Clinical Trials Register

Summary
EudraCT Number:	2016-001128-78
Sponsor's Protocol Code Number:	ACP-103-033
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-12-27
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

2016-001128-78

A.3

Full title of the trial

A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects with Alzheimer’s Disease

Estudio abierto de extensión de 52 semanas con Pimavanserin para el tratamiento de la Agitación y la Agresión en pacientes con enfermedad de Alzheimer

A.3.1

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

The research study for patients with Alzheimer's disease to examine the safety and efficacy of Pimavanserin for the treatment of symptoms of agitation and aggression

Ensayo clínico para pacientes con enfermedad de Alzheimer para examinar la seguridad y eficacia del Pimavanserin en el tratamiento de los ´sintomas de agitación y agresión

A.4.1

Sponsor's protocol code number

ACP-103-033

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	ACADIA Pharmaceuticals 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	ACADIA Pharmaceuticals 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	ACADIA Pharmaceuticals Inc.
B.5.2	Functional name of contact point	AD Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	3611 Valley Centre Drive, Suite 300
B.5.3.2	Town/ city	San Diego
B.5.3.3	Post code	CA 92130
B.5.3.4	Country	United States
B.5.6	E-mail	AD_Trial_Info@ACADIA-Pharm.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	Nuplazid
D.2.1.1.2	Name of the Marketing Authorisation holder	ACADIA Pharmaceutical 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	Pimavanserin
D.3.2	Product code	ACP-103
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	Pimavanserin
D.3.9.1	CAS number	706782-28-7
D.3.9.2	Current sponsor code	ACP-103
D.3.9.3	Other descriptive name	PIMAVANSERIN TARTRATE
D.3.9.4	EV Substance Code	SUB128275
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	17
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	Pimavanserin
D.3.2	Product code	ACP-103
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	Pimavanserin
D.3.9.1	CAS number	706782-28-7
D.3.9.2	Current sponsor code	ACP-103
D.3.9.3	Other descriptive name	PIMAVANSERIN TARTRATE
D.3.9.4	EV Substance Code	SUB128275
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	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	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 and Aggression in Alzheimer's Disease

Agitación y agresion en la enfermedad de Alzheimer

E.1.1.1

Medical condition in easily understood language

Patients with Alzheimer's disease with symptoms that include agitation and aggressive behaviors

Pacientes con sintomas de la enfermedad de Alzheimer que incluyen agitación y conductas agresivas

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	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10001896
E.1.2	Term	Alzheimer's disease
E.1.2	System Organ Class	100000004852

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 evaluate the safety and tolerability of pimavanserin after 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression.

Evaluar la seguridad y tolerabilidad del Pimavanserin después de 52 semanas de tratamiento en los sujetos con probable EA que tienen síntomas de gaitación y agresión

E.2.2

Secondary objectives of the trial

To evaluate the persistence of the effects of pimavanserin treatment on:
• Agitation and aggression
• Caregiver burden
• The clinician’s global assessment of treatment benefit
• Other neuropsychiatric symptoms
• Cognition
• Functional status
• Sleep and daytime wakefulness

Evaluar la persistencia del efecto del tratamiento con pimavanserin
sobre los parámetros siguientes:
Agitación y agresividad.
Carga para el cuidador.
Evaluación global por el médico de los beneficios del tratamiento.
Otros síntomas neuropsiquiátricos.
Estado cognitivo.
Estado funcional.
Sueño y vigilia diurna.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Able to understand and provide signed informed consent, and must be able to sign and date a request for medical records and/or privacy form, if applicable, according to local regulations.
• from the subject, if the subject is deemed competent to provide informed consent
• from the subject’s legally authorized representative (LAR) with the subject’s assent, if the subject is deemed not competent to provide informed consent
2. Lives at home or in an assisted living facility
3. Has a designated study partner/caregiver (e.g., relative, housemate, close personal friend, or professional caregiver) who is in contact with the subject at least 3 times a week on 3 separate days. The study partner/caregiver should:
• be willing and able to accompany the subject to all clinic visits,
• be capable of routinely monitoring and reporting study drug use,
• be regarded by the Investigator as sufficiently informed to report accurately on the subject’s behavioral and functional status.
4. The subject’s study partner/caregiver provides written agreement that they understand the study, including the role of the study partner/caregiver and will participate in the study
5. Both subject and study partner/caregiver are fluent in and able to read the local language in which study assessments are administered at the clinical site
6. Both subject and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests
7. Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug
8. If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception (e.g., oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception) or abstinence during the study, and 1 month following completion of the study. Females of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Baseline.

1. Capacidad de comprender y otorgar el consentimiento informado firmado y de firmar y fechar una solicitud de historia clínica o un documento de privacidad, cuando proceda, conforme a la normativa local.
- del sujeto, si se considera que este es competente para otorgar el consentimiento informado;
- del representante legalmente autorizado del sujeto, con el asentimiento de este último, si se considera que el sujeto nes competente para otorgar el consentimiento informado.
2. El sujeto vive en casa o en un centro de residencia asistida.
3. El sujeto tiene un compañero/cuidador del estudio (por ejemplo,
un pariente, un compañero de casa, un amigo íntimo o un cuidaprofesional) que está en contacto con el sujeto al menos 3 veces por semana en tres días diferentes. El compañero/cuidador del estudio deberá:
- estar dispuesto a acompañar al sujeto a todas las visitas aclínica y ser capaz de hacerlo.
- ser capaz de supervisar sistemáticamente y notificar el uso
del fármaco del estudio.
- ser considerado por el investigador como suficiente informado para informar con exactitud sobre el estado decomportamiento y funcional del sujeto.
4. El compañero/cuidador del estudio acuerda por escrito que comprende el estudio, incluida la función del compañero/cuidador del estudio, y que participará en él.
5. Tanto el sujeto como el compañero/cuidador del estudio hablan deforma fluida y leen el idioma local en el que se realicen las evaluaciones del estudio en el centro clínico.
6. Tanto el sujeto como el compañero/cuidador del estudio están dispuestos a participar en todas las evaluaciones programadas y a completar todas las pruebas exigidas, y son capaces de hacerlo.
7. El sujeto debe completar la visita 12 del estudio ACP-103-032 mientras sigue recibiendo la dosis asignada de fármaco del estudio en régimen enmascarado.
8. Si el sujeto es una mujer, no debe tener capacidad reproductiva (definido como haber sido esterilizada quirúrgicamente o haber tenido la posmenopausia al menos 1 año antes) o debe comprometerse a usar un método anticonceptivo clínicamente aceptable (p. ej., anticonceptivos orales, dispositivo intrauterino [DIU; diafragma], anticonceptivos inyectables, transdérmicos o implantables) o a practicar la abstinencia durante el estudio y hastaun mes después de la finalización de su participación en el mismo. Las mujeres con capacidad reproductiva deben tener un resultado negativo en una prueba de embarazo de gonadotropina coriónica (hCG) en orina en la visita basal.

E.4

Principal exclusion criteria

1. Is participating in another clinical trial (other than Study ACP-103-032) of any investigational drug, device, or intervention
2. The Investigator determines that enrollment in the study would be detrimental to a subject’s well-being
3. The Investigator becomes aware of an impending and unexpected change in the subject’s living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver’s home to another) that s/he judges may cause a major disruption in the subject’s behaviour
4. Subject or study partner/caregiver has an uncorrected medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
5. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study
6. Subject was significantly non-compliant in Study ACP-103-032
7. Subject has had a QRS interval <120 msec and whose Fridericia’s corrected QT interval (QTcF) is >460 msec at baseline OR subject has had a QRS interval ≥120 msec and QTcF is >480 msec at Baseline
8. Has clinically significant laboratory abnormalities that in the judgment of the Investigator would jeopardize the safe participation of the subject in the study
9. Subject has become bedridden or has any significant medical condition that is unstable and that would either:
• place the subject at undue risk from study drug or undergoing study procedures;
or
• interfere with the interpretation of safety or efficacy evaluations performed during the course of the study

1. El sujeto está participando en otro ensayo clínico (distinto del
estudio ACP-103-032) de un fármaco, dispositivo o intervención
en investigación.
2. El investigador determina que la inclusión en el estudio sería
perjudicial para el sujeto.
3. El investigador tiene conocimiento de un cambio inminente e
imprevisto en la condiciones de vida del sujeto (p. ej., cambio de
cuidador, cambio de residencia, traslado desde casa a una
residencia, traslado desde el hogar de un familiar o cuidador al
hogar de otro) que considera que puede afectar de manera
importante a su conducta.
4. El sujeto o su compañero/cuidador del estudio padece un trastorno
médico no corregido (p. ej., alteración de la audición o de la visión)
que mermaría la capacidad para realizar las evaluaciones del estudio.
5. El investigador o el monitor médico consideran que el sujeto no es
apto para el estudio.
6. El sujeto incumplió de manera importante las condiciones del
estudio ACP-103-032.
7. El sujeto presentó un intervalo QRS < 120 ms y un intervalo QT
corregido conforme a la fórmula de Fridericia (QTcF) > 460 ms en el momento basal O un intervalo QRS ≥ 120 ms y un QTcF
> 480 ms en el momento basal.
8. El sujeto presenta una anomalía analítica de importancia clínica
que, a criterio del investigador, pondría en peligro la participación
segura del sujeto en el estudio.
9. El sujeto está encamado o padece algún trastorno médico
importante que sea inestable y que:
- pondría al sujeto en un riesgo excesivo si se le administrara
la medicación del estudio o se le sometiera a los
procedimientos del estudio; o
- interferiría en la interpretación de las evaluaciones de la
seguridad o de la eficacia realizadas en el transcurso del
estudio.

E.5 End points

E.5.1

Primary end point(s)

• Incidence and severity of AEs, serious AEs (SAEs), and withdrawals due to AEs
• Changes from Baseline in vital sign measurements, weight, clinical laboratory assessments, physical examinations, and electrocardiograms (ECGs)

- Incidencia e intensidad de los acontecimientos adversos (AA), los AA graves (AAG) y las retiradas debidas a AA.
- Cambios respecto al momento basal de las determinaciones de las constantes vitales, el peso, las valoraciones de laboratorio clínico, las exploraciones físicas y los electrocardiogramas (ECG).

E.5.1.1

Timepoint(s) of evaluation of this end point

• Adverse events during ACP-103-033 will be recorded through the follow-up safety assessment approximately 30 days after the last dose of open-label study drug.
• Physical and neurological examinations will be conducted at Baseline (Visit 1) and Weeks 12 and 52 (i.e., Visits 5 and 10 [EOS/ET]).
• Vital signs and weight will be performed at Baseline (Visit 1) and at all scheduled visits.
• A 12-lead ECG (single recording) will be performed at Baseline (Visit 1) and at Weeks 4, 12, 28, and 52 (i.e., Visits 3, 5, 7, and 10 [EOS/ET]).
• Samples for safety laboratory evaluations will be collected at Baseline (Visit 1) and Weeks 4, 12, 28, and 52 (i.e., Visits 3, 5, 7, and 10 [EOS/ET]).

E.5.2

Secondary end point(s)

• Change from Baseline in Cohen-Mansfield Agitation Inventory (CMAI) total score
• Change from Baseline in Zarit Burden Interview (ZBI) total score
• modified Alzheimer’s Disease Cooperative Study - Clinical Global Impression of Change (mADCS-CGIC) agitation score
• Change from Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) combined agitation and aggression domain scores
• Change from Baseline in NPI-C total score
• Change from Baseline in NPI-C individual domain scores
• Change from Baseline in Mini-Mental State Examination (MMSE) score
• Change from Baseline in Karolinska Sleepiness Scale (KSS) score
• Change from Baseline in CMAI factor scores
• Change from Baseline in Alzheimer’s Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) score

 Variación, con respecto al momento basal, de la puntuación
total del Índice de agitación de Cohen-Mansfield (CMAI).
 Variación, con respecto al momento basal, de la puntuación
total de la Escala de sobrecarga del cuidador de Zarit (ZBI).
 Puntuación de agitación en el Cuestionario de impresión
clínica global de cambio de la Escala del Alzheimer’s Disease
Cooperative Study modificada (mADCS-CGIC).
 Variación, con respecto al momento basal, del Inventario
neuropsiquiátrico-escala de valoración por el clínico (NPI-C).
 Variación, con respecto al momento basal, de la puntuación
total del NPI-C.
 Variación, con respecto al momento basal, de la puntuación de
cada dominio del NPI-C por separado.
 Variación, con respecto al momento basal, de la puntuación
del Miniexamen del estado mental (MMSE).
 Variación, con respecto al momento basal, de la puntuación de
la Escala de somnolencia de Karolinska (KSS).
 Variación, con respecto al momento basal, de la puntuación de
los factores del CMAI.
 Variación, con respecto al momento basal, de la puntuación en el Cuestionario de actividades de la vida diaria de la Escala del
Alzheimer’s Disease Cooperative Study (ADCS-ADL).

E.5.2.1

Timepoint(s) of evaluation of this end point

• The CMAI, ZBI and mADCS-CGIC will be performed at Baseline (Day 1) and at all scheduled clinic visits.
• The complete NPI-C (i.e., all domains) will be performed at Baseline, Weeks 12, 28, and 52 (i.e., Visits 1, 5, 7, and 10 [EOS/ET]). The agitation and aggression domains of the NPI-C alone will be performed at Weeks 2, 4, and 8 (i.e., Visits 2, 3, and 4).
• The MMSE will be administered at Baseline (Visit 1) and at Weeks 4, 8, 12, 20, 28, 36, 44, and 52 (i.e., Visits 3, 4, 5, 6, 7, 8, 9 and 10 [EOS/ET]).
• The ADCS-ADL and KSS will be administered at Baseline (Visit 1) and at Weeks 12, 28, and 52 (i.e., Visits 5, 7, and 10 [EOS/ET]).

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)

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

E.8.1.1

Randomised

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

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.8.3

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

Argentina

Chile

France

Germany

Spain

United Kingdom

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

UVUP

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

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:

108

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

324

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

There will be subjects that may be unable to give consent and for those people Sponsor has determined that a LAR is acceptable

Habrá pacientes que no podrán otorgar su consentimiento y para esos casos el promotor considera aceptable al representante legal

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

100

F.4.2.2

In the whole clinical trial

432

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)

None

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

2017-03-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-02-25

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IMP with orphan designation in the indication
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Clinical trials