Clinical Trials Register

Summary
EudraCT Number:	2014-002246-41
Sponsor's Protocol Code Number:	BP29420
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:	2015-03-03
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

2014-002246-41

A.3

Full title of the trial

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO6885247 FOLLOWING 12 WEEKS OF TREATMENT IN ADULT AND PEDIATRIC PATIENTS WITH SPINAL MUSCULAR ATROPHY (MOONFISH)

Estudio multicéntrico, aleatorizado, doble ciego controlado con placebo, de dosis múltiple, para evaluar la seguridad, tolerancia, farmacocinética y farmacodinámica, tras 12 semanas de tratamiento con RO6885247, en pacientes adultos y pediátricos con atrofia muscular espinal

A.3.1

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

A Study of RO6885247 in Adult and Pediatric Patients with Spinal Muscular Atrophy (MOONFISH)

Estudio de RO6885247 en adultos y pacientes pedíatricos con atrofia muscular espiral (MOONFISH)

A.3.2

Name or abbreviated title of the trial where available

MOONFISH

A.4.1

Sponsor's protocol code number

BP29420

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02240355

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	Roche Farma S.A., en nombre de F. Hoffmann-La Roche Ltd.
B.1.3.4	Country	Switzerland
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	F. Hoffmann-La Roche Ltd
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F. Hoffmann-La Roche Ltd.
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+34 91 325 73 00
B.5.6	E-mail	global.rochegenentechtrials@roche.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.3.2	Product code	RO6885247/F03
D.3.4	Pharmaceutical form	Powder for oral solution
D.3.4.1	Specific paediatric formulation	Yes
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	n.a.
D.3.9.1	CAS number	1449598-06-4
D.3.9.2	Current sponsor code	RO6885247
D.3.9.3	Other descriptive name	n.a.
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	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	RO6885247/F02
D.3.4	Pharmaceutical form	Powder for oral solution
D.3.4.1	Specific paediatric formulation	Yes
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	n.a.
D.3.9.1	CAS number	1449598-06-4
D.3.9.2	Current sponsor code	RO6885247
D.3.9.3	Other descriptive name	n.a.
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	200
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	Oral solution
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

Spinal Muscular Atrophy

Atrofia muscular espinal

E.1.1.1

Medical condition in easily understood language

Spinal Muscular Atrophy, a genetic progressive neuromuscular disease characterized by profound weakness and muscle atrophy that is the leading genetic cause of death in babies and toddlers.

Atrofia muscular espinal, enfermedad genética neuromuscular progresiva caracterizada por debilidad profunda y atrofia muscular que es la principal causa genética de muertes en bebés y niños.

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	18.0
E.1.2	Level	PT
E.1.2	Classification code	10041582
E.1.2	Term	Spinal muscular atrophy
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic 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 evaluate the safety and tolerability of 12 weeks treatment with RO6885247 in adult and pediatric patients with spinal muscular atrophy (SMA)

Evaluar la seguridad y la tolerancia de un tratamiento de 12 semanas con RO6885247 en pacientes adultos y pediátricos con atrofia muscular espinal (AME)

E.2.2

Secondary objectives of the trial

Pharmacokinetics
- To investigate the multiple-dose pharmacokinetics (PK) of RO6885247 and its metabolite(s), if appropriate
- To gain preliminary information on the potential effect of food on the PK of RO6885247

Pharmacodynamics
- To investigate pharmacodynamic (PD) effects of RO6885247 as assessed by Survival of Motor Neuron 2 (SMN2) splicing modification and increase in SMN protein
- To investigate the PK/PD relationship of RO6885247 by PK/PD modeling (PD to include SMN2 messenger RNA [mRNA] and SMN protein)
- To investigate the effect of 12 weeks of treatment with RO6885247 on muscle electrophysiology as assessed by Compound Muscle Action Potential (CMAP) (optional for patients aged 7 months or below)
- To investigate the effect of 12 weeks of treatment with RO6885247 on Electrical Impedance Myography (EIM) (optional)

Farmacocinética:
- Investigar la farmacocinética (FC) de dosis múltiples de RO6885247 y sus metabolitos, si procede.
- Obtener información preliminar sobre el efecto potencial de los alimentos sobre la farmacocinética de RO6885247.

Farmacodinámica:
- Investigar los efectos de farmacodinámica (FD) de RO6885247 de acuerdo con la evaluación de la modificación del proceso de corte de SMN2 y el aumento de la proteína SMN.
- Investigar la relación FC/FD de RO6885247 mediante modelos de FC/FD (FD para incluir ARNm del gen SMN2 y la proteína SMN).
- Investigar el efecto de 12 semanas de tratamiento con RO6885247 sobre la electrofisiología muscular según la evaluación del potencial de acción muscular compuesto (PAMC) (opcional para pacientes de 7 meses o menores).
- Investigar el efecto de 12 semanas de tratamiento con RO6885247 sobre la miografía de impedancia eléctrica (EIM).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Males and females aged below 7 months (inclusive) or 2 to 55 years (inclusive)
- Confirmed diagnosis of 5q-autosomal recessive SMA (Types 1 to 3). For patients aged 7 months or below, clinical symptoms attributable to type 1 SMA and two SMN2 copies.
- Able and willing to provide informed consent and to comply with the study protocol. Alternatively, a legally authorized representative must be able to consent for the patient and assent must be given by the patient wherever possible.
- Female patients of childbearing potential and male patients with a female partner of childbearing potential must agree with the required contraceptive methods as defined per protocol.

- Pacientes de ambos sexos, de entre 2 y 55 años (incluidos) o de hasta 7 meses de edad.
- Diagnóstico confirmado de AME autosómica recesiva ligada al cromosoma 5q. Para pacientes de hasta 7 meses de edad o menores, síntomas clínicos atribuibles a AME de tipo 1 y 2 copias del gen SMN2.
- Capaz y dispuesto a otorgar su consentimiento y cumplir el protocolo del estudio. Como alternativa, un representante legalmente autorizado debe dar su consentimiento en nombre del paciente y se debe dar el asentimiento por el paciente siempre que sea posible.
- Las mujeres en edad fértil y pacientes varones con pareja en edad fértil deben comprometerse deben comprometerse a utilizar métodos anticonceptivos tal y como se especifica en el protocolo.

E.4

Principal exclusion criteria

- Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening
- Concomitant or previous participation in a SMN2-targeting antisense oligonucleotide study within 12 months prior to screening
- Concomitant or previous participation at any time in a gene therapy study
- History of cell therapy
- Hospitalization for pulmonary event within the last 2 months or planned at the time of screening (for patients aged 2-55 years)
- Surgery for scoliosis in the last 6 months from screening or planned within 6 months from screening
- Unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease
- Clinically relevant ECG abnormalities at screening or baseline; personal or family history (first degree relatives) of congenital long QT syndrome
- Clinically significant abnormalities in laboratory test results at screening
- Any concomitant disease or condition that could interfere with the conduct of the study, or pose an unacceptable risk to the patient in this study
- Use of prohibited medications as per protocol within 90 days prior to randomization. Patients who are on inhaled corticosteroids, administered either through a nebulizer or an inhaler, are allowed.
- Recently initiated treatment (within <6 months prior to randomization) with oral salbutamol or another beta2-adrenergic agonist taken orally is not allowed. Patients who have been on oral salbutamol (or another beta2-adrenergic agonist) for at least 6 months before randomization are allowed. Use of inhaled beta2-adrenergic agonists is allowed.
- Ascertained or presumptive hypersensitivity (e.g. anaphylactic reaction) to RO6885247 or to the constituents of its formulation
- Patients aged 7 months or below requiring invasive ventilation, tracheotomy, day-time non-invasive ventilation or patients with nocturnal hypoxemia; patients having had severe pneumonia and have not fully recovered their pulmonary function at the time of screening; patients with contractures or hip subluxation/dislocation at birth; patients with non-SMA related morbidities.

- Participación simultánea o anterior en cualquier estudio de investigación sobre fármacos o dispositivos durante los 90 días anteriores a la selección.
- Participación simultánea o anterior en un estudio sobre oligonucleótidos antisentido dirigidos a SM/V2 durante los 12 meses anteriores a la selección.
- Participación simultánea o previa en cualquier fase de un estudio sobre terapia génica.
- Antecedentes de cualquier tipo de terapia celular.
- Hospitalización por episodio pulmonar durante los últimos 2 meses o prevista en el momento de la selección (para pacientes de 2 a 55 años).
- Cirugía de escoliosis realizada o planificada en los 6 meses posteriores a la selección.
- Enfermedad inestable en el sistema gastrointestinal, renal, hepático, cardiovascular o endocrino.
- Anomalías ECG de importancia clínica en el momento de la selección o en el momento basal; historial personal o familiar (familiares consanguíneos) de síndrome de QT largo congénito.
- Anomalías de importancia clínica en resultados de análisis durante selección.
- Cualquier tratamiento o enfermedad o trastorno concomitante que pudiera interferir en el desarrollo del estudio, o que pudiera suponer un riesgo inaceptable para el paciente en este estudio.
- Uso de medicamentes prohibidos por protocolo en los 90 días anteriores a la aleatorización. Se permitirá pacientes que tomen corticoesteroides inhalados, ya sea mediante nebulizador o inhalador.
- No se permiten tratamientos recientemente iniciados (dentro de los 6 meses anteriores a la aleatorización) con salbutamol oral u otro agonista ?2 adrenérgico administrado por vía oral. Se permitirá la participación de aquellos pacientes que hayan tomado salbutamol oral (u otro agonista ?2 adrenérgico) dentro de los 6 meses anteriores a la aleatorización. Se permite el uso de agonistas ?2 adrenérgicos inhalados (por ejemplo, para el tratamiento del asma).
- Hipersensibilidad demostrada o posible (por ejemplo, reacción anafiláctica) al RO6885247 o a los componentes de su formulación
- Para pacientes de hasta 7 meses de edad en el momento de la selección:
Pacientes que requieren ventilación invasiva o traqueostomía; ventilación no invasiva durante el día o que sufren hipoxemia nocturna (saturación de O2 < 93%); pacientes con neumonía grave que no han recuperado por completo su función pulmonar en el momento de la selección; pacientes con contracturas y/o dislocación o subluxación de cadera al nacer; pacientes con presencia de morbilidades no relacionadas con la AME.

E.5 End points

E.5.1

Primary end point(s)

Safety: Incidence of adverse events (AEs)

Seguridad:
Incidencia de acontecimientos adversos.

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 20 weeks

Hasta 20 semanas.

E.5.2

Secondary end point(s)

1. Pharmacokinetics: RO6885247 plasma concentrations
2. Pharmacokinetics: RO6885247 exposure, area under the concentration-time curve (AUC-tau, over the 24-hour dosing interval)
3. Pharmacodynamics: SMN protein levels in blood
4. Effect of RO6885247 on muscle electrophysiology, as assessed by Compound Muscle Action Potential (CMAP)
5. Effect of RO6885247 on Electrical Impedance Myography
6. Pharmacodynamics: In vivo splicing modification of SMN2 mRNA in blood

1. Farmacocinetica: vonventraciones en plasma de RO6885247 .
2 Farmacocinetica: RO6885247 AUCT (durante un intervalo de administración de 24 horas).
3. Farmacocinética: niveles de la proteína SMN en sangre.
4. Efecto de RO6885247 en la electrofisiología del músculo, evualuado por PAMC.
5. Efecto de RO6885247 en EIM.
6. Farmacocinética: Modificación de corte in vivo de ARNm del gen SMN2 en sangre.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Up to 16 weeks for patients aged 2-55 years-old; up to 20 weeks for patients aged 7 months or below (at screening)
2. Up to 12 weeks for patients aged 2-55 years-old; up to 20 weeks for patients aged 7 months or below (at screening)
3-6: Up to 20 weeks

1. Hasta 16 semanas para pacientes de - a 55 años de edad; hasta 20 semanas para pacientes de hasta 7 meses de edad (en selección).
2. Hasta 12 semanas para pacientes de 2 a 55 años de edad; hasta 20 semanas para pacientes de hasta 7 meses de edad (en selección).
3-6. Hasta 20 semanas.

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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, clinical genotyping

Tolerancia, genotipado clínico.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Ib, multiple dose study

Ib, estudio de dosis múltiple.

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

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

France

Italy

Netherlands

Spain

Sweden

Switzerland

Turkey

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

The date when the last patient?s last visit (LPLV) occurs

El estudio se considera finalizado con la última visita del último paciente (UVUP).

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:

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

children (see above)

Niños (ver más arriba)

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

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)

Should PD proof of mechanism on SMN2 mRNA be shown in this study and no safety concerns emerge, the Sponsor envisages providing access to RO6885247 to SMA patients enrolled in this study:
- without any treatment interruption for infant patients with type 1 SMA
- after the conclusion of this study and after completion of the nonclinical toxicology studies necessary to support chronic treatment in humans for patients aged 2-55 years.

Please refer to Protocol section 4.3.5 for further details.

Si se demostrara en este estudio el mecanismo de acción farmacodinámico de SMN2 mRNA y no surgieran problemas de seguridad, el promotor prevee proporcionar acceso a RO6885247 a pacientes con AME incluidos en este estudio:
Sin ninguna interrupción de tratamiento para pacientes infantiles con AME tipo 1.
Tras la finalización de este estudio y después de completarse los estudios no clínicos de toxicología necesarios para el apoyar el tratmiento crónico para pacientes entre 2-55 años.

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

2015-04-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-03-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-12-15

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