Clinical Trials Register

Summary
EudraCT Number:	2018-002783-88
Sponsor's Protocol Code Number:	331-201-00182
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-10-25
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

Spain - AEMPS

A.2

EudraCT number

2018-002783-88

A.3

Full title of the trial

A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer’s Type

Estudio de extensión con tratamiento activo, multicéntrico, de 12 semanas para evaluar la seguridad y la tolerabilidad del brexpiprazol en el tratamiento de sujetos con agitación asociada con la demencia de tipo Alzheimer

A.3.1

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

A 12-week, Multicenter, Active-treatment Extension Trial to check how safe, tolerable and effective Brexpiprazole is in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer’s Type

A.4.1

Sponsor's protocol code number

331-201-00182

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	Otsuka Pharmaceutical Development & Commercialization, Inc.
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	Otsuka Pharmaceutical Development & Commercialization, Inc.
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	Otsuka Pharmaceutical
B.5.2	Functional name of contact point	Jocelyn Ottinger
B.5.3	Address:
B.5.3.1	Street Address	2440 Research Boulevard
B.5.3.2	Town/ city	Rockville
B.5.3.3	Post code	20850
B.5.3.4	Country	United States
B.5.6	E-mail	jocelyn.ottinger@otsuka-us.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	REXULTI®
D.2.1.1.2	Name of the Marketing Authorisation holder	Otsuka Pharmaceutical Development & Commercialization, Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Brexpiprazole
D.3.2	Product code	OPC-34712
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	Brexpiprazole
D.3.9.1	CAS number	913611-97-9
D.3.9.2	Current sponsor code	OPC-34712
D.3.9.3	Other descriptive name	BREXPIPRAZOLE
D.3.9.4	EV Substance Code	SUB91646
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	0.5
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	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	Yes
D.2.1.1.1	Trade name	REXULTI®
D.2.1.1.2	Name of the Marketing Authorisation holder	Otsuka Pharmaceutical Development & Commercialization, Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Brexpiprazole
D.3.2	Product code	OPC-34712
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	Brexpiprazole
D.3.9.1	CAS number	913611-97-9
D.3.9.2	Current sponsor code	OPC-34712
D.3.9.3	Other descriptive name	BREXPIPRAZOLE
D.3.9.4	EV Substance Code	SUB91646
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	1
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	Yes
D.2.1.1.1	Trade name	REXULTI®
D.2.1.1.2	Name of the Marketing Authorisation holder	Otsuka Pharmaceutical Development & Commercialization, Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Brexpiprazole
D.3.2	Product code	OPC-34712
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	Brexpiprazole
D.3.9.1	CAS number	913611-97-9
D.3.9.2	Current sponsor code	OPC-34712
D.3.9.3	Other descriptive name	BREXPIPRAZOLE
D.3.9.4	EV Substance Code	SUB91646
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	2
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: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	REXULTI®
D.2.1.1.2	Name of the Marketing Authorisation holder	Otsuka Pharmaceutical Development & Commercialization, Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Brexpiprazole
D.3.2	Product code	OPC-34712
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	Brexpiprazole
D.3.9.1	CAS number	913611-97-9
D.3.9.2	Current sponsor code	OPC-34712
D.3.9.3	Other descriptive name	BREXPIPRAZOLE
D.3.9.4	EV Substance Code	SUB91646
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	3
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.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

Agitation Associated With Dementia of the Alzheimer's Type

Agitación asociada a la demencia de tipo Alzheimer (AAD)

E.1.1.1

Medical condition in easily understood language

Agitation in dementia due to Alzheimer's Disease

Agitación en demencia debido a la enfermedad de 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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10012271
E.1.2	Term	Dementia Alzheimer's type
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 long-term safety and tolerability of oral brexpiprazole as treatment in adult subjects with Agitation in Alzheimer’s dementia (AAD).

Evaluar la seguridad y tolerabilidad a largo plazo del brexpiprazol oral como tratamiento de sujetos adultos con AAD.

E.2.2

Secondary objectives of the trial

Exploratory:To assess the long-term efficacy of oral brexpiprazole as treatment in adult subjects with Agitation in Alzheimer’s dementia.

Exploratorios: Evaluar la eficacia a largo plazo del brexpiprazol oral como tratamiento de adultos con AAD.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.The investigator must assess the capacity of the subject to provide informed consent prior to enrollment. Once this determination is made by the investigator, the options for obtaining informed consent from or on behalf of the subject must be followed as provided in the protocol.
2.Subjects who completed 12 weeks of post-randomization treatment in Trial 331-14-213.
3.Institutionalized subjects with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject’s symptoms and has direct observation of the subject’s behavior. The identified caregiver can be a staff member of the institutionalized setting or another individual (eg, family member, family friend, hired professional caregiver) who meets the caregiver requirements.
Non-institutionalized subjects may not be living alone and must have an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject’s symptoms and has direct observation of the subject’s behavior.
4.Subjects who are able to satisfactorily comply with the protocol requirements.

1. Los investigadores deben valorar la capacidad del sujeto para proporcionar el consentimiento informado antes del reclutamiento. Una vez que el investigador ha hecho esta determinación, las opciones para obtener el consentimiento informado de o en nombre del sujeto deben ser seguidas como se indica en el protocolo.
2. Sujetos que completaron 12 semanas de tratamiento después de la aleatorización en el estudio 331-14-213.
3. Sujetos que viven en una institución con un cuidador identificado que tenga un contacto suficiente (mínimo de 2 horas al día durante 4 días a la semana) para describir los síntomas del sujeto y tenga observación directa de la conducta del sujeto. El cuidador identificado puede ser un miembro del personal de la institución u otro individuo (p.ej. familiar, amigo de la familia, cuidador profesional contratado) que cumpla los requisitos de cuidador.
4. Sujetos que son capaces de cumplir satisfactoriamente con los requerimientos del protocolo.

E.4

Principal exclusion criteria

1.Subjects who, in the opinion of the investigator, medical monitor, or sponsor, should not participate in the trial.
2.Subjects with a substantial protocol violation during the course of their participation in the double-blind Trial 331-14-213. Lesser violations such as occasional visits outside of the acceptable window or a missing blood draw will not exclude a subject from participation in Trial 331-201-00182; however, continual lack of compliance with the visit schedule, trial assessments, or treatment regimen in the prior double-blind trial would be considered a substantial violation that would result in exclusion from Trial 331-201-00182. The medical monitor should be contacted if the investigator is unsure of a subject’s eligibility.

1. Sujetos que, en opinión del investigador, monitor médico o promotor, no deban participar en el estudio clínico.
2. Sujetos que cometan un incumplimiento importante del protocolo durante su participación en el estudio doble ciego 331 14-213. Los incumplimientos menores, por ejemplo, visitas esporádicas fuera del margen de tiempo permitido o pérdida de una extracción de sangre, no excluirán al sujeto de la participación en el estudio 331-201-00182, si bien la falta continuada de cumplimiento con el calendario de visitas, con las evaluaciones del estudio o con la pauta de tratamiento en el estudio precedente doble ciego se considerará un incumplimiento importante del protocolo que sí daría lugar a la exclusión del estudio 331-201-00182. Si el investigador no está seguro de la idoneidad del sujeto, debe contactar con el monitor médico.

E.5 End points

E.5.1

Primary end point(s)

The primary outcome variable is the frequency and severity of adverse events (AEs; safety and tolerability of brexpiprazole).

La variable principal de valoración es la frecuencia y gravedad de los acontecimientos adversos (AA; seguridad y tolerabilidad del brexpiprazol).

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary safety analysis is the frequency and severity of AEs

El análisis principal de seguridad es la frecuencia y gravedad de los AA

E.5.2

Secondary end point(s)

Exploratory efficacy endpoints are as follows:
•Change from baseline CMAI total score at Week 6, Week 12, and last available visit
•Change from baseline Clinical Global Impression Severity of Illness (CGI-S) score, as related to agitation, at Week 6, Week 12, and last available visit

Los criterios exploratorios de valoración de la eficacia se definen a continuación:
• Cambio de la puntuación total CMAI inicial en la semana 6, semana 12 y última visita disponible
• Cambio de la puntuación CGI-S inicial, relacionado con la agitación, en la semana 6, semana 12 y última visita disponible

E.5.2.1

Timepoint(s) of evaluation of this end point

CMAI: Change from baseline CMAI total score at Week 6, Week 12, and last available visit
CGI-S: Change from baseline CGI-S score at Week 6, Week 12, and last available visit

CMAI: Cambio de la puntuación total CMAI inicial en la semana 6, semana 12 y última visita disponible
CGI-S: Cambio de la puntuación CGI-S inicial, relacionado con la agitación, en la semana 6, semana 12 y última visita disponible

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

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

Yes

E.8.1.7.1

Other trial design description

Para preservar el ciego en el ensayo 331-14-213, las dosis en el estudio 331-201-00182 serán ciegas

To preserve the blind in Trial 331-14-213, all doses in Trial 331-201-00182 will remain blinded.

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

Para preservar el ciego en el ensayo 331-14-213, las dosis en el estudio 331-201-00182 serán ciegas

To preserve the blind in Trial 331-14-213, all doses in Trial 331-201-00182 will remain blinded

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

Bulgaria

Hungary

Serbia

Spain

Ukraine

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

The end of trial date is defined as the last date of contact or the date of final contact attempt from the post-treatment follow-up eSource page for the last subject completing or withdrawing from the trial.

La fecha de fin del ensayo se define como la última fecha de contacto o la fecha del intento de contacto final en la página de seguimiento posterior al tratamiento para el ultimo sujeto completado y discontinuado del ensayo.

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

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)

Yes

F.1.3.1

Number of subjects for this age range:

205

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Due to the disease condition i.e. dementia due to Alzheimer's disease.

Debido a las características de la enfermedad i.e. demencia debido a la enfermedad de Alzheimer

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Patients with dementia fall under vulnerable group

Pacientes con demencia entran en la categoría de vulnerables

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

114

F.4.2.2

In the whole clinical trial

225

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will revert to normal standard of care.

Los pacientes volverán a la atención estandar normal

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-01-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-17

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

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Clinical trials