Clinical Trials Register

Summary
EudraCT Number:	2014-003330-12
Sponsor's Protocol Code Number:	EP0069
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:	2021-01-20
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

2014-003330-12

A.3

Full title of the trial

A double-blind, randomized, placebo-controlled study of the efficacy, safety/tolerability, and pharmacokinetic profile of UCB0942 in adult patients with highly drug-resistant focal epilepsy

Studio randomizzato, in doppio cieco, controllato con placebo, per valutare l'efficacia, la sicurezza/tollerabilità e il profilo farmacocinetico di UCB0942 in pazienti 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

A study of UCB0942 in adult patients with highly drug-resistant focal epilepsy

Studio su UCB0942 in pazienti adulti con epilessia focale altamente resistente ai farmaci

A.3.2

Name or abbreviated title of the trial where available

A study of UCB0942 in adult patients with highly drug-resistant focal epilepsy

Studio su UCB0942 in pazienti adulti con epilessia focale altamente resistente ai farmaci

A.4.1

Sponsor's protocol code number

EP0069

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.3.4	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.3.9.2	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	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.3.1	Product name	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.3.9.2	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	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	Film-coated tablet
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

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.1.2 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

The primary objective of the study is to evaluate the efficacy of UCB0942 administered concomitantly with each subject's current, stable antiepileptic drug (AED) regimen in subjects who have 4 or more focal seizures with or without secondary generalization per week and who have failed to achieve seizure control with =4 AED regimens of adequate dose and duration.In this protocol, unless otherwise specified,"focal seizures" refers to partial on set seizures of type IA1, IB and IC, but does not include type IA2,IA3,or IA4 seizures.

L'obiettivo primario dello studio è valutare l'efficacia di UCB0942 somministrato in concomitanza con il regime attuale,stabile di farmaco antiepilettico (AED) di ogni soggetto in soggetti che hanno 4 o più crisi epilettiche focali con o senza generalizzazione secondaria a settimana e che non sono riusciti a raggiungere il controllo delle crisi con = 4 regimi AED di dose e durata adeguata.In questo protocollo, se non diversamente specificato, "crisi epilettiche focali" si riferisce alle crisi parziali di tipo IA1, IB e IC, ma non include il tipo IA2, IA3, o crisi IA4 .

E.2.2

Secondary objectives of the trial

The secondary objectives are to evaluate the safety and tolerability of UCB0942 and to evaluate the steady-state PK of UCB0942 and its metabolites

Gli obiettivi secondari valutano la sicurezza e la tollerabilità di UCB0942 e lo stato stazionario di farmacocinetica (PK) di UCB0942 e dei suoi metaboliti.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

·Subject is an adult (18 years of age or more).
·Subject is able to understand the study and the ICF as assessed by the Investigator. Subjects with known mental retardation (defined as IQ below 70) are not eligible to participate.
·A written ICF approved by the or Independent Ethics Committee (IEC) 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. A separate ICF should be signed and dated by the subject to allow for the optional DNA, mRNA, and lipidomics/proteomics/additional blood biomarker samples.
·Subject and/or caregiver is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and the medication intake scheme as instructed according to the judgment of the Investigator.
·Subject is of normal weight as determined by a body mass index (BMI) between 16.0 and 40.0kg/m2 (exclusive) and with a body weight of at
least 50kg (males) or 45kg (females).
·Subject fulfills ILAE (1989) criteria for focal epilepsy: - clinical semiology should be described and fulfill criteria for focal seizures.
- there will have been an electroencephalogram (EEG) reading compatible with focal epilepsy in the last 5 years.
- the subject has no seizures that are not focal by the new ILAE criteria.
- a brain MRI (magnetic resonance imaging) or head CT (computed tomography) to be performed before randomization, if no such scan was performed in the last 5 years, and a report is available. If a scan was
performed within the last 5 years but the epilepsy has not been stable since the last scan, a new scan should be obtained.

• Il soggetto è un adulto (18 anni o più).
· Il soggetto è in grado di comprendere lo studio e l'ICF come valutato dallo sperimentatore.I soggetti con ritardo mentale noto(definito come QI inferiore a 70) non sono ammessi a partecipare.
· Un ICF scritto e approvato dal Comitato Etico Indipendente (IEC) è 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. Un ICF separato deve essere firmato e datato dal soggetto per consentire il prelievo di campioni opzionale per analisi DNA,mRNA,lipidomica/proteomica / o biomarkers supplementari nel sangue.
• Il soggetto è di peso normale come determinato da un indice di massa corporea (BMI)tra il 16,0 e 40.0kg / m2 (esclusiva), e con un peso corporeo di almeno 50kg (maschi) o 45kg (femmine).
•Soggetto soddisfa i criteri ILAE (1989) per l'epilessia focale:- La semiologia clinica dovrebbe essere descritta e soddisfiare i criteri di crisi epilettiche focali;-è stato effettuato un elettroencefalogramma (EEG) di lettura compatibile con epilessia focale negli ultimi 5 anni;-Il soggetto non ha crisi epilettiche che non sono focali secondo i nuovi criteri ILAE;- Un MRI al cervello (risonanza magnetica) o TC alla testa (tomografia computerizzata) da eseguire prima della randomizzazione, in mancanza di tale scansione negli ultimi 5 anni, una relazione deve essere disponibile. Se la scansione è stata effettuata nel corso degli ultimi 5 anni, ma l'epilessia non è rimasta stabile dopo l'ultima scansione, una nuova scansione dovrebbe essere ottenuta.

E.4

Principal exclusion criteria

·Subject has past or present substance abiuse/dependence that in the opinion of the investiagator could threaten the subject's safety within the study,affect the subject's ability to fully participate in the study,or confound study interpretation.·Subject has participated in another study of an investigational medication (or medical device) within the last 30 days or is currently participating in another study of an investigational medication (or a medical device).·Subject has either:>1.5x upper limit of normal (ULN) of any of the following:¿ alanine aminotransferase (ALT)¿ aspartate aminotransferase (AST)¿ alkaline phosphatase (ALP)-OR->ULN total bilirubin (=1.5xULN total bilirubin if known Gilbert's
syndrome).If subject has elevations only in total bilirubin that are >ULN and<1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's
syndrome (ie, direct bilirubin <35%).For randomized subjects with a baseline result >ULN for ALT, AST, ALP,or total bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful elevation
must be understood and recorded in the Case Report form (CRF).If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at
screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically
relevant increase, inclusion of the subject must be discussed with the Medical Monitor.·Subject has a known hypersensitivity to any components of UCB0942 formulation or to similar drugs (LEV, BRV, or benzodiazepines), or a history of drug or other allergy that, in the opinion of the Investigator or
UCB Study Physician, contraindicates her/his participation.·Subject has had significant blood loss or has donated or received 1 or more units (450mL) of blood within 30 days prior to UCB0942 administration, or has donated plasma or platelets within 14 days prior to UCB0942 administration for this study.·Subject tests positive for human immunodeficiency virus-1/2 antibody (HIV-1/2Ab), hepatitis B surface antigen (HBsAg), or hepatitis C
antibody (HCV-Ab).

Il soggetto ha un passato o presente di abuso/dipendenza da sostanze che, a giudizio dello sperimentatore potrebbe minacciare la sicurezza del soggetto all'interno dello studio, influenzare la capacità del soggetto a partecipare pienamente allo studio, o confondere l'interpretazione di studio.•Il pz ha partecipato a un altro studio di sperimentazione di farmaci(o dispositivi medici)negli ultimi 30 gg o sta attualmente partecipando a 1 altro studio su 1 farmaco sperimentale(o dispositivo medico).•il soggetto ha >1.5x sopra limite normale (ULN) di 1 dei seguenti:alanina aminotransferasi ALT,aspartatoaminotransferasi AST,fosfatasi alcalina ALP, O bilirubina tot >ULN (=1.5xULN bilirubina tot se sindorme Gisbert nota).se il soggetto ha rialzo solo in bilirubina tot che è >ULN e <1.5xULN,bilirubina frazionata per identificare possibile sindrome di Gilbert non diagnosticata(es.bilirubina diretta <35%).per pz randomizzati con risultato basale >ULN per ALT,AST,ALP o bilirubina tot,1 diagnosi basale e/o la causa di ogni rialzo clinicamente significativo dev'essere compresa e registrata in CRF.se pz ha >ULN ALT,AST o ALP allo screening che non corrisponde al limite di esclusione,ripetere i tests,se possibile,prima della dose per assicurare che non ci siano ulteriori aumenti clinicamente rilevanti.in caso di aumenti clinicamente rilevanti,l'inclusione di pz dev'essere discussa con il medical monitor.· Il soggetto ha una nota ipersensibilità a qualsiasi componente della formulazione di UCB0942 o a farmaci simili (LEV, BRV, o benzodiazepine), o una storia di droga o altre allergie che, secondo il parere del ricercatore o Medici di UCB, controindicano la sua partecipazione.Il soggetto ha avuto una significativa perdita di sangue o ha donato o ricevuto 1 o più unità (450ml) di sangue entro 30 giorni prima della somministrazione di UCB0942, o ha donato plasma o piastrine entro 14 giorni prima della somministrazione di UCB0942 per questo studio.
Il soggetto è positivo per gli anticorpi del virus dell'immunodeficienza umana-1/2 (HIV-1 / 2ab), antigeni di superficie dell'epatite B (HBsAg), o anticorpi per epatite C (HCV-Ab).

E.5 End points

E.5.1

Primary end point(s)

75 % responder rate (75 % RR, proportion of subjects who achieve =75 % reduction in focal seizure frequency)

tasso di risposta del 75% (75%RR: percentuale di soggetti con una riduzione del 75% o più nella frequenza delle crisi focali)

E.5.1.1

Timepoint(s) of evaluation of this end point

During 2 weeks of the Inpatient Period

durante le 2 settimane del periodo di ricovero

E.5.2

Secondary end point(s)

• Median percent reduction in weekly focal seizure frequency , during 2-weeks of the Inpatient Period
• Median percent reduction in weekly focal seizure frequency , during the UCB0942 overall period (approximately 11 weeks)
• 75 % responder rate (75 % RR, proportion of subjects who achieve =75 % reduction in focal seizure frequency) during the last 4 weeks of the
Outpatient Maintenance Period
• Seizure-free rate during the 2-week Inpatient Period, during 2 weeks of the Inpatient Period
• Seizure-free rate during the last 4 weeks of the Outpatient Maintenance Period
• Seizure-free rate during the UCB0942 Overall period during UCB0942 Overall period (approximately 11 weeks)
• Percentage of seizure free days during the 2-week Inpatient Period, 2 weeks of the Inpatient Period
• Percentage of seizure free days during the Outpatient Maintenance Period, during the Outpatient Maintenance Period (approximately 8
weeks)
• Number of patients reporting at least one Adverse Event (AE) during the course of the study, all study duration (approximately 19 to 20 weeks)
• Number of patients reporting at least one at least one Serious Adverse Event (SAE) during the course of the study, all study duration (approximately 19 to 20 weeks)
• Number of subject withdrawals due to Adverse Events (AEs) during the course of the study, all study duration (approximately 19 to 20 weeks)

• riduzione percentuale mediana nella frequenza delle crisi focali settimanali, durante 2 settimane del periodo di ricovero
• riduzione percentuale mediana nella frequenza delle crisi focali settimanali, durante tutto il periodo con UCB0942 (circa 11 settimane)
• tasso del 75% di responder (75% RR, proporzione di soggetti che raggiungono la riduzione =75% della frequenza delle crisi focali) durante le ultime 4 settimane ddel periodo di mantenimento ambulatoriale
• tasso libero da crisi durante le 2 settimane di degenza, per 2 settimane del periodo di degenza
• tasso privo di crisi nel corso delle ultime 4 settimane del periodo di mantenimento ambulatoriale
• tasso privo di crisi durante il periodo con UCB0942 complessivo (circa 11 settimane)
• Percentuale di giorni liberi da crisi durante le 2 settimane di degenza, Periodo, 2 settimane del periodo di degenza
• Percentuale di giorni liberi da crisi durante il Periodo di Mantenimento ambulatoriale,(circa 8
settimane)
• Numero di pazienti con almeno un evento avverso (AE) nel corso dello studio, tutta la durata dello studio (circa da 19 a 20 settimane)
• Numero di pazienti con almeno un evento avverso grave (SAE) durante il corso dello studio, tutta la durata dello studio (circa da 19 a 20 settimane)
• Numero di prelievi ai soggetti a causa di eventi avversi (AE) nel corso dello studio, tutta durata dello studio (circa da 19 a 20 settimane)

E.5.2.1

Timepoint(s) of evaluation of this end point

During the complete study at different time points as defined in field Secondary End Point.

Durante lo studio completo in momenti diversi, come definito nel campo End Point secondario.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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

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

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

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)

Subjects who experience substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator may have the opportunity to continue taking UCB0942 in an open-label extension (OLE) study. Subjects who enter the OLE study will not have a Tapering Period at the end of the Outpatient Period. The OLE study is described in a separate protocol with number EP0073.

I soggetti che mostrano notevoli benefici da UCB0942 con tollerabilità accettabile in base al soggetto e allo sperimentatore possono avere l'opportunità di continuare a prendere UCB0942 in uno studio di estensione in aperto (OLE) studio. I soggetti che entrano nello studio OLE non avranno un periodo di tapering alla fine del Periodo ambulatoriale. Lo studio OLE è descritto in un protocollo separato con il numero EP0073.

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

2016-03-18

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
P.	Date of the global end of the trial	2017-07-18

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Clinical trials