Clinical Trials Register

Summary
EudraCT Number:	2019-002678-29
Sponsor's Protocol Code Number:	ANAVEX2-73-PDD-EP-001
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:	2019-10-21
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2019-002678-29

A.3

Full title of the trial

Open Label Extension Study for Patients with Parkinson’s Disease with Dementia Previously Enrolled in ANAVEX2-73-PDD-001 Study for Continued Safety Assessment

Estudio abierto de extensión para pacientes con enfermedad de Parkinson y demencia incluidos previamente en el estudio ANAVEX2-73-PDD-001 para la
evaluación continua de la seguridad

A.3.1

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

Open Label Extension Study for Patients with Parkinson’s Disease with Dementia Previously Enrolled in ANAVEX2-73-PDD-001 Study for Continued Safety Assessment

Estudio abierto de extensión para pacientes con enfermedad de Parkinson y demencia incluidos previamente en el estudio ANAVEX2-73-PDD-001 para la
evaluación continua de la seguridad

A.4.1

Sponsor's protocol code number

ANAVEX2-73-PDD-EP-001

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	Anavex Life Sciences Corp.
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	Anavex Life Sciences Corp.
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	Leon Research S.L.
B.5.2	Functional name of contact point	Irene Mínguez Ardura
B.5.3	Address:
B.5.3.1	Street Address	C/ Julia Morros s/n Edif. Usos Comunes, Local 1 Parque Tecnológico León
B.5.3.2	Town/ city	Leon
B.5.3.3	Post code	24009
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34987 261 064
B.5.5	Fax number	+34987 216 243
B.5.6	E-mail	iminguez@leonresearch.es

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	ANAVEX2-73
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.3.8	INN - Proposed INN	ANAVEX2-73
D.3.9.2	Current sponsor code	ANAVEX2-73
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.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	ANAVEX2-73
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.3.8	INN - Proposed INN	ANAVEX2-73
D.3.9.2	Current sponsor code	ANAVEX2-73
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	20
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

Cognition in Parkinson’s Disease with Dementia

Deterioro cognitivo en la enfermedad de Parkinson con demencia

E.1.1.1

Medical condition in easily understood language

Cognition in Parkinson’s Disease with Dementia

Deterioro cognitivo en la enfermedad de Parkinson con demencia

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	10067889
E.1.2	Term	Dementia with Lewy bodies
E.1.2	System Organ Class	10029205 - Nervous system disorders

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	10061536
E.1.2	Term	Parkinson'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 continue assessing the safety and tolerability of ANAVEX2-73.

• Seguir evaluando la seguridad y la tolerabilidad de ANAVEX2-73.

E.2.2

Secondary objectives of the trial

• To continue evaluating the efficacy of ANAVEX2-73 in cognition.
• To continue assessing the efficacy of ANAVEX2-73 in reducing Parkinsonian motor symptoms.
• To continue assessing the efficacy of ANAVEX2-73 in improving sleep problems.

• Seguir evaluando la eficacia de ANAVEX2-73 en la cognición.• Seguir evaluando la eficacia de ANAVEX2-73 para reducir los síntomas motores parkinsonianos.
• Seguir evaluando la eficacia de ANAVEX2-73 para mejorar los problemas del sueño.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Previous completion of participation in the ANAVEX2-73-PDD-001 study.
2. Caregivers and subjects (or legal representative) must understand and have signed approved informed consent.
3. Caregivers and subjects (or legal representative) must be able to understand study requirements and be willing to follow instructions.
4. Stable regimen of anti-Parkinson’s disease medications (including levodopa, dopamine agonists, MAO-B inhibitors, or the COMT inhibitor entacapone), which has been stable for at least 4 weeks prior to Baseline.
5. Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon®, Aricept®, or Reminyl®) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to joining this study.
6. Subjects with history of depression on antidepressant medications will be allowed if depression is controlled and they have been on a stable daily dose of the antidepressant for ≥8 weeks before joining this study.
7. Contraception:
a. Women of childbearing potential must use an acceptable method of contraception starting 4 weeks prior to study drug administration and for a minimum of 4 weeks after study completion. Otherwise, women must be postmenopausal (at least one year absence of vaginal bleeding or spotting) as confirmed by FSH greater than or equal to 40 mIU/mL or 40 IU/L or be surgically sterile.
b. Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study and for 3 months after study drug discontinuation.
c. Note: For men and women, acceptable methods of contraception include use of a condom with spermicide or use of oral, implantable or injectable contraceptives, or IUD, or a diaphragm with spermicide or diaphragm with condom.

1. Finalización previa de la participación en el estudio ANAVEX2-73-PDD-001.
2. Tanto el cuidador (o un representante legal) como el paciente deben entender y firmar un documento de consentimiento informado.
3. El cuidador (o un representante legal) y el paciente deben entender los requisitos del estudio y estar dispuestos a seguir las instrucciones que reciban.
4. Pauta estable de medicación contra la enfermedad de Parkinson (como levodopa, agonistas de la dopamina, inhibidores de la MAO-B o el inhibidor de COMT entacapona) que se haya mantenido estable durante al menos las 4 semanas previas al momento basal.
5. Se permitirá el tratamiento con inhibidores de la colinesterasa (rivastigmina, donepezilo y galantamina) (Exelon®, Aricept® o Reminyl®), siempre que la dosis se haya mantenido estable durante al menos las 8 semanas previas a incorporarse al estudio.
6. Los pacientes con antecedentes de depresión o tratamiento con antidepresivos podrán participar si la depresión está controlada y si se han mantenido con una dosis diaria estable de antidepresivos durante al menos las 8 semanas previas a la incorporación al estudio.
7. Anticoncepción:
a. Las mujeres con capacidad de procrear deben utilizar un método anticonceptivo aceptable instaurado 4 semanas antes del inicio de la administración del fármaco del estudio y mantenido durante al menos 4 semanas después de la terminación del estudio. Las mujeres pueden también ser posmenopáusicas (ausencia de hemorragia vaginal u oligometrorragia desde hace al menos un año), un estado confirmado por un valor de FSH de al menos 40 mUI/ml o 40 UI/l, o estar esterilizadas quirúrgicamente.
b. Los varones con una pareja potencialmente fértil deben estar vasectomizados o estas dispuestos a utilizar un método anticonceptivo aceptable durante todo el estudio y en los 3 meses siguientes al final de la administración del fármaco del estudio.
c. Nota: Para varones y mujeres, son métodos anticonceptivos aceptables el preservativo con espermicida, los anticonceptivos orales, implantables o inyectables, el DIU, un diafragma con espermicida o un diafragma con preservativo.

E.4

Principal exclusion criteria

1. History of any significant neurologic or psychiatric disorder other than PD that can contribute to cognitive impairment.
2. Any other condition or clinically significant abnormal findings like severe co-morbidities e.g. history of stroke, poor kidney or liver function on the physical or neurological examination, medical and psychiatric history, at screening or at baseline that, in the opinion of the Investigator, would make the subject unsuitable for the study.
3. Potential symptomatic causes of cognitive impairment including but not limited to
a. abnormal thyroid function test at screening (TSH)
b. abnormal B12 level at screening
c. MRI findings (by history) pointing to a potential symptomatic cause of cognitive dysfunction, including significant vascular changes, or communicating hydrocephalus.
4. Treatment with memantine or amantadine. If appropriate the drugs can be discontinued for a minimum of 4 weeks prior to enrolment.
5. History of depression as measured by Beck Depression Inventory score >17 at screening.
6. Treatment with any other investigational drug or device within 4 weeks prior to screening.
7. Smoking > 1 pack of cigarettes per day (as assessed for the 4 weeks prior to screening).
8. Women who are pregnant or lactating.
9. Known allergy or sensitivity to ANAVEX2-73 or any of its components.
10. Suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or type 5, or any suicidal behavior, in the past 6 months. Type 4 indicates active suicidal ideation with some intent to act, without a specific plan. Type 5 indicates active suicidal ideation with a specific plan and intent.
11. Use of centrally acting anticholinergic drugs during the 4 weeks before enrolment.
a. Medications used for overactive bladder will be allowed provided that the regimen has been stable 4 weeks prior to enrolment.
12. Treatment with any dopamine receptor blocking medications with the exception of low dose quetiapine (≤50 mg/day). Pimavanserin (≤34 mg/day) will be allowed.
13. History of neurosurgical intervention (e.g., deep brain stimulation) for PD.
14. Unpredictable motor fluctuations that would interfere with administering cognitive assessments in the ON state.

1. Antecedentes de trastornos neurológicos o psiquiátricos de importancia distintos de la EP que puedan contribuir al deterioro cognitivo.
2. Cualquier otro trastorno o hallazgo anormal de importancia clínica, como enfermedades concomitantes graves, por ejemplo, antecedentes de ictus, función renal o hepática deficiente en la exploración física o neurológica y antecedentes médicos y psiquiátricos, en la selección o en el momento basal que, en opinión del investigador, motivaría que el paciente no fuese apto para el estudio.
3. Posibles causas sintomáticas de deterioro cognitivo, entre otras:
a. resultado anómalo en la prueba de la función tiroidea de selección (TSH).
b. concentración anormal de B12 en la selección.
c. hallazgos en la RM (según la historia) que indiquen una posible causa sintomática de la disfunción cognitiva, como alteraciones vasculares significativas o hidrocefalia comunicante.
4. Tratamiento con memantina o amantadina. Si procede, los fármacos podrán suspenderse durante un mínimo de 4 semanas antes del reclutamiento.
5. Antecedentes de depresión indicada por una puntuación superior a 17 en el Cuestionario de la depresión de Beck en la selección.
6. Tratamiento con otro fármaco o producto sanitario en investigación en los 4 días previos a la selección.
7. Tabaquismo > 1 paquete de cigarrillos al día (determinado durante las 4 semanas previas a la selección).
8. Mujeres embarazadas o lactantes.
9. Alergia o sensibilidad documentadas a ANAVEX2-73 o a cualquiera de sus componentes.
10. Ideación suicida de tipo 4 o 5 según la Escala de valoración de la intensidad del comportamiento suicida de Columbia (C-SSRS) o cualquier comportamiento suicida en los últimos seis meses. El tipo 4 indica ideación suicida activa con cierta intención de actuar, pero sin un plan concreto. El tipo 5 indica ideación suicida activa con un plan específico e intención.
11. Uso de anticolinérgicos de acción central en las 4 semanas previas al reclutamiento.
a. Se permiten los medicamentos utilizados para tratar la vejiga hiperactiva si la pauta se ha mantenido estable durante las 4 semanas previas al reclutamiento.
12. Tratamiento con cualquier medicamento bloqueante de los receptores de la dopamina, salvo quetiapina en dosis bajas (≤ 50 mg/día). Se permitirá pimavanserina (< 34 mg/día).
13. Antecedentes de intervenciones neuroquirúrgicas (por ejemplo, estimulación cerebral profunda) para el tratamiento de la EP.
14. Fluctuaciones motoras imprevisibles que puedan interferir en la realización de las evaluaciones cognitivas en el estado ON.

E.5 End points

E.5.1

Primary end point(s)

Safety Evaluation:
Criteria for assessment of safety and tolerability will include AEs, vital signs (blood pressure, heart rate, respiratory rate, pulse oximetry, and body temperature), hematology, clinical chemistry, urinalysis, and physical examination.
All enrolled patients will be included in the safety evaluation. All safety data will be listed by patient. Safety data including vital sign assessments, clinical laboratory evaluations, physical examinations, and AEs and their grading will be summarized by point of time of collection, when applicable. Descriptive statistics (including arithmetic mean, standard deviation, median, minimum and maximum) will be calculated for quantitative safety data as well as for the difference from baseline, when appropriate. In addition, a shift table describing out of normal range shifts will be provided for clinical laboratory results. A normal-abnormal shift table will also be presented for physical exam.
AEs will be coded using the latest version of MedDRA dictionary available at MDS and summarized by treatment group for the number of patients reporting the AE and the number of AEs reported. A by-patient AE data listing including verbatim term, coded term, treatment group, severity, and relationship to treatment will be provided.

Evaluación de la seguridad:
Los criterios de evaluación de la seguridad y la tolerabilidad serán los AA, constantes vitales (presión arterial, frecuencia cardíaca, frecuencia respiratoria, pulsioximetría y temperatura corporal), hematología, bioquímica clínica, análisis de orina y exploración física.
Se incluirá a todos los pacientes en la evaluación de la seguridad. Todos los datos de seguridad se presentarán por paciente. Los datos de seguridad, entre ellos, evaluaciones de constantes vitales, análisis clínicos, exploraciones físicas y AA, así como su graduación, se resumirán según el momento de obtención, según proceda. Se calcularán estadísticos descriptivos (media aritmética, desviación estándar, mediana, mínimo y máximo) para los datos de seguridad cuantitativos y, cuando proceda, para la diferencia con respecto al valor basal. Además, para los resultados de los análisis clínicos se dará una tabla de desviaciones que recogerá las desviaciones con respecto al intervalo normal. También se presentará una tabla con desviaciones normales y anormales para los resultados de las exploraciones físicas.
Los AA se codificarán con la última versión del diccionario MedDRA disponible en MDS y se resumirán por grupo de tratamiento en relación con el número de pacientes que notifiquen el AA y el número de AA notificados. Se aportará una lista de datos de AA por paciente con el término literal, el término codificado, el grupo de tratamiento, la intensidad y la relación con el tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

Change from baseline to End of Treatment

Cambio desde el momento basal al final del tratamiento

E.5.2

Secondary end point(s)

Efficacy Evaluation:
Collected at OLE baseline and at the final visit of the OLE study. If the interval between the ANAVEX2-73-PDD-001 study EOT visit and the start of OLE is less than 4 weeks, the ANAVEX2-73-PDD-001 EOT results will be used as the OLE baseline.
Efficacy measures: MDS – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts 1, 2, and 3; MoCA; sleep scales (Insomnia Severity Index [ISI], REM Sleep Behavior Disorder Screening Questionnaire [RBDSQ]); and Clinical Global Impression - Improvement scale (CGI- I).

Exploratory measures: change in microbiota between W0 and EOT

Evaluación de la eficacia:
Se obtendrá en el momento basal de la ERA y en la visita final del estudio ERA. Si el intervalo entre la visita de FDT del estudio ANAVEX2-73-PDD-001 y el inicio de la ERA es inferior a 4 semanas, se utilizarán los resultados del FDT de ANAVEX2-73-PDD-001 como valor basal de la ERA.
Mediciones de la eficacia: MDS: Escala unificada de valoración de la enfermedad de Parkinson (MDS-UPDRS) partes 1, 2 y 3; MoCA; escalas del sueño (Índice de intensidad del insomnio [ISI], Cuestionario de detección de trastornos del comportamiento durante el sueño REM [RBDSQ]); y Escala de Impresión Clínica Global - Mejoría (CGI- I).

Medidas exploratorias: variación de la microbiota entre la S0 y el FDT

E.5.2.1

Timepoint(s) of evaluation of this end point

Change from baseline to End of Treatment

Cambio desde el momento basal al final del tratamiento

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.8.2.4

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

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

Australia

Spain

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

LPLV

última visita del último paciente

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:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

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)

Compassionate use

Uso compasivo

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

2019-12-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-01

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

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Clinical trials