Clinical Trials Register

Summary
EudraCT Number:	2020-002769-33
Sponsor's Protocol Code Number:	EP0132
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:	2025-01-30
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

2020-002769-33

A.3

Full title of the trial

A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Estudio multicéntrico, abierto y de un solo grupo para evaluar la seguridad, la tolerabilidad y la eficacia de brivaracetam a largo plazo en los participantes del estudio con edades comprendidas entre 2 y 26 años con epilepsia de ausencia infantil o epilepsia de ausencia juvenil

A.3.1

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

A study to test the long-term safety, tolerability and efficacy of brivaracetam in study participants 2 to 26 years of age with with childhood absence epilepsy or juvenile absence epilepsy.

Estudio de eficacia, seguridad y tolerabilidad a largo plazo de brivaracetam como monoterapia en participantes del estudio con edades comprendidas entre 2 y 26 años con epilepsia de ausencia infantil o juvenil

A.4.1

Sponsor's protocol code number

EP0132

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	UCB Biopharma SRL
B.1.3.4	Country	Belgium
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	UCB Biopharma SRL
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	UCB BIOSCIENCES GmbH
B.5.2	Functional name of contact point	Clin Trial Reg & Results Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Alfred-Nobel-Strasse 10
B.5.3.2	Town/ city	Monheim
B.5.3.3	Post code	40789
B.5.3.4	Country	Germany
B.5.4	Telephone number	+34638210511
B.5.6	E-mail	clinicaltrials@ucb.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	Briviact
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma S.A.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Oral solution
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	BRIVARACETAM
D.3.9.1	CAS number	357336-20-0
D.3.9.2	Current sponsor code	BRV
D.3.9.3	Other descriptive name	Briviact
D.3.9.4	EV Substance Code	SUB25397
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	Yes
D.2.1.1.1	Trade name	Briviact
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma S.A.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	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	BRIVARACETAM
D.3.9.1	CAS number	357336-20-0
D.3.9.2	Current sponsor code	BRV
D.3.9.3	Other descriptive name	Briviact
D.3.9.4	EV Substance Code	SUB25397
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: 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	Briviact
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma S.A.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	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	BRIVARACETAM
D.3.9.1	CAS number	357336-20-0
D.3.9.2	Current sponsor code	BRV
D.3.9.3	Other descriptive name	Briviact
D.3.9.4	EV Substance Code	SUB25397
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	25
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	Briviact
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma S.A.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	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	BRIVARACETAM
D.3.9.1	CAS number	357336-20-0
D.3.9.2	Current sponsor code	BRV
D.3.9.3	Other descriptive name	Briviact
D.3.9.4	EV Substance Code	SUB25397
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	50
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

Childhood absence epilepsy (CAE)
Juvenile absence epilepsy (JAE)

Epilepsia de ausencia infantil
Epilepsia de ausencia juvenil

E.1.1.1

Medical condition in easily understood language

Absence seizures are a type of seizure that involves brief, sudden lapses in attention. Symptoms include staring into space for a few seconds, lip smacking, eyelid fluttering, and chewing motions.

Las crisis de ausencia implican lapsus de atención breves y repentinos. Síntomas:mirar al espacio fijamente durante unos segundos, fruncir los labios, parpadear y hacer movimientos de masticación.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Investigate the long-term safety and tolerability of brivaracetam in pediatric study participants with childhood absence epilepsy or juvenile absence epilepsy.

Investigar la seguridad y tolerabilidad a largo plazo del brivaracetam en los participantes del estudio pediátrico con epilepsia de ausencia infantil o epilepsia de ausencia juvenil.

E.2.2

Secondary objectives of the trial

Investigate long-term efficacy of BRV pediatric study participants with childhood absence epilepsy or juvenile absence epilepsy.

Investigar la eficacia a largo plazo de los participantes del estudio pediátrico BRV con epilepsia de ausencia infantil o epilepsia de ausencia juvenil.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Participants who previously participated in N01269 and qualify for entry into EP0132 as per N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE), and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected, in the opinion of the Investigator
− A sexually active male study participant must agree to use contraception during the treatment period and for at least 2 days, corresponding to the time needed to eliminate study treatment, after the last dose of study treatment and refrain from donating sperm during this period
− A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
1. The study participant is premenarchal
OR
2. A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study medication, corresponding to the time needed to eliminate study treatment
- Study participant is capable of and provides consent/assent, and the study participant’s parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Participantes que participaron previamente en N01269 y califican para ingresar a EP0132 según el protocolo N01269 con un diagnóstico confirmado de epilepsia de ausencia infantil (CAE) o epilepsia de ausencia juvenil (JAE), y para quienes un beneficio razonable de la administración a largo plazo de brivaracetam ( BRV) se espera, en opinión del Investigador - Un participante masculino sexualmente activo del estudio debe aceptar usar anticonceptivos durante el período de tratamiento y durante al menos 2 días, correspondiente al tiempo necesario para eliminar el tratamiento del estudio, después de la última dosis del tratamiento del estudio y abstenerse de donar esperma durante este período. - Una participante del estudio es elegible para participar si no está embarazada, no está amamantando, y se aplica al menos 1 de las siguientes condiciones: 1. El participante del estudio es premenárquico O 2. Una mujer en edad fértil (WOCBP) que acepta seguir la guía anticonceptiva durante el período de tratamiento y durante al menos 2 días después de la última dosis del medicamento del estudio, correspondiente al tiempo necesario para eliminar el tratamiento del estudio. - El participante del estudio es capaz y proporciona consentimiento / asentimiento, y el padre / representante legal / cuidador del participante del estudio proporciona un consentimiento informado firmado para los participantes menores del estudio, que incluye el cumplimiento de los requisitos y restricciones enumerados en el formulario de consentimiento informado (ICF) y en este protocolo

E.4

Principal exclusion criteria

- Study participant has a history or presence of paroxysmal nonepileptic seizures
- Study participant has severe medical, neurological, or psychiatric disorders or laboratory values, which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation
- Study participant has active suicidal ideation prior to study entry as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) or clinical judgment (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional
- Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). The Investigator must immediately refer the study participant to a Mental Healthcare Professional
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study
- Participant has a known hypersensitivity to any components of brivaracetam (BRV) or excipients or a drug with similar chemical structure. Note that the tablets contain lactose
- Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
- Study participant has planned participation in any clinical study on an investigational drug or device
- Study participant has poor compliance with the visit schedule or medication intake in the core study in the opinion of the Investigator

El participante del estudio tiene antecedentes o presencia de convulsiones paroxísticas no epilépticas - El participante del estudio tiene trastornos médicos, neurológicos o psiquiátricos graves o valores de laboratorio que podrían, a discreción del investigador, afectar la participación segura en el estudio o impedir la participación adecuada en el estudio. - El participante del estudio tiene una ideación suicida activa antes de ingresar al estudio, como lo indica una respuesta positiva ("Sí") a la Pregunta 4 o la Pregunta 5 de la Escala de calificación de gravedad del suicidio de Columbia (C-SSRS) (para participantes del estudio de 6 años o más) o juicio clínico (para participantes del estudio menores de 6 años). El participante del estudio debe ser derivado inmediatamente a un profesional de la salud mental. - El participante del estudio tiene un historial de intentos de suicidio de por vida (incluido un intento activo, un intento interrumpido o un intento abortado). El investigador debe derivar inmediatamente al participante del estudio a un profesional de la salud mental. - El participante tiene alguna condición médica o psiquiátrica que, en opinión del investigador, podría peliglitazar o comprometería la capacidad del participante del estudio para participar en este estudio. - El participante tiene hipersensibilidad conocida a cualquier componente de brivaracetam (BRV) o excipientes o un fármaco con estructura química similar. Tenga en cuenta que las tabletas contienen lactosa - Uso concomitante de carbamazepina, felbamato, gabapentina, oxcarbazepina, fenobarbital, fenitoína, tiagabina o vigabatrina. - El participante del estudio ha planificado su participación en cualquier estudio clínico sobre un medicamento o dispositivo en investigación. - En opinión del investigador, el participante del estudio no cumple con el programa de visitas o la ingesta de medicamentos en el estudio principal

E.5 End points

E.5.1

Primary end point(s)

1. Percentage of participants with treatment-emergent adverse events (TEAEs)
2. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment

1. Porcentaje de participantes con eventos adversos emergentes del tratamiento (TEAE)
2. Porcentaje de participantes con eventos adversos emergentes del tratamiento (TEAE) que llevaron a la interrupción del tratamiento del estudio

E.5.1.1

Timepoint(s) of evaluation of this end point

1: From Entry Visit up to the Safety Visit (Month 26)
2: From Entry Visit until End of Down-Titration Period (Month 26)

1: Desde la visita de entrada hasta la visita de seguridad (mes 26)
2: Desde la visita inicial hasta el final del período de titulación (mes 26)

E.5.2

Secondary end point(s)

1. Percentage of participants with serious adverse events (SAEs) during the study
2. Percentage of participants with study drug-related treatment-emergent adverse events (TEAEs)
3. Percentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit
4. Percentage of participants meeting the criteria for absence seizure freedom based on diary over the entire evaluation period and 3-month time intervals

1. Porcentaje de participantes con eventos adversos Serios (AAG) durante el estudio
2. Porcentaje de participantes con eventos adversos emergentes del tratamiento relacionados con el fármaco del estudio (TEAE)
3. Porcentaje de participantes con ausencia de crisis convulsivas dentro de los 4 días antes o durante el electroencefalograma (EEG) de 1 hora en cada visita correspondiente
4. Porcentaje de participantes que cumplen los criterios para la ausencia de convulsiones según el diario durante todo el período de evaluación y los intervalos de tiempo de 3 meses

E.5.2.1

Timepoint(s) of evaluation of this end point

1 + 2: From Entry Visit up to the Safety Visit (Month 26)
3: From Full Evaluation Visit (Month 6) up to the Final Visit (Month 24)
4: From Entry Visit up to the Final Visit (Month 24)

1 + 2: desde la visita de entrada hasta la visita de seguridad (mes 26)
3: Desde la visita de evaluación completa (mes 6) hasta la visita final (mes 24)
4: Desde la visita de entrada hasta la visita final (mes 24)

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

Yes

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tolerabilidad

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

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

Ukraine

Australia

Georgia

United States

Belgium

Hungary

Italy

Poland

Romania

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

LVLS

UPUV

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

112

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

140

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

2021-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-20

P. End of Trial
P.	End of Trial Status	Completed

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