Clinical Trials Register

Summary
EudraCT Number:	2013-001025-53
Sponsor's Protocol Code Number:	109MS405
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-03-03
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

2013-001025-53

A.3

Full title of the trial

A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsule (TECNERGY)

Estudio abierto multicéntrico para evaluar el cansancio en sujetos con esclerosis múltiple recidivante-remitente durante el tratamiento con Tecfidera® (dimetil fumarato) en cápsulas duras gastrorresistentes (TECNERGY)

A.3.1

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

A Study that evaluates Fatigue in Multiple Sclerosis Patients taking Tecfidera® (Dimethyl Fumarate)

Un estudio que evalúa la fatiga en pacientes con esclerosis múltiple que están tomandoTecfidera® (dimetil fumarato)

A.3.2

Name or abbreviated title of the trial where available

TECNERGY

A.4.1

Sponsor's protocol code number

109MS405

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	Biogen Idec Research Limited
B.1.3.4	Country	United Kingdom
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	Biogen Idec Research Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Biogen Idec Research Limited
B.5.2	Functional name of contact point	Pedro Allende Echevarrieta
B.5.3	Address:
B.5.3.1	Street Address	Innovation House, 70 Norden Road
B.5.3.2	Town/ city	Maidenhead
B.5.3.3	Post code	SL6 4AY
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+3491702 79 63
B.5.6	E-mail	pedro.allendeechevarrieta@biogenidec.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	Tecfidera (BG00012)
D.2.1.1.2	Name of the Marketing Authorisation holder	Biogen Idec Limited
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Tecfidera
D.3.2	Product code	BG00012
D.3.4	Pharmaceutical form	Gastro-resistant capsule, hard
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	DIMETHYL FUMARATE
D.3.9.1	CAS number	624-49-7
D.3.9.2	Current sponsor code	BG00012
D.3.9.3	Other descriptive name	DIMETHYL FUMARATE
D.3.9.4	EV Substance Code	SUB13608MIG
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	240
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	Tecfidera (BG00012)
D.2.1.1.2	Name of the Marketing Authorisation holder	Biogen Idec Limited
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Tecfidera
D.3.2	Product code	BG00012
D.3.4	Pharmaceutical form	Gastro-resistant capsule, hard
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	DIMETHYL FUMARATE
D.3.9.1	CAS number	624-49-7
D.3.9.2	Current sponsor code	BG00012
D.3.9.3	Other descriptive name	DIMETHYL FUMARATE
D.3.9.4	EV Substance Code	SUB13608MIG
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	120
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

Relapsing-Remitting Multiple Sclerosis

Esclerosis múltiple recidivante-remitente

E.1.1.1

Medical condition in easily understood language

Multiple Sclerosis

Esclerosis múltiple

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	17.1
E.1.2	Level	SOC
E.1.2	Classification code	10029205
E.1.2	Term	Nervous system disorders
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10063399
E.1.2	Term	Relapsing-remitting multiple sclerosis
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to determine whether DMF taken over 12 months is effective in reducing MS related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in subjects with RRMS.

El objetivo principal del estudio es determinar si el tratamiento con DMF durante 12 meses disminuye eficazmente el cansancio asociado a la EM, determinado mediante la variación media en la Escala de cansancio para las funciones motoras y cognitivas (FSMC), en pacientes con EMRR.

E.2.2

Secondary objectives of the trial

To investigate changes from Baseline in FSMC and fatigue severity (Fatigue Severity Scale [FSS]) at 1, 3, 6, 9, and 12 months in subjects receiving DMF

To assess the impact of DMF on patient reported outcomes (PROs), including work productivity (Work Productivity and Activity Impairment-Multiple Sclerosis questionnaire [WPAI-MS]), health-related quality of life (Short Form Health Survey [SF-12] or the 15-dimensional health-related quality of life [15D HRQoL] questionnaire), depression (Beck Depression Inventory-Fast Screen [BDI-FS]), and sleepiness (Epworth Sleepiness Scale [ESS]) at 6 and 12 months in subjects receiving DMF

To examine whether an association exists between fatigue and baseline demographics (e.g., age and sex) and disease characteristics (e.g., disease duration, baseline disease activity, treatment history, expanded disability status scale [EDSS] score, and PROs)

To assess any changes in fatigue-related medication use

Investigar la variación de la FSMC y de la intensidad del cansancio (Escala FSS) entre el momento basal y los meses 1, 3, 6, 9 y 12 de tratamiento con DMF.
Evaluar el efecto del tratamiento con DMF sobre los resultados comunicados por los pacientes (RCP) acerca de la productividad laboral (Cuestionario WPAI-MS), la calidad de vida relacionada con la salud (Cuestionario SF-12 o Cuestionario 15D HRQoL), la depresión (Escala de depresión de Beck - evaluación rápida [BDI-FS]) y la somnolencia (Escala de somnolencia de Epworth [ESS]) a los 6 y 12 meses de tratamiento con DMF.
Analizar si existe relación entre el cansancio, los datos demográficos (por ejemplo, sexo, edad) y las características clínicas basales (por ejemplo, duración de la enfermedad, actividad de la enfermedad en el momento basal, tratamientos previos, puntuación en la Escala ampliada del estado de discapacidad [EDSS] y RCP).
Evaluar todos los cambios efectuados en la medicación para el cansancio.

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

Biomarker Sub-Study. Subjects who consent to participate will provide blood samples that will be used to identify or verify deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and serum markers associated with disease and response to DMF.

Subestudio de análisis de biomarcadores. Los sujetos que acceden a participar proporcionarán muestras de sangre que se utilizarán para identificar o verificar en las muestras la presencia de ácido desoxirribonucleico (ADN), ácido ribonucleico (ARN), y los marcadores séricos de la enfermedad y su respuesta al DMF.

E.3

Principal inclusion criteria

Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.

Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.

Have a stable EDSS (as assessed by the Investigator) and have been on the same (type and dosage) standard of care first line treatment for at least 6 months.

If taking antidepressants, amphetamine, modafinil, or fampridine (Fampyra), subject must be assessed as having been clinically stable for at least 3 months prior to the Baseline Visit.

Age >= 18 years at the time of informed consent.

FSMC total score >= 43 (mild fatigue) at Baseline.

As perceived by the Investigator, have the ability to comply with all requirements of the study protocol.

Female subjects of childbearing potential who are not surgically sterile must practice effective contraception during their participation in the study and be willing and able to continue contraception for 12 weeks after their last dose of study treatment.

Tener la capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado por escrito, firmando y fechando el documento correspondiente, así como de autorizar la utilización de información sanitaria confidencial conforme a la legislación nacional y local de confidencialidad de los datos del paciente.

Tener un diagnóstico confirmado de EMRR y cumplir la indicación terapéutica que se indica en la ficha técnica local.

Presentar una EMRR estable (conforme a lo determinado por el investigador) y haber recibido el mismo tratamiento de primera línea de referencia (tipo y dosis) durante los últimos seis meses.

En caso de recibir tratamiento con antidepresivos, anfetamina, modafinilo o fampridina (Fampyra), el paciente deberá haber permanecido clínicamente estable desde al menos tres meses antes de la visita basal.

Edad >= 18 años en el momento del consentimiento informado.

Puntuación total en la FSMC >= 43 (cansancio leve) en el momento basal.

Ser capaz, en opinión del investigador, de cumplir todos los requisitos del protocolo del estudio.

Las pacientes en edad fértil que no se hayan sometido a esterilización quirúrgica deberán utilizar métodos anticonceptivos eficaces durante su participación en el estudio y estar dispuestas a mantenerlos, y ser capaces de hacerlo, hasta 12 semanas después de la última dosis de tratamiento del estudio.

E.4

Principal exclusion criteria

Diagnosis of major depression, as identified by the Investigator.

Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS.

History of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.

History of a relapse within 90 days prior to study enrollment or showing transient symptoms derived from a previous relapse, irrespective of time of symptom onset.

Treatment of MS relapse within 90 days prior to study enrollment.

History of a positive test result for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody.

Female subjects who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding.

Impaired hepatic or renal function, as perceived by the Investigator.

Any prior treatment with DMF (or other fumarate derivative), total lymphoid irradiation, cladribine, fingolimod, T cell or T-cell receptor vaccination, or any therapeutic monoclonal antibody.

Treatment within 1 year prior to study enrollment with mitoxantrone or cyclophosphamide.

Treatment within 6 months prior to study enrollment with cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, intravenous immunoglobulin, plasmapheresis, cytapheresis, or another investigational drug or approved therapy for investigational use.

Current enrollment in any other clinical studies.

Known to suffer from narcolepsy or another significant sleep disorder.

Comorbidity that may have an impact on fatigue.

Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

Diagnóstico de depresión mayor identificado por el investigador.

Diagnóstico de EM progresiva primaria, progresiva secundaria o progresiva recidivante.

Antecedentes de neoplasia maligna (excepto el carcinoma basocelular extirpado por completo antes de la inclusión en el estudio), reacciones alérgicas graves o anafilácticas o hipersensibilidad a fármacos, anomalías analíticas indicativas de una enfermedad importante o enfermedad importante que impida la participación en un ensayo clínico.

Antecedentes de recidiva en los 90 días precedentes a la inclusión en el estudio o presencia de síntomas transitorios debidos a una recidiva previa, con independencia del momento en que apareció el síntoma.

Haber recibido tratamiento para una recidiva de la EM en los 90 días precedentes a la inclusión en el estudio.

Antecedentes de resultado positivo en la prueba del virus de la inmunodeficiencia humana, del anticuerpo del virus de la hepatitis C o del virus de la hepatitis B (definida como positividad para el antígeno de superficie o para el anticuerpo nuclear del virus de la hepatitis B).

Mujeres embarazadas o que tengan previsto quedarse embarazadas durante el estudio, o que estén en período de lactancia.

Trastorno de la función hepática o renal, a criterio del investigador.

Antecedentes de tratamiento con DMF (u otro derivado del fumarato), irradiación linfática total, cladribina, fingolimod, vacunas de linfocitos T o de receptores de linfocitos T o cualquier anticuerpo monoclonal terapéutico.

Tratamiento con mitoxantrona o ciclofosfamida durante el último año antes de la inclusión en el estudio.

Tratamiento con ciclosporina, azatioprina, metotrexato, micofenotalo mofetilo, inmunoglobulinas intravenosas, plasmaféresis, citaféresis, otro fármaco experimental u otro tratamiento aprobado para uso experimental en los seis meses previos a la inclusión en el estudio.

Participación actual en otros estudios clínicos.

Narcolepsia o cualquier otro trastorno importante del sueño.

Enfermedades concomitantes que afecten al cansancio.

Otro motivo no especificado que, en opinión del investigador o de Biogen Idec, impida la inclusión del paciente.

E.5 End points

E.5.1

Primary end point(s)

Mean change from Baseline in MS-related fatigue (FSMC) at 12 months in subjects receiving DMF.

Variación media del cansancio asociado a la EM (FSMC) entre el momento basal y el mes 12 de tratamiento con DMF.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 meses

E.5.2

Secondary end point(s)

Mean change from Baseline in fatigue (FSMC and FSS) at 1, 3, 6, 9, and 12 months in subjects receiving DMF

Mean change from Baseline in work productivity, quality of life, depression, and sleepiness at 6 and 12 months in subjects receiving DMF

Change in MS-related fatigue (FSMC) status (improved [> 4.5 increase], stable [within ±4.5], and worsened [> 4.5 decrease])

Correlation of fatigue with baseline demographics and disease characteristics

Proportion of subjects with reduced dose or discontinuation of fatigue related medications at 6 and 12 months

Variación media del cansancio (FSMC y FSS) entre el momento basal y los meses 1, 3, 6, 9 y 12 de tratamiento con DMF.

Variación media de la productividad laboral, la calidad de vida, la depresión y la somnolencia entre el momento basal y los meses 6 y 12 de tratamiento con DMF.

Variación del estado de cansancio asociado a la EM (FSMC) (mejoría [aumento > 4,5], estabilización [variación de ± 4,5] o empeoramiento [disminución > 4,5]).

Correlación entre el cansancio y las características demográficas y clínicas basales.

Porcentaje de pacientes a los que se ha reducido o retirado la medicación para el cansancio a los 6 y 12 meses.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

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

LVLS: The end of study is last subject, last visit for final collection of data for the primary outcome.

La última visita del último paciente: El fin del estudio es el úlltimo paciente, la última visita de la última recogida de datos para el resultado primario.

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:

320

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

320

F.4.2.2

In the whole clinical trial

320

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)

There are no post trial treatment plans. DMF will not be made available to subjects after the end of the study under this protocol.

No hay planes de tratamiento después del ensayo. DMF no se pondrá a disposición de los sujetos después del final del estudio.

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

2015-05-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-09

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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