Clinical Trials Register

Summary
EudraCT Number:	2015-005469-22
Sponsor's Protocol Code Number:	TEMPO-2
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:	2016-09-09
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

2015-005469-22

A.3

Full title of the trial

Multi-Centre, prosepective randomised open label, blinded-endpoint (PROBE) controlled trial of thrombolysis with low dose Tenecteplase (TNK-tPA) versus standard of care in the prevention of disability at 3 months in minor ischemic stroke with proven acute symptomatic occlusion.

Ensayo multicentrico, prospectivo, aleatorizado, abierto, de evaluación de resultados cegados (PROBE), controlado, de trombolisis a dosis bajas de Tenecteplasa (TNK-tPa) frente a la práctica clínica habitual en la prevención de la discapacidad a los 3 meses de haber sufrido un ictus minor con evidencia de oclusión.

A.3.1

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

A randomised controlled trial of TNK-tPA versus standard of care for minor ischemic stroke with proven occlusion.

Ensayo controlado aleatorizado de Tenecteplasa (TNK-tPa) frente a la práctica clínica habitual para ictus minor con evidencia de oclusión.

A.3.2

Name or abbreviated title of the trial where available

TEMPO-2

A.4.1

Sponsor's protocol code number

TEMPO-2

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	University of Calgary
B.1.3.4	Country	Canada
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	University of Calgary
B.4.2	Country	Canada
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University of Calgary
B.5.2	Functional name of contact point	Dr Shelagh B. Coutts
B.5.3	Address:
B.5.3.1	Street Address	C1242, Foothills Medical Centre, 1403 29th St NW
B.5.3.2	Town/ city	Calgary, AB
B.5.3.3	Post code	T2N 2T9
B.5.3.4	Country	Canada
B.5.4	Telephone number	14039441594
B.5.5	Fax number	14039443079
B.5.6	E-mail	scoutts@ucalgary.ca

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	Metalyse 10, 000 U Powder and solvent for solution for injection Tenecteplase (TNK-tPA)
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingleheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Ireland
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	Metalyse 10,000 U
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TENECTEPLASE
D.3.9.1	CAS number	191588-94-0
D.3.9.4	EV Substance Code	SUB04718MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10 000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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

To demonstrate the efficacy of using TNK-tPA (tenecteplase), a thrombolytic agent that is relatively novel to the treatment ischemic stroke but well-established in the treatment of myocardial infarction, to treat minor ischemic stroke patients with proven acute symptomatic occlusions or perfusion abnormalities.

Demostrar la eficacia de utilizar Tenecteplasa (TNK-tPa), un agente trombolítico relativamente nuevo para el tratamiento el ictus isquémico, pero bien establecido en el tratamiento de infarto de miocardio, para tratar el ictus isquémico menor con oclusión arterial aguda demostrada o anormalidades en la perfusión.

E.1.1.1

Medical condition in easily understood language

To demonstrate the efficacy of using TNK-tPA to treat minor ischemic stroke with proven arterial occlusion.

Demostrar la eficacia de utilizar Tenecteplasa (TNK-tPa) para tratar el ictus isquémico menor con oclusión arterial demostrada.

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

The primary objective: to demonstrate the efficacy of using TNK-tPA to treat minor ischemic stroke with proven arterial occlusion.

El objetivo principal: demostrar la eficacia de utilizar TNK-tPA para tratar el ictus isquémico menor con oclusión arterial demostrada.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Acute ischemic stroke in an adult patient (18 years of age or older)
2. Onset (last-seen-well) time to treatment time ≤ 12 hours.
3. Transient Ischemic Attack or minor stroke defined as a baseline National Institutes of Health Stroke Scale (NIHSS) ≤ 5 at the time of randomization. Patients do not have to have persistent demonstrable neurological deficit on physical neurological examination.
4. Any acute intracranial occlusion or near occlusion (Thrombolysis in cerebral ischemia (TICI) 0 or 1) (Middle Cerebal Artery, Anterior Cerebral Artery, Posterior Cerebral Artery, Vertebrobasilar territories) defined by non-invasive acute imaging Computed Tomography Angiography (CTA) or Magnetic Resonance angiography (MRA) ) that is neurologically relevant to the presenting symptoms and signs. Multiphase Computed Tomographic Angiography (CTA) or Computed Tomography (CT) perfusion are required for this study. An acute occlusion is defined as TICI 0 or TICI 1 flow.1 Practically this can include a small amount of forward flow in the presence of a near occlusion
AND,
Delayed washout of contrast with pial vessels on multiphase CTA in a region of brain concordant
with clinical symptoms and signs OR,
Any area of focal perfusion abnormality identified using CT or MR perfusion – e.g. transit delay (Time To Peak (TTP), Mean Transit Time (MTT) or Time to Peak of the impulse response (T Max) ), in a region of brain concordant with clinical symptoms and signs.
5. Pre-stroke independent functional status-structured Modified Rankin Scale mRS ≤2.
6. Informed consent from the patient or surrogate.
7. Patients can be treated within 90 minutes of the first slice of CT or MRI. Scans can be repeated
to meet this requirement; if there is no change neurologically then only a CT head need be repeated
for assessment of extent and depth of ischemia.

1. Ictus isquémico agudo en un paciente adulto (a partir de 18 años)
2. El intervalo de tiempo desde la aparición (inicio de los síntomas) hasta el tratamiento es de ≤ 12 horas.
3. AIT o accidente cerebrovascular menor definido como NIHSS basal ≤ 5 en el momento de aleatorización. Los pacientes no necesitan presentar ningún déficit neurológico permanente demostrable en el examen neurológico físico.
4. Cualquier oclusión intracraneal aguda o casi oclusión (TICI 0 ó 1) (territorios de ACM, ACA, ACP y VB) definida por imágenes agudas no invasivas (angiografía por TC o RM) que sea neurológicamente relevante para los síntomas e indicios manifestados. Una oclusión aguda está definida como flujo TICI 0 o TICI 11. En la práctica, puede incluir una pequeña cantidad de flujo de avance ante la presencia de una casi oclusión, Y
Lavado retardado de contraste con los vasos piales en angiografía tomográfica computorizada (ATC) de múltiples fases, en una región del cerebro que concuerda con los indicios o síntomas clínicos, O BIEN
Cualquier área de anormalidad de perfusión focal identificada mediante perfusión de RM o TC – p. ej. retardo de tránsito (TTP, MTT o TMax) en una región del cerebro que concuerda con los indicios o síntomas clínicos.
5. Estado funcoinal independiente previo al accidente cerebrovascular – mRS ≤ 2.
6. Consentimiento fundamentado.
7. Los pacientes pueden ser tratados dentro de los 90 minutos siguientes al primer corte de TC (o RM).

E.4

Principal exclusion criteria

1. Hyperdensity on NCCT consistent with intracranial hemorrhage.
2. Large acute stroke ASPECTS < 7 visible on baseline CT scan.
3. Core of established infarction. No large area (estimated > 10 cc) of grey matter hypodensity at
a similar density to white matter or in the judgment of the enrolling neurologist is consistent with a subacute ischemic stroke > 12 hours of age.
4. Clinical history, past imaging or clinical judgment suggest that that intracranial occlusion is chronic.
5. Patient has a severe or fatal or disabling illness that will prevent improvement or follow-up or such that the treatment would not likely benefit the patient.
6. Pregnancy
7. Planned thrombolysis with IV tPA or endovascular thrombolysis/thrombectomy treatment.
8. In-‐hospital stroke unless these patients are at their baseline prior to their stroke.E.g. a patient who had a stroke during a diagnostic coronary angiogram.
9. Commonly accepted exclusions for medical thrombolytic treatment. These are commonly relative
contraindications (i.e. the final decision is at the discretion of the treating physician) but for
the purposes of TEMPO-2 include the following:
a. International normalized ratio > 1.7 or known full anticoagulation with use of any standard or novel anticoagulant therapy with fullanticoagulant dosing. [DVT prophylaxis dosing shall not prohibit enrolment]. For LMWH or the novel anticoagulants, more than 48 hours off drug will be considered sufficient to allow trial enrollment. Dual antiplatelet therapy does not prohibit enrolment. [For patients who are known not to be taking anticoagulant therapy it is not necessary to wait for coagulation lab results (e.g. PT, PTT) prior to treatment]
b. Patients who have been acutely treated with GP2b3a inhibitors.
c. Arterial puncture at a non-compressible site in the previous seven days
d. Clinical stroke or serious head or spinal trauma in the preceding three months that would normally preclude use of a thrombolytic agent.
e. History of intracranial hemorrhage, subarachnoid hemorrhage or other brain hemorrhage that would
normally preclude use of a thrombolytic agent.
f. Major surgery within the last 3 months at a bodily site where bleeding
could result in serious harm or death.

1. Hiperdensidad en tomografía computarizada sin contraste coincidente con una hemorragia intracraneal.
2. Gran accidente cerebrovascular agudo de ASPECTS < 7, visible en la TC basal.
3. Núcleo del infarto determinado. No se trata de una zona grande (se calcula > 10 cc) de hipodensidad de materia gris a una densidad similar a la materia blanca o, de acuerdo con el criterio del neurólogo responsable, coincide con un ictus isquémico subagudo.
4. El paciente presenta una enfermedad severa, fatal o incapacitante que impedirá su movimiento o seguimiento, o que provocará que el tratamiento tenga pocas posibilidades de beneficiar al paciente.
5. Embarazo.
6. Trombólisis planeada con tPA intravenosa o tratamiento agudo endovascular.
7. Accidente cerebrovascular durante hospitalización, excepto si esos pacientes se encuentran en su nivel de base antes del accidente cerebrovascular.
8. Exclusiones aceptadas de manera común para el tratamiento médico trombolítico que incrementen potencialmente el riesgo de sangrado del paciente. Deben consultarse las monografías de productos para países específicos y directrices sobre trombólisis para accidentes cerebrovasculares. Son contraindicaciones normalmente relacionadas (p. ej. la decisión final depende del criterio del médico tratante, pero que, a los fines de TEMPO-2, incluyen lo siguiente:
a. Un trastorno hemorrágico significativo en la actualidad o en los últimos 6 meses
b. Relación internacional normalizada > 1,7 o anticoagulación completa conocida, con el uso de cualquier tratamiento anticoagulante estándar o novedoso, con dosis completa de anticoagulantes. [La dosis para la profilaxis de la TVP no prohibirá la admisión]. En el caso de heparinas de bajo peso molecular (LMWH) o anticoagulantes novedosos, más de 48 horas sin tomar el medicamento ser considerarán suficientes para permitir la admisión al ensayo. El tratamiento antiplaquetario dual no prohíbe la admisión. [Para pacientes sobre los cuales se sepa que no estén siguiendo ningún tratamiento antiplaquetario, no es necesario esperar los resultados del laboratorio sobre coagulación (p. ej. PT, PTT) antes del tratamiento]
c. Reanimación cardiopulmonar prolongada (> 2 minutos) en las últimas 2 semanas
d. Pericarditis aguda y/o endocarditis bacteriana subaguda
e. Pancreatitis aguda
f. Disfunción hepática severa, incluyendo insuficiencia hepática, cirrosis, hipertensión portal (varices esofágicas) y hepatitis activa
g. Neoplasma con incremento de riesgo de sangrado
h. Aneurisma arterial y malformación arterial o venosa conocida
i. Pacientes que hayan recibido un tratamiento agudo con inhibidores GP2b3a
j. Punción arterial en una ubicación no comprimible en los siete días previos
k. Accidente cardiovascular clínico o traumatismo craneal o vertebral en los tres meses precedentes que normalmente impida el uso de un agente trombolítico
l. Historial de hemorragia intracranial, hemorragia subarácnida u otra hemorragia cerebral que normalmente impida el uso de un agente trombolítico
m. Intervención quirúrgica importante en los últimos 3 meses, que el médico tratante considere una contraindicación para el tratamiento trombolítico
n. Hipoglicemia (< 50 mg/dL o 2,8 mmol/l) o hiperglicemia (> 400 o 22,2 mmol/l)
o. Hipertensión refractaria a fármacos hipertensores, de modo que no se puedan alcanzar los niveles de presión arterial previstos < 185/110 antes del tratamiento
p. Conteo de plaquetas conocido por debajo de 100.000 por milímetro cúbico. [El tratamiento no debería retardarse para esperar el conteo de plaquetas a menos que se conozca o se sospeche de trombocitopenia]
q. Hemorragias gastrointestinales o genitourinarias en los últimos 3 meses que normalmente impedirían el uso de un agente trombolítico

E.5 End points

E.5.1

Primary end point(s)

Primary outcome: Return to baseline neurological functioning as measured by the mRS.
Analysis will be a responder analysis where return to baseline level of neurological functioning is
defined as follows:
If pre-morbid mRS is 0-1 then mRS 0-1 at 90 days is a good outcome.
If pre-morbid mRS is 2 then mRS 0-2 is a good outcome.

Pre-morbid mRS is assessed using the structured mRS prior to randomization.
Outcomes will be assessed by an individual blinded to the treatment assignment. The 90day mRS will
be rated using the structured mRS questionnaire. The 90 day mRS will be completed
in person where possible and by telephone otherwise. The structured questionnaire has been showed
to improve reliability in assessing the mRS both in person and by telephone.

Resultado principal: Retorno al funcionamiento neurológico basal según el cálculo del mRS. El análisis será un análisis de paciente, donde el retorno al nivel basal del funcionamiento neurológico se definirá del modo siguiente:
Si el mRS premórbido es de 0-1, el mRS 0-1 a 90 días será un buen resultado.
Si el mRS premórbido es de 2, el mRS 0-2 será un buen resultado.
El mRS premórbido se calcula utilizando el mRS estructurado antes de la aleatorización.
Un evaluador ciego al tratamiento recibido por el paciente, evaluará el resultado funcional. El mRs a los 90 días se evaluará mediante el cuestionario estructurado. El mRs a los 90 días se evaluará en persona, siempre que sea posible o por telefono cuando no sea posible. El cuestrionario estructurado ha demostrado mejorar la fiabilidad de la realización de la escala mRs tanto cuando se realiza por telefono como en persona.

E.5.1.1

Timepoint(s) of evaluation of this end point

At day 90 day mRS will be completed in person where possible and by telephone otherwise. The structured questionnaire has been showed to improve reliability in assessing the mRS both in person and by telephone.

El mRs a los 90 días se evaluará en persona, siempre que sea posible o por telefono cuando no sea posible. El cuestrionario estructurado ha demostrado mejorar la fiabilidad de la realización de la escala mRs tanto cuando se realiza por telefono como en persona.

E.5.2

Secondary end point(s)

Secondary outcomes: Safety, recanalization, ordinal shift
analysis of mRS, NIHSS 0 at day 5 (or discharge), Euroqol, everyday activities sub-question on
Euroqol, Lawton Instrumental Activities of Daily Living Scale (IADL), all cause mortality,
recurrent stroke or progression, mRS 0-1 at 90days, mRS 0-2 at 90 days, mean mRS using linear
regression,
composite of recanalization or mRS 0-1 at 90days and mortality.

Resultados secundarios: seguridad, recanalización, análisis de cambio ordinal de mRS, NIHSS 0 en el 5.º día (o al alta), Euroqol, subpregunta sobre actividades diarias en Euroqol, Actividades Instrumentales de Lawton sobre la Escala de Vida Diaria (IADL). Todas ellas provocan mortalidad, recurrencia o desarrollo de accidentes cerebrovasculares, mRS 0-1 a los 90 días, mRS 0-2 a los 90 días, mRS medio usando la regresión lineal, compuesto de recanalización o mRS 0-1 a 90 días y mortalidad.

E.5.2.1

Timepoint(s) of evaluation of this end point

Assessments at Day 1, Day 5 or discharge and Day 90

Evaluaciones al Día 1, Día 5 o Alta y al Día 90.

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Prospective Randomised Open Label Blinded Endpoint Assessment

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

Yes

E.8.2.3.1

Comparator description

Standard Usual Care

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

Australia

Austria

Canada

Ireland

New Zealand

Spain

United Kingdom

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

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

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:

425

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

849

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 2016-09-09.

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

All patients or legally authorized surrogate will provide written informed consent.

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

200

F.4.2.2

In the whole clinical trial

1274

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)

All patients will be treated with the best practice usual care as deemed appropriate by their treating physician.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Irish Stroke Clinical Trial Network
G.4.3.4	Network Country	Ireland

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-02-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-11-25

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

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Orphan Designation Number:
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