Clinical Trials Register

Summary
EudraCT Number:	2015-001268-20
Sponsor's Protocol Code Number:	EP0073
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-04
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-001268-20

A.3

Full title of the trial

AN OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF UCB0942 WHEN USED AS ADJUNCTIVE THERAPY FOR PARTIAL-ONSET SEIZURES IN ADULT
SUBJECTS WITH HIGHLY DRUG-RESISTANT FOCAL EPILEPSY

STUDIO DI ESTENSIONE IN APERTO, MULTICENTRICO, PER VALUTARE LA SICUREZZA, LA TOLLERABILITÀ E L'EFFICACIA A LUNGO TERMINE DI UCB0942 QUANDO UTILIZZATO COME TERAPIA AGGIUNTIVA PER CRISI PARZIALI IN SOGGETTI ADULTI CON EPILESSIA FOCALE ALTAMENTE RESISTENTE AI FARMACI

A.3.1

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

An open-label extension study of UCB0942 in adult patients with highly drug-resistant focal epilepsy.

STUDIO DI ESTENSIONE IN APERTO SU UCB0942 IN SOGGETTI ADULTI CON EPILESSIA FOCALE ALTAMENTE RESISTENTE AI FARMACI

A.3.2

Name or abbreviated title of the trial where available

An open-label extension study of UCB0942 in adult patients with highly drug-resistant focal epilepsy

STUDIO DI ESTENSIONE IN APERTO SU UCB0942 IN SOGGETTI ADULTI CON EPILESSIA FOCALE ALTAMENTE RESISTEN

A.4.1

Sponsor's protocol code number

EP0073

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	UCB Biopharma SRL
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	UCB Biopharma SPRL
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	UCB BIOSCIENCES GmbH
B.5.2	Functional name of contact point	CT Registries & Results Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Alfred-Nobel-Strasse 10
B.5.3.2	Town/ city	Monheim
B.5.3.3	Post code	40789
B.5.3.4	Country	Germany
B.5.4	Telephone number	00492173481515
B.5.5	Fax number	00492173481572
B.5.6	E-mail	clinicaltrials@ucb.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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.3.1	Product name	UCB0942
D.3.2	Product code	[UCB0942]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1294000-61-5
D.3.9.2	Current sponsor code	UCB0942
D.3.9.4	EV Substance Code	SUB33843
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.3.1	Product name	UCB0942
D.3.2	Product code	[UCB0942]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1294000-61-5
D.3.9.2	Current sponsor code	UCB0942
D.3.9.4	EV Substance Code	SUB33843
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	100
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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.3.1	Product name	UCB0942
D.3.2	Product code	[UCB0942]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1294000-61-5
D.3.9.2	Current sponsor code	UCB0942
D.3.9.4	EV Substance Code	SUB33843
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

highly drug-resistant focal epilepsy

EPILESSIA FOCALE ALTAMENTE RESISTENTE AI FARMACI

E.1.1.1

Medical condition in easily understood language

highly drug-resistant focal epilepsy

EPILESSIA FOCALE ALTAMENTE RESISTENTE AI FARMACI

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10065337
E.1.2	Term	Focal epilepsy
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the long-term safety and tolerability of UCB0942 at individualized doses between 100mg/day to a maximum of 800mg/day in subjects with highly drug-resistant focal epilepsy.

Valutare la sicurezza e la tollerabilità a lungo termine di UCB0942 a dosi individualizzate comprese tra 100 mg/giorno fino a un massimo di 800 mg/giorno in soggetti con epilessia focale altamente resistente ai farmaci.

E.2.2

Secondary objectives of the trial

• To evaluate the long-term efficacy of UCB0942
• To evaluate the effects of UCB0942 on the subject’s quality of life.

- Valutare l'efficacia a lungo termine di UCB0942.
- Valutare gli effetti di UCB0942 sulla qualità della vita dei soggetti.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study
• Subject must have completed V13 of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073
• In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject
• In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator
• No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator
• Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods.
• Male subject confirms that, during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom) AND that the respective partner will use an additional contraceptive method

• Un modulo di consenso informato scritto approvato dal Comitato Etico Indipendente è stato firmato e datato dal soggetto, dopo che lo sperimentatore abbia valutato se il soggetto è in grado di comprendere i potenziali rischi e benefici della partecipazione allo studio
•Il soggetto deve aver completato V13 del periodo di mantenimento ambulatoriale di EP0069 per poter essere eleggibile all'arruolamento per EP0073
• In EP0069, il soggetto ha dimostrato una riduzione della frequenza e/o la gravità delle crisi rispetto al basale che è considerato clinicamente significativo dallo sperimentatore e significativo da parte del soggetto
• In EP0069, il soggetto sperimenta sostanziale beneficio da UCB0942 con tollerabilità accettabile in accordo al soggetto e sperimentatore
• Nessun problema di tollerabilità che può prevalere sui benefici raggiunti, secondo il parere del ricercatore
• soggetti di sesso femminile non fertili (premenarca, postmenopausa da almeno 2 anni, ovariectomia bilaterale o legatura delle tube, e completa isterectomia) sono ammissibili. Soggetti di sesso femminile in età fertile sono ammissibili quando utilizzano metodi contraccettivi medicalmente accettati
• soggetti maschili devono confermare che, durante il periodo di studio e per un periodo di 3 mesi dopo l'ultima dose, quando avranno rapporti sessuali con una donna in età fertile, useranno un contraccettivo di barriera (per esempio, preservativo) e che il rispettivo partner utilizzerà un metodo contraccettivo addizionale

E.4

Principal exclusion criteria

• Subject has active suicidal ideation as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the “Since Last Visit” version of the Columbia Suicide Severity Rating Scale. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study
• Subject has taken other (non-Anti-Epileptic Drug) prescription, non-prescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half lives whichever is longer) prior to study entry
• Subject has an abnormality in the 12-lead electrocardiography that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any subject with any of the following findings will be excluded:
- Prolonged QTc (Bazett’s, machine-read) interval defined as > 450 ms for males and > 470 ms for females
- Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval = 220 ms)
- Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
- In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration
• Subject has a clinically significant abnormality on echocardiography at the Entry Visit (V2) of EP0073

• Il soggetto presenta idee suicide attive, come indicato da una risposta positiva ("Sì") a Domanda 4 o Domanda 5 della versione "dall'ultima visita" del CSSRS. Il soggetto deve essere affidata immediatamente ad un professionista sanitario mentale e deve essere ritirato dallo studio
• Il soggetto ha assunto altre (farmaco anti antiepilettico) prescrizioni, non soggetti a prescrizione, alimentari (ad esempio, pompelmo o frutto della passione), o prodotti a base di erbe che sono induttori o inibitori potenti del pathway di CYP3A4 per 2 settimane (o 5 emivite a seconda di quale è più lungo) prima dell'ingresso nello studio
• Il soggetto presenta un'anomalia nell'elettrocardiografia a 12 derivazioni che, a giudizio dello sperimentatore, aumenta i rischi associati alla partecipazione allo studio. Inoltre, qualsiasi soggetto con qualsiasi delle seguenti caratteristiche saranno esclusi:
- Prolungato QTc (lettura su macchina di Bazett) Intervallo definito come> 450 ms per i maschi e> 470 ms per le femmine
- blocchi di branca e altre anomalie della conduzione diversi da blocco atrioventricolare di primo grado (definita come intervallo PR = 220 ms)
- Ritmi irregolari diversi da aritmia sinusale o occasionale, battiti ectopico rari ventricolari o sopraventricolari
- A giudizio dello Sperimentatore, configurazioni dell'onda T non sono di qualità sufficiente per valutare la durata dell'intervallo QT
• Il soggetto presenta un'anomalia clinicamente significativo sulla Ecocardiografia alla visita di ingresso (V2) di EP0073

E.5 End points

E.5.1

Primary end point(s)

• The 75% Responder Rate at the end of
the Evaluation Period
• Percentage of subjects with at least one treatment-emergent Adverse Events during the EP0073 study
• Percentage Number of subjects with at least one Serious Adverse Event during the EP0073 study
• Percentage of subjects discontinued due to treatment-emergent Adverse Events during the EP0073 study

• tasso di responder del 75% alla fine del periodo di valutazione.
• Percentuale di soggetti con almeno un trattamento da evento avverso durante lo studio EP0073
• Percentuale di soggetti con almeno un evento avverso serio durante lo studio EP0073
• Percentuale di soggetti che hanno interrotto lo studio a causa di un trattamento da evento avverso durante lo studio EP0073

E.5.1.1

Timepoint(s) of evaluation of this end point

58 months

58 mesi

E.5.2

Secondary end point(s)

• Median partial-onset seizure frequency per 28 days over the Evaluation Period of the EP0073 study
• Median partial-onset seizure frequency per 28 days by seizure type over the Evaluation Period of the EP0073 study
• Percent reduction in partial-onset seizure frequency relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069 over the Evaluation Period of the EP0073 study
• The 50 % responder rate over the Evaluation Period of the EP0073 study
• Percentage of seizure-free days over the Evaluation Period
• Seizure-free rate over the Evaluation Period
• Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) scores from Visit 3 (Week 2) of EP0069 through the assessment of the Evaluation
Period

• frequenza mediana delle crisi a esordio parziale per 28 giorni durante il periodo di valutazione
dello studio EP0073
• frequenza mediana delle crisi a esordio parziale per 28 giorni dal tipo di crisi nel corso del Periodo di valutazione dello studio EP0073
• frequenza di riduzione percentuale a esordio parziale delle crisi rispetto al periodo prospettico di 2 settimane ambulatoriale definito in EP0069 nel corso del periodo di valutazione dello studio EP0073
• Il tasso di responder del 50% rispetto al periodo di valutazione dello studio EP0073
• Percentuale di giorni liberi da crisi nel corso del Periodo di valutazione
• tasso privo di crisi nel corso del Periodo di valutazione
• Le variazioni di qualità della vita nel punteggio QOLIE-31-P da visita 3 (Settimana 2) di EP0069 attraverso la valutazione
del periodo di valutazione

E.5.2.1

Timepoint(s) of evaluation of this end point

58 months

58 mesi

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

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

Yes

E.8.1.7.1

Other trial design description

In aperto

Open

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

Information not present in EudraCT

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:

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

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None.

nessuno

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

2016-04-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-16

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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