral contraceptives, condom with or without spermicide, diaphragm, sponge or cervical cap with spermicide) for the duration of therapy.

Inclusion criteria for Healthy controls:
- Patients between 18 and 35 years old
- Ability to provide informed consent and to take part in study procedures

Criteri di inclusione per i pazienti:
- Affetti da schizofrenia ad esordio recente (< 5 anni), diagnosticati mediante il supporto di intervista clinica strutturata (SCID-5 CV) da parte di personale medico specializzato.
- Età compresa tra i 18 e i 35 anni compiuti, che devono iniziare una terapia con lurasidone per esigenze cliniche (e quindi indipendentemente dalla partecipazione allo studio) o già in terapia da non più di due settimane .
- Assenza di altri farmaci psicotropi per almeno due settimane precedenti all’inizio dello studio.
- Firma del consenso informato alla partecipazione allo studio
- se donne in età fertile, necessario test di gravidanza risultato negativo (ricerca Beta HCG urine o sangue) prima della somministrazione del farmaco e necessario utilizzo di un metodo contraccettivo accettabile (contraccettivi orali, profilattico con o senza spermicida, diaframma, spugna o cappuccio cervicale con spermicida) per tutta la durata della terapia.

Criteri di inclusione per i controlli sani:
- Età compresa tra 18 e 35 anni compiuti
- Capacità e disponibilità di fornire il consenso informato e di aderire alle procedure dello studio.

E.4

Principal exclusion criteria

Exclusion criteria for patients:
- Comorbidity with other psychiatric disorders (on the basis of SCID 5- CV) or neurologic disorders;
- Previous antipsychotic treatments. However, patients previously stabilised with other antipsychotic drugs will be admitted, provided that they have not been treated for more than one month and in the two weeks prior to enrolment.
- Medica history of intellectual disability
- Alchol or substances abuse in the last 6 months
- Presence of absolute or relative contraindications to the performance of MRI
- women with childbearing potential who have not carried out a negative pregnancy test before taking the drug and who are not using an acceptable method of contraception
- Pregnant women (if pregnancy occurs during the study, the patient will be excluded from continuing the study).

Exclusion criteria for Healthy controls:
- History of psychiatric disorders (based on SCID 5- CV) or neurologic disorders
- Intellectual disability
- Presence of current medical disorders
- Family history of hereditary neurological disease
- Presence of absolute or relative contraindications to the performance of MRI
- Alcohol or substance abuse
- Pregnant women (if pregnancy occurs during the study, the patient will be excluded from continuing the study).

Criteri di esclusione per pazienti:
- presenza di codiagnosi con altre patologie psichiatriche (sulla base della SCID-5 CV) o neurologiche;
- pregresse terapie antipsicotiche. Saranno comunque ammessi pazienti precedentemente stabilizzati con altri farmaci antipsicotici, purché assunti per un periodo di tempo non superiore a un mese e purchè non siano stati assunti nelle due settimane antecedenti all'arruolamento;
- presenza in anamnesi di disabilità intellettiva;
- abuso di alcool o sostanze nei 6 mesi precedenti;
- presenza di controindicazioni assolute o relative all’esecuzione di RM;
- donne in età fertile che non abbiano effettuato un test di gravidanza risultato negativo prima dell’assunzione del farmaco e che non utilizzino un metodo contraccettivo accettabile
- donne in stato di gravidanza (se la gravidanza sopraggiungesse durante lo studio la paziente verrà esclusa dalla prosecuzione dello studio).

Criteri di esclusione per controlli sani:
- Storia di patologie psichiatriche (sulla base della SCID-5) o neurologiche;
- Disabilità intellettiva
- Presenza di disturbi medici attuali;
- Storia familiare di disturbo neurologico ereditario
- Presenza di controindicazioni assolute o relative all’esecuzione di RM;
- Abuso di alcool e/o dipendenza
- donne in stato di gravidanza (se la gravidanza sopraggiungesse durante lo studio la paziente verrà esclusa dalla prosecuzione dello studio).

E.5 End points

E.5.1

Primary end point(s)

Significant modification of myelination of specific white tracts (Myelin Water Fraction- MWF) after antipsychotic treatment with lurasidone

Modificazione statisticamente significativa della mielinizzazione dei fasci di sostanza bianca (in termini di Myelin Water Fraction - MWF) dopo 3 mesi di trattamento con lurasidone rispetto al basale.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 months

3 mesi

E.5.2

Secondary end point(s)

- Significant brain structure modification (gray matter volumes, superficial cortical area, cortical
thickness) after antipsychotic treatment with lurasidone
- Evaluation of lurasidone efficacy on clinical outcome measured by variation of the score of psychopathological scales (PANSS and BPRS) and on cognitive performance in terms of variation of the score of neuropsychological scales (BAC-S) after three months of treatment
- Evaluation of lurasidone safety profile in terms of number of serious and non-serious AEs related to the treatment with lurasidone. Adverse events will be assessed on the basis of the patient's clinical observation, laboratory tests (e.g. biochemical, haematological, urine tests) or other clinical tests (e.g. ECG, radiological tests, vital signs).
- Assessment of grey matter volumes and white matter myelination in terms of Myelin Water Fraction (MWF), in healthy subjects and patients at baseline and after 3-month lurasidone treatment

• Modificazione statisticamente significativa della struttura (in termini di volumi di materia grigia, area corticale superficiale e spessore corticale)dopo 3 mesi di trattamento con lurasidone rispetto al basale.
• Valutazione dell’efficacia di lurasidone sull’outcome clinico, misurato tramite variazione dello score delle scale psicopatologiche (PANSS e BPRS), e sulle performance cognitive, misurate in termini di variazioni di punteggi delle scale neuropsicologiche (BAC-S), a 3 mesi rispetto al basale.
• Valutazione del profilo di tollerabilità sulla base del numero di EA seri e non seri giudicati dallo staff medico come correlati al farmaco oggetto di studio. Gli eventi avversi saranno valutati sulla base dell’osservazione clinica del paziente, di esami di laboratorio (ad es. biochimici, ematologici, test delle urine) o di altri esami clinici (ad es. ECG, esami radiologici, segni vitali)
¿ Stato dei volumi di sostanza grigia e di mielinizzazione, in termini di Myelin Water Fraction (MWF) nei pazienti affetti da schizofrenia prima e dopo il trattamento con lurasidone confrontati con i controlli sani

E.5.2.1

Timepoint(s) of evaluation of this end point

3 months

3 mesi

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

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

E.8.1.1

Randomised

E.8.1.2

Open

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

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

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

After study participation patients will go on with clinical assessments and treatment as normal clinical practice

Al termine della partecipazione allo studio i pazienti proseguiranno le visite di controllo ed il trattamento secondo la normale pratica clinica

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

2021-09-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-11-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-06-30

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