Clinical Trials Register

Summary
EudraCT Number:	2020-005246-42
Sponsor's Protocol Code Number:	0796-19
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:	2021-10-19
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

Spain - AEMPS

A.2

EudraCT number

2020-005246-42

A.3

Full title of the trial

A Multicenter, Three- arm, Double- blind, Double dummy, Parallel-group, placebo controlled Study for efficacy and safety evaluation of prolonged release formulation of Betahistine PR 48 mg once daily in comparison with conventional release formulation of Betahistine IR 24 mg, twice daily in treatment of adult patients with Menière's disease.

Estudio multicéntrico, de tres brazos, doble ciego, doblemente enmascarado, de grupos paralelos, controlado con placebo para la evaluación de la eficacia y la seguridad de la formulación de liberación prolongada de betahistina PR 48 mg una vez al día en comparación con la formulación de liberación convencional de betahistina IR 24 mg, dos veces al día en el tratamiento de pacientes adultos con enfermedad de Meniere.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

BERTIGO

A.4.1

Sponsor's protocol code number

0796-19

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	INTAS PHARMACEUTICALS LIMITED
B.1.3.4	Country	India
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	INTAS PHARMACEUTICALS LIMITED
B.4.2	Country	India
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Alpha Bioresearch S.L.
B.5.2	Functional name of contact point	Clinical Project Leader
B.5.3	Address:
B.5.3.1	Street Address	C/ López de Hoyos 155, 3 6-7
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28002
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34917452520
B.5.5	Fax number	+34917450653
B.5.6	E-mail	regulatory@alphabioresearch.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Betahistina PR 48 mg
D.3.2	Product code	Betahistina PR 48 mg
D.3.4	Pharmaceutical form	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	Betahistine
D.3.9.1	CAS number	5579-84-0
D.3.9.3	Other descriptive name	BETAHISTINE DIHYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB25919
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	48
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	Comparator
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	Betahistina 24mg IR
D.2.1.1.2	Name of the Marketing Authorisation holder	Betaserc 24 mg
D.2.1.2	Country which granted the Marketing Authorisation	France
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	Betahistina
D.3.4	Pharmaceutical form	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	Betahistine
D.3.9.1	CAS number	5579-84-0
D.3.9.2	Current sponsor code	Betarsec
D.3.9.3	Other descriptive name	BETAHISTINE DIHYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB25919
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	23
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Menière´s disease

Enfermedad de Meniere

E.1.1.1

Medical condition in easily understood language

Menière´s disease

Enfermedad de Meniere

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

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	10047340
E.1.2	Term	Vertigo
E.1.2	System Organ Class	10013993 - Ear and labyrinth disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10022398
E.1.2	Term	Inner ear signs and symptoms
E.1.2	System Organ Class	10013993 - Ear and labyrinth 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 prove non-inferiority in terms of efficacy for the test product (betahistine PR 48 mg once daily) with that of reference product (Betaserc IR 24 mg twice daily) for treatment of patients with Meniere’s disease (symptoms of which may include nausea and vomiting, tinnitus and hearing loss)

Demostrar la no inferioridad en términos de eficacia del producto de prueba (betahistina PR 48 mg una vez al día) con la del producto de referencia (Betaserc IR 24 mg dos veces al día) para el tratamiento de pacientes con la enfermedad de Meniere (cuyos síntomas pueden incluir náuseas y vómitos, tinnitus y pérdida de audición).

E.2.2

Secondary objectives of the trial

To confirm betahistine efficacy in vertigo and its associated symptoms of Meniere's disease and monitor safety of the participants, who are exposed to the Investigational Medicinal Products.

Confirmar la eficacia de la betahistina en el vértigo y sus síntomas asociados de la enfermedad de Meniere y controlar la seguridad de los participantes, expuestos al medicamento en investigación.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or non-pregnant female patients ≥18 years of age.
2. Patient has a diagnosis of unilateral definite Meniere's disease by 1995 American Academy of Otolaryngology — Head and Neck Surgery (AAOHNS) criteria and reports history of frequent attacks of active vertigo on betahistine (soon after the start of an acute attack of vertigo) prior to the study lead-in/wash-out period.
3. Patient has experienced active vertigo of significant severity during the month prior to inclusion in the trial. Significant severity is defined as a naïve patient with a first episode classified as severe with a minimum score of 7 points according to the GISFaV self-rating scale:
-Intensity (V): 2 points = severe
-Duration (D): 3 points = some hours
-Frecuency of the crisis (F): 2 points = weekly or a pretreated patient with Betaserc IR 24 mg with severe episodes as defined before despite treatment (non-responders).
4. Patient has documented asymmetric sensorineural hearing loss.
5. Patients currently on a low salt diet at the time of screening agree to continue this low-salt diet throughout the study.
6. Patients who withdrawal of interfering concomitant therapies at least 7 days before the start of the study treatment.
7. Women with child-bearing potential should have a negative serum pregnancy test at screening visit at the start of the treatment. Such females and their partners should be ready to adopt required measures to avoid conception throughout the study participation.
8. Informed consent as obtained in Section 11.3 of the protocol.

1. Pacientes varones o mujeres no embarazadas ≥18 años de edad.
2. El paciente tiene un diagnóstico de enfermedad de Meniere unilateral definida según los criterios de la Academia Americana de Otorrinolaringología Cirugía de Cabeza y Cuello (AAOHNS) de 1995 e informa de antecedentes de ataques frecuentes de vértigo activo con betahistina (poco después del inicio de un ataque agudo de vértigo) antes del período de entrada/salida del estudio.
3. El paciente ha experimentado vértigo activo de gravedad significativa durante el mes anterior a la inclusión en el ensayo. La gravedad significativa se define como un paciente ingenuo con un primer episodio clasificado como grave con una puntuación mínima de 7 puntos según la escala de autocalificación del GISFaV:
-Intensidad (V): 2 puntos = grave
-Duración (D): 3 puntos = algunas horas
-Frecuencia de la crisis (F): 2 puntos = semanal o un paciente pretratado con Betaserc IR 24 mg con episodios graves como los definidos anteriormente a pesar del tratamiento (no respondedores).
4. El paciente tiene una pérdida auditiva neurosensorial asimétrica documentada.
5. Los pacientes que actualmente siguen una dieta baja en sal en el momento de la selección aceptan continuar con esta dieta baja en sal durante todo el estudio.
6. Pacientes que retiran las terapias concomitantes que interfieren al menos 7 días antes del inicio del tratamiento del estudio.
7. Las mujeres con potencial reproductivo deben tener una prueba de embarazo sérica negativa en la visita de cribado al inicio del tratamiento. Estas mujeres y sus parejas deben estar dispuestas a adoptar las medidas necesarias para evitar la concepción durante toda la participación en el estudio.
8. Consentimiento informado, tal y como se indica en la sección 11.3 del protocolo.

E.4

Principal exclusion criteria

1. Patient is pregnant or lactating.
2. Patient has a history of immunodeficiency disease.
3. Patient has a history of previous endolymphatic sac surgery.
4. Patient has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
5. History of tympanostomy tubes with evidence of perforation or lack of closure.
6. Patient has experienced an adverse reaction to IT injection of steroids.
7. Patient has used an investigational drug or device in 3 months prior to screening.
8. Patients with hypersensitivity to the active substance or to any of the excipients of the study drug.
9. Patients with pheochromocytoma.
10. Patient with middle or inner ear infection.
11. Patient with history or presence of significant alcoholism or drug abuse in the past one year.
12. Patients with psychiatric or significant neurological disorders, spinal cord damage, use of any other agents for Meniere's disease.
13. Patients with ear surgery for vestibular disorders.
14. Patients with peptic ulcer (including a history of this disorder).
15. Patients with asthmatic bronchitis, bronchial asthma, urticaria, exanthema or allergic rhinitis.
16. Patients with pronounced hypotension.
17. Patients receiving any other agents for peripheral vestibular vertigo such as diuretics, trans tympanic gentamycin, cinnarizine, competitive antagonist of histamine, blocking H1- histamine receptors.
- Patients:
• on current treatment with nti-vertigo drugs
• on current treatment withdrugs that act on cerebral circulation, antihistamines, calcium antagonists, antiagregant, thiazide diuretics, corticosteroids and benzodiazepines, • with any major medical or surgical condition likely to interfere with the absorption, distribution, metabolism or excretion of the drug used in the study
• with a terminal disease..
18. Patients with vestibular disorders other than Meniere’s disease such as benign paroxysmal positional vertigo perilymph fistula, vestibular neuronitis, viral labyrinthitis, benign paroxysmal vertigo of childhood, otosclerosis, giddiness of ischemic or neck origin together with a sensorineural hearing loss, cholesteatoma and fistula formation, disequilibrium after head injury, drug toxicity, vestibular neuroma, multiple sclerosis, cardiovascular disturbances, craniocervical dysplasia, syphilis and Cogan's syndrome.

1.Paciente embarazada o en periodo de lactancia.
2. El paciente tiene antecedentes de enfermedad de inmunodeficiencia.
3. El paciente tiene antecedentes de cirugía previa del saco endolinfático.
4. El paciente tiene antecedentes de uso previo de gentamicina intratimpánica (IT) en el oído afectado.
5. Antecedentes de tubos de timpanostomía con evidencia de perforación o falta de cierre.
6. El paciente ha experimentado una reacción adversa a la inyección IT de esteroides.
7. El paciente ha utilizado un fármaco o dispositivo en investigación en los 3 meses anteriores al cribado.
8. Pacientes con hipersensibilidad al principio activo o a cualquiera de los excipientes del fármaco del estudio.
9. Pacientes con feocromocitoma.
10. Pacientes con infección del oído medio o interno.
11. Paciente con historia o presencia de alcoholismo significativo o abuso de drogas en el último año.
12. Pacientes con trastornos psiquiátricos o neurológicos significativos, daños en la médula espinal, uso de cualquier otro agente para la enfermedad de Meniere.
13. Pacientes con cirugía de oído por trastornos vestibulares.
14. Pacientes con úlcera péptica (incluidos los antecedentes de este trastorno).
15. Pacientes con bronquitis asmática, asma bronquial, urticaria, exantema o rinitis alérgica.
16. Pacientes con hipotensión pronunciada.
17. Pacientes que reciban cualquier otro agente para el vértigo vestibular periférico, como diuréticos, gentamicina transtimpánica, cinarizina, antagonista competitivo de la histamina, que bloquee los receptores de histamina H1.
-Pacientes:
- en tratamiento actual con fármacos contra el vértigo
- en tratamiento actual con fármacos que actúan sobre la circulación cerebral, antihistamínicos, antagonistas del calcio, antiagregantes, diurétic tiazídicos, corticosteroides y benzodiacepinas,
- con cualquier condición médica o quirúrgica importante que pueda interferir en la absorción, distribución, metabolismo o excreción del fármaco utilizado en el estudio
- con una enfermedad terminal.
18. Pacientes con trastornos vestibulares distintos de la enfermedad de Meniere, como vértigo posicional paroxístico benigno, fístula perilinfática, neuronitis vestibular, laberintitis vírica, vértigo paroxístico benigno de la infancia, otoesclerosis, vértigo de origen isquémico o cervical junto con una hipoacusia neurosensorial, colesteatoma y formación de fístulas, desequilibrio tras un traumatismo craneal, toxicidad por fármacos, neuroma vestibular, esclerosis múltiple, alteraciones cardiovasculares, displasia cráneo-cervical, sífilis y síndrome de Cogan.

E.5 End points

E.5.1

Primary end point(s)

- Percentage of significant responders defined by 1-point change in any two of intensity, duration and frequency of vertigo attacks score based on GISFaV scale against baseline score.
- GISFaV self-rating scale [12] involving each item separately for determination of the disturbance stage of vertigo using values of intensity (V), duration (D) and associated symptoms (N), frequency of crisis (F), quality of life (Q) scored respectively by;
- A four-point scale (V: 0 =absent, 1= mild, 2= severe, 3= disabling),
- A five-point scale (D: 0= none, 1=<1 min, 2=<15 min, 3= some hours, 4=≥1 day) and
- A three-point scale (N: 0= absent, 1= nausea, 2= vomiting);
- Frequency of the crisis (F: 0=absent or sporadic, 1=monthly, 2=weekly, 3=daily, 4=multi-day)
- Quality of life (Q: 0=normal, 1=partial inactivity, 2= total inactivity)

- Porcentaje de respondedores significativos definidos por el cambio de 1 punto en dos de las puntuaciones de intensidad, duración y frecuencia de las crisis de vértigo basadas en la escala GISFaV frente a la puntuación inicial.
- Escala de autocalificación GISFaV [12] que incluye cada ítem por separado para la determinación del estadio de perturbación del vértigo mediante los valores de intensidad (V), duración (D) y síntomas asociados (N), frecuencia de las crisis (F), calidad de vida (Q) puntuados respectivamente por;
- Una escala de cuatro puntos (V: 0 = ausente, 1= leve, 2= grave, 3= incapacitante),
- Una escala de cinco puntos (D: 0= ninguna, 1=<1 min, 2=<15 min, 3= algunas horas, 4=≥1 día) y
- Una escala de tres puntos (N: 0= ausente, 1= náuseas, 2= vómitos);
- Frecuencia de la crisis (F: 0=ausente o esporádica, 1=mensual, 2=semanal, 3=diaria, 4=múltiple)
- Calidad de vida (Q: 0=normal, 1=inactividad parcial, 2=inactividad total)

E.5.1.1

Timepoint(s) of evaluation of this end point

End of study

Al final del estudio

E.5.2

Secondary end point(s)

-Number of asymptomatic days (no vertigo attacks) during treatment period.
-Patient rates with all the GISFaV items equal to 0 at 3 months.
-Change in number of monthly vertigo attacks during treatment period.
-The Dizziness Handicap Inventory (DHI) rating scale [13] for the identification of the difficulties that patients encounter during the vertiginous disease.
-Hearing will be scored as: 'good', 'slightly impaired', 'moderately impaired' or 'seriously impaired'. In addition, the patient will be asked to note whether s/he felt that her/his hearing was 'better', 'the same' or 'worse' than the week before or was 'fluctuating [16]'.
-Tinnitus will be scored as: 'none', 'mild', 'moderate' or 'severe'.
-Pressure sensation will be scored as 'none', 'mild', 'moderate' or 'severe'.
-At the end of the study, the investigators’ and patients’ overall judgments respectively on treatment efficacy and acceptance (five-point scale: 0= null, 1= poor, 2= moderate, 3= good, 4= very good) and the doctor’s preparedness to treat the patient again with the same treatment.

-Número de días asintomáticos (sin ataques de vértigo) durante el periodo de tratamiento.
-Tasa de pacientes con todos los ítems del GISFaV iguales a 0 a los 3 meses.
-Cambio en el número de ataques de vértigo mensuales durante el período de tratamiento.
-Escala de valoración del Inventario de Dificultades de Vértigo (DHI) [13] para la identificación de las dificultades que los pacientes encuentran durante la enfermedad vertiginosa.
-La audición se puntuará como: 'buena', 'ligeramente deteriorada', 'moderadamente deteriorada' o 'gravemente deteriorada'. Además, se pedirá al paciente que anote si considera que su audición es "mejor", "igual" o "peor" que la semana anterior o si es "fluctuante [16]".
-Los acúfenos se puntuarán como: "ninguno", "leve", "moderado" o "grave".
-La sensación de presión se calificará como "ninguna", "leve", "moderada" o "grave".
-Al final del estudio, las valoraciones globales de los investigadores y de los pacientes, respectivamente, sobre la eficacia y la aceptación del tratamiento (escala de cinco puntos: 0= nula, 1= mala, 2= moderada, 3= buena, 4= muy buena) y la disposición del médico a volver a tratar al paciente con el mismo tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

End of study

Al final del estudio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

Last visit of the last patient

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 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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

114

F.4.2

For a multinational trial

F.4.2.1

In the EEA

340

F.4.2.2

In the whole clinical trial

340

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

Ninguno

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

2021-12-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-23

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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