Clinical Trials Register

Summary
EudraCT Number:	2015-002142-31
Sponsor's Protocol Code Number:	547-SSE-301
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:	2015-11-05
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

2015-002142-31

A.3

Full title of the trial

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAGE-547 INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS

ESTUDIO ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO, DIRIGIDO A EVALUAR LA EFICACIA Y LA SEGURIDAD DE SAGE-547 INYECTABLE EN EL TRATAMIENTO DE PACIENTES QUE PADECEN ESTADO EPILÉPTICO SÚPER-REFRACTARIO (EESR)

A.3.1

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

CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A NEW DRUG (SAGE-547) INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS

Estudio clínico para evaluar la eficacia y seguridad del nuevo fármaco (SAGE-547) para inyección en el tratamiento de sujetos con estado epiléptico super-refractario

A.3.2

Name or abbreviated title of the trial where available

STATUS trial

A.4.1

Sponsor's protocol code number

547-SSE-301

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02477618

A.5.4

Other Identifiers

Name:

IND number

Number:

117901

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	Sage Therapeutics
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	SAGE THERAPEUTICS
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	SAGE Therapeutics
B.5.2	Functional name of contact point	Medical Director
B.5.3	Address:
B.5.3.1	Street Address	215 First Street
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	MA 02142
B.5.3.4	Country	United States
B.5.4	Telephone number	001617229-5234

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.3.2	Product code	SAGE-547
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not available yet
D.3.9.1	CAS number	516-54-1
D.3.9.2	Current sponsor code	SAGE-547
D.3.9.3	Other descriptive name	allopregnanolone
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	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.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	Solution for injection/infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

SUPER-REFRACTORY STATUS EPILEPTICUS (SRSE)

estado epiléptico súper-refractario (EESR)

E.1.1.1

Medical condition in easily understood language

STATUS EPILEPTICUS NOT RESPONDING TO ANY OF THE CONVENTIONAL THERAPY REGIMEN

Estado epiléptico que no responde al régimen de la terapia convencional

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	18.1
E.1.2	Level	PT
E.1.2	Classification code	10041962
E.1.2	Term	Status epilepticus
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the response to a 144-hour (6 day) continuous intravenous infusion of SAGE-547 compared to placebo administered to support the weaning of all third-line agents in adult and pediatric subjects with SRSE, and for the response to endure at least 24 hours after cessation of the SAGE-547 or placebo infusion (primary response).

Determinar la respuesta a una infusión intravenosa continua de 144 horas (6 días) de SAGE-547 con respecto al placebo, administrada para favorecer el retiro de todos los fármacos de tercera línea en pacientes adultos y pediátricos que padecen EESR, e inducir una duración de la respuesta de al menos 24 horas después de la conclusión de la infusión de SAGE-547 o placebo (respuesta primaria).

E.2.2

Secondary objectives of the trial

To compare between SAGE-547 and placebo: time between meeting primary response endpoint and re-institution of any third-line agent for seizure or burst suppression up to V12; secondary response, (success of weaning the subject off all third-line agents before end of the first infusion; time between meeting the secondary response endpoint and re-institution of any third-line agent for seizure or burst suppression up to V12; Change in the Clinical Global Impression scale up to V12; number of days after the end of the first infusion of study drug that the subject does not have status epilepticus, up to V12; number of days after end of the first infusion of study drug that the subject does not have seizures (convulsive and non-convulsive) up to V12; number of separate episodes of status epilepticus occurring up to V12; the proportion of subjects with a new diagnosis of epilepsy after V11.
To determine safety and tolerability of a 144-hour infusion of SAGE-547.

Para comparar entre SAGE-547 y el placebo: el tiempo entre la satisfacción de endpoint respuesta primaria y volver a la institución de cualquier agente de tercera línea para la incautación o la supresión de ráfaga de hasta V12; respuesta secundaria, (éxito de destete el tema de todos los agentes de tercera línea antes del final de la primera infusión, el tiempo entre la satisfacción de la variable respuesta secundaria y volver a la institución de cualquier agente de tercera línea para la incautación o la supresión de ráfaga de hasta V12; Cambio en escalar la impresión Clínica Global hasta V12, el número de días después del final de la primera infusión del fármaco del estudio que el sujeto no tiene el estado epiléptico, hasta V12, el número de días después del final de la primera infusión del fármaco del estudio que el sujeto no tiene convulsiones (convulsivos y no convulsivas) hasta V12, el número de episodios separados de estado que ocurren epiléptico hasta V12

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Pharmacogenomic sub-study. Included in the main study protocol version amendment 1 dated 27 May 2015.

The objective of this research is to collect and store blood sample for possible DNA extraction and exploratory research into how genes or specific genetic variation may influence response (i.e. distribution, safety, tolerability, and efficacy) to SAGE-547.

Subestudio farmacogenómica. Incluido en la versión del protocolo de estudio principal enmienda 1 de fecha 27 de mayo de 2015. El objetivo de esta investigación es recoger y almacenar muestras de sangre para la posible extracción de ADN y la investigación exploratoria sobre cómo los genes o la variación genética específica pueden influir en la respuesta (es decir, la distribución, la seguridad, tolerabilidad y eficacia) de SAGE-547

E.3

Principal inclusion criteria

1. Subjects two (2) years of age and older.
2. Subjects who have:
? Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to institution standard of care, and;
? Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED), according to institution standard of care, and;
? Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agent and in an EEG burst suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on a continuous intravenous infusion of at least one third-line agent or are on a continuous intravenous infusion of one or more third-line agent but not in an EEG burst suppression pattern

1.dos (2) o más años de edad;
2.pacientes:
?que no hayan tenido respuesta alguna a la administración de al menos un fármaco de primera línea (por ejemplo, benzodiazepina u otro tratamiento inicial de emergencia con drogas antiepilépticas [DAE]), según el tratamiento estándar utilizado por la estructura sanitaria;
?que no hayan tenido respuesta alguna a al menos un tratamiento con un fármaco de segunda línea (por ejemplo, fenitoina, fosfenitoina, valproato, fenobarbital, levetiracetam u otras DAE para el control urgente de los síntomas), según el tratamiento estándar utilizado por la estructura sanitaria;
?a los que no se haya administrado previamente un fármaco de tercera línea, pero que hayan sido hospitalizados en una Unidad de Terapia Intensiva para ser tratados con al menos un fármaco de tercera línea durante al menos 24 horas; o que hayan sido sometidos previamente, sin éxito, a uno o más intentos de retiro de fármacos de tercera línea y que actualmente estén en tratamiento con infusiones intravenosas continuas de uno o más fármacos de tercera línea, con patrón de supresión de crisis en el EEG; o que hayan sido sometidos previamente, sin éxito, a uno o más intentos de retiro de fármacos de tercera línea y que actualmente no estén en tratamiento con una infusión intravenosa continua de al menos un fármaco de tercera línea o estén en tratamiento con una infusión intravenosa continua de uno o más fármacos de tercera línea pero sin patrón de supresión de crisis en el EEG.

E.4

Principal exclusion criteria

1. Subjects who are pregnant.
2. Subjects with a known allergy to progesterone or allopregnanolone.
3. Subjects with SRSE due to anoxic/hypoxic encephalopathy.
4. Children (subjects aged less than 17 years) with an encephalopathy due to a rapidly progressing underlying neurological disorder.
5. Subjects who have any of the following:
-GFR low enough to warrant dialysis but for whatever reason, dialysis is not planned or non-continuous dialysis planned (that would not adequately remove Captisol®);
-severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
-fulminant hepatic failure;
-no reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the experience of the investigator, is less than 30 days;
-a do not resuscitate (DNR) order.
6. Subjects who are being administered more than three third-line agents concomitantly or for whom the qualifying wean cannot be completed within 24 hours or who are being administered a third-line agent for indications such as raised intra-cranial pressure that would preclude weaning according to this protocol.
7. Subjects with a living will that does not allow heroic measure.
8. Subjects who have been exposed to an investigational medication or device within 30 days; the exception to this is that participation in the Established Status Epilepticus Treatment Trial or ESETT within 30 days of screening for the 547-SSE-301 trial is allowed.
9. Subjects who have been enrolled in this trial or any other trial employing SAGE-547 previously (i.e., subjects may not withdraw or complete and then re-enroll).

1.mujeres embarazadas;
2.alergia conocida a la progesterona, a la alopregnanolona o a uno cualquiera de los excipientes de SAGE-547;
3.EESR causado por encefalopatía anóxica/hipóxica;
4.menores de edad (menos de 17 años) con encefalopatía causada por una patología neurológica preexistente de rápida evolución;
5.evidencia de una de las siguientes condiciones:
a.baja velocidad de filtración glomerular (FGR), suficiente para justificar la diálisis por cualquier motivo; de todos modos, el tratamiento dialítico no está previsto o está previsto un tratamiento dialítico no continuo (esto no permitiría una adecuada eliminación del Captisol®);
b.grave choque cardiogénico o vasodilatatorio que requiera dos o más vasopresores, no relacionado con el uso del fármaco de tercera línea;
c.insuficiencia hepática fulminante;
d.ninguna expectativa razonable de recuperación (por ejemplo, si el resultado probable es un estado vegetativo persistente) o expectativa de vida (a juicio del investigador) inferior a 30 días;
e.orden de no reanimar (Do Not Resuscitate, DNR);
6.actual administración concomitante de más de tres fármacos de tercera línea, imposibilidad de alcanzar el QW en las 24 horas o administración actual de un fármaco de tercera línea para otras indicaciones (como el tratamiento del aumento de la presión intracraneal), que podría impedir el retiro según el presente protocolo;
7.testamento biológico que prohíba el ensañamiento terapéutico;
8.exposición a un fármaco o dispositivo experimental en los 30 días previos a la fase de cribado; de todos modos, se permite la participación en la experimentación clínica ESETT (Established Status Epilepticus Treatment Trial) en los 30 días previos a la fase de cribado para el estudio 547-SSE-301;
9.reclutamiento previo para este estudio o para cualquier otra experimentación clínica sobre el uso de SAGE-547 (por ejemplo, los pacientes no podrán completar o retirarse de este estudio y, a continuación, participar nuevamente en el reclutamiento para el mismo).

E.5 End points

E.5.1

Primary end point(s)

Success or failure, with success defined as weaning the subject off all third-line agents before completion of the first blinded infusion of SAGE-547 or placebo, and not having to re-institute any third-line agent for seizure or burst suppression during the 24 hours after the end of the first infusion of SAGE-547 or placebo, and concurrent signs of physiologic brain activity as determined by EEG (primary response).

Éxito o fracaso terapéutico, entendiéndose por ?éxito terapéutico? el retiro al paciente de todos los fármacos de tercera línea antes de la conclusión de la primera infusión de SAGE-547 o placebo administrada en ciego, y para los cuales no subsiste la necesidad de restablecer un tratamiento con cualquier fármaco de tercera línea para el control de las crisis epilépticas o la obtención de una actividad de supresión de crisis durante las 24 horas siguientes a la conclusión de la primera infusión de SAGE-547 o placebo, con evidencia asociada de signos concomitantes de actividad fisiológica cerebral evaluada mediante EEG (respuesta primaria).

E.5.1.1

Timepoint(s) of evaluation of this end point

24 hours after the end of study drug infusion.

24 horas siguientes a la conclusión de la infusión de SAGE-547

E.5.2

Secondary end point(s)

1. The time between meeting the primary response endpoint and the re-institution of any third-line agent for seizure or burst suppression up to Visit 12;
2. Secondary response, defined as success of weaning the subject off all third-line agents before the end of the first SAGE-547 or placebo infusion;
3. The time between meeting the secondary response endpoint, defined in (2) above, and the re-institution of any third-line agent for seizure or burst suppression up to Visit 12;
4. The assessment of clinical status as measured by change in the CGI from Visit 1 (Screening) and to Visit 12;
5. The number of days after the end of the first study drug infusion that the subject does not have status epilepticus, up to Visit 12;
6. The number of days after the end of the first study drug infusion that the subject does not have seizures (convulsive and non-convulsive) up to Visit 12;
7. The number of separate episodes of status epilepticus occurring up to Visit 12;
8. The proportion of subjects with a new diagnosis of epilepsy after Visit 11.

Safety endpoints:
1.Adverse events and medications;
2.Laboratory testing (hematology, serum chemistry, and urinalysis);
3.Vital signs (blood pressure, heart rate, temperature, and weight);
4.ECG parameters;
5.Mortality.

1.tiempo transcurrido entre el cumplimiento del criterio de valoración principal de respuesta y el restablecimiento del tratamiento con cualquier fármaco de tercera línea para el control de las crisis epilépticas o la obtención de una actividad de supresión de crisis hasta la consulta 12;
2.respuesta secundaria, definida como el retiro exitoso al paciente de todos los fármacos de tercera línea antes de la conclusión de la primera infusión de SAGE-547 o placebo;
3.tiempo transcurrido entre el cumplimiento del criterio de valoración secundario de respuesta, según lo definido en el anterior punto (2), y el restablecimiento del tratamiento con cualquier fármaco de tercera línea para el control de las crisis epilépticas o la obtención de una actividad de supresión de crisis hasta la consulta 12;
4.evaluación del estado clínico global del paciente, expresada sobre la base de la variación en la escala CGI entre la consulta 1 (cribado) y la consulta 12;
5.número de días después de la conclusión de la primera infusión del fármaco en estudio, durante los cuales el paciente no se encuentra en estado epiléptico, hasta la consulta 12;
6.número de días después de la conclusión de la primera infusión del fármaco en estudio, durante los cuales el paciente no sufre crisis epilépticas (convulsivas y no convulsivas), hasta la consulta 12;
7.número de episodios separados de epilepsia hasta la consulta 12;
8.porcentaje de pacientes con un nuevo diagnóstico de epilepsia después de la consulta 11.

Criterios de evaluación de seguridad:
1.eventos adversos y tratamientos farmacológicos;
2.análisis de laboratorio (hematología, química sérica y examen de orina);
3.signos vitales (presión arterial, frecuencia cardiaca, temperatura corporal y peso);
4.parámetros ECG;
5.mortalidad.

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy: up to visit 12 or after visit 11 for end-point # 8.
Safety:
AEs and medications: V1-V12
ECG and vital signs: V1, V3-V10
Lab tests: V1, V3, V4, V6, V8, V10,V11
Mortality: V12

Retreatment period:
AE and medications: V3R-V12R
ECG and vital signs: V3R-V10R
Lab tests: V3R, V4R, V6R, V8R, V10R, V11R
Mortality: V12R

Eficacia: hasta la visita 12 or después de la visita 11 para el criterio de valoración nº 8.
Seguridad:
EAs y medicamentos: V1-V12
ECG y signos vitales: V1, V3-V10
Pruebas de laboratorio: V1, V3, V4, V6, V8, V10,V11
Mortalidad: V12.

Periodo de re-tratamiento:
EAs y medicamentos: V1-V12: V3R-V12R
ECG y signos vitales: V3R-V10R
Pruebas de laboratorio: V3R, V4R, V6R, V8R, V10R, V11R
Mortalidad: V12R?

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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)

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

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

Belgium

Canada

Denmark

France

Germany

Sweden

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

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)

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-11-05.

Yes

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subjects are unlikely to be able to consent themselves for the study due to coma or mental incapacity

Es improbable que estos pacientes puedan prestar autónomamente su consentimiento, a causa de condiciones de coma o incapacidad mental a causa del estado epiléptico.

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)

According to standard of care

De acuerdo al estándar de atención

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

2015-12-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-04

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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