Clinical Trials Register

Summary
EudraCT Number:	2010-021238-74
Sponsor's Protocol Code Number:	SP0994
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:	2011-12-27
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

2010-021238-74

A.3

Full title of the trial

A MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, FOLLOW UP STUDY EVALUATING THE LONG TERM SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) IN COMPARISON WITH CARBAMAZEPINE (400 TO 1200MG/DAY), USED AS MONOTHERAPY IN SUBJECTS WITH PARTIAL ONSET OR GENERALIZED TONIC CLONIC SEIZURES ≥16 YEARS OF AGE COMING FROM THE SP0993 STUDY

Studio multicentrico, di follow-up, in doppio cieco e double-dummy, per valutare la sicurezza a lungo termine di lacosamide (da 200 a 600 mg/die) rispetto a carbamazepina (da 400 a 1200 mg/die), somministrate in monoterapia, in soggetti di eta' >= 16 anni affetti da crisi epilettiche parziali o tonico-cloniche generalizzate provenienti dallo studio SP0993

A.3.1

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

Study investigating lacosamide- already approved by the European Medicines Agency as add on therapy for the treatment of partial-onset seizures in a new indication- in patients epilepsy and experiencing partial-onset or generalized tonic-clonic seizures. Study has two groups: One group of patients will be treated with lacosamide + placebo and a second one with carbamazepine + placebo. Neither the patient nor the doctor will know the treatm

Lo studio investiga gli effetti del lacosamide in una nuova indicazione in pazienti affetti da crisi epilettiche parziali o tonico-cloniche generalizzate. Lo studio comprende 2 gruppi dicui 1 trattato con lacosamide + placebo e l con carbamazepina+placebo. Ne' ilpaziente ne' il medico conosceranno il gruppo di trattamento.Solo per i pazienti dello studio SP0993.

A.4.1

Sponsor's protocol code number

SP0994

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 BIOSCIENCES GMBH
B.1.3.4	Country	Germany
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 BIOSCIENCES GMBH
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Edev S.a'.r.l.
B.4.2	Country	Luxembourg
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	-
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	+49 2173 48 1095
B.5.5	Fax number	+49 2173 48 1572
B.5.6	E-mail	Maria-Luise.Esch@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	Yes
D.2.1.1.1	Trade name	Vimpat
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma S.A
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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.3.4	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.3.8	INN - Proposed INN	LACOSAMIDE
D.3.9.1	CAS number	175481-36-4
D.3.9.2	Current sponsor code	SPM927
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	50
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	Comparator
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	Tegretol Retard
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Pharmaceuticals UK Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Prolonged-release 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	298-46-4
D.3.9.3	Other descriptive name	CARBAMAZEPINE
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: 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	Yes
D.2.1.1.1	Trade name	Vimpat
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma S.A
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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.3.4	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.3.8	INN - Proposed INN	LACOSAMIDE
D.3.9.1	CAS number	175481-36-4
D.3.9.2	Current sponsor code	SPM927
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
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

Epilepsy; partial onset or generalized tonic clonic seizures

Epilessia;crisi epilettiche parziali o tonico-cloniche generalizzate

E.1.1.1

Medical condition in easily understood language

Epilepsy

Epilessia

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10015037
E.1.2	Term	Epilepsy
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 objectives of this study are: • To obtain information about the long term safety of Lacosamide (LCM) in comparison with Carbamazepine Controlled Release (CBZ CR) when used as monotherapy in subjects with recently diagnosed partial onset or generalized tonic clonic seizures • To allow subjects who completed the monotherapy study SP0993 to continue to receive LCM or CBZ CR

L’obiettivo dello studio è_ - ottenere informazioni in merito alla sicurezza a lungo termine della lacosamide (LCM) rispetto alla carbamazepina a rilascio controllato (CBZ-CR), somministrate in monoterapia, in pazienti con diagnosi recente di crisi epilettiche parziali o tonico-cloniche generalizzate;- consentire ai pazienti che abbiano completato lo studio in monoterapia SP0993 di continuare ad assumere LCM o CBZ-CR.

E.2.2

Secondary objectives of the trial

4.1.2 Other safety variables The other safety variables are as follows: • Changes in hematology, chemistry, and urinalysis parameters • Changes in 12-lead electrocardiograms (ECGs) • Changes in vital sign measurements (ie, blood pressure [BP] and pulse rate) • Changes in physical or neurological examination findings • Changes in body weight 4.2. Exploratory variables 4.2.1 Efficacy variables Efficacy evaluations will be based on subject diaries where types, dates, and number of seizures are recorded. The exploratory efficacy variables are: • Percentage of subjects seizure free • Retention rate (ie, duration of treatment in the study)

Prot.sez.4.1.2 Altre variabili di sicurezza sono: • Variazione dei parametri ematologici, chimici e urinari • Variazione dell’elettrocardiogramma a 12 derivazioni (ECG) • Variazione dei parametri vitali (pressione e frequenza del polso) • Variazione dei risultati dell’esame obiettivo o neurologico • Variazione del peso.Prot.sez.4.2 La valutazione dell’efficacia si baserà sui diari dei pazienti, nei quali saranno registrati tipo, data e numero di crisi. Le variabili esplorative di efficacia sono:• Percentuale di pazienti liberi da crisi;• Tasso di ritenzione in trattamento (cioè, durata del trattamento durante lo studio).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors. 2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator. 3. Subject has remained seizure free and completed the Maintenance Phase of the SP0993 monotherapy study; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase. 4. Subject is expected to benefit from participation in SP0994 in the opinion of the investigator.

1. Il paziente, un genitore o un rappresentante legale dovranno firmare e datare un modulo per il consenso informato scritto approvato dalla Commissione di revisione dell’Istituzione (IRB)/Comitato Etico indipendente (IEC). Ove previsto, anche i pazienti minorenni firmeranno e dateranno un modulo per il consenso informato o un modulo speciale di assenso. 2. Lo sperimentatore dovrà ritenere che il paziente/rappresentante legale sia affidabile e capace di rispettare il protocollo (per es., in grado di capire e di compilare i diari), il programma di visite e l’assunzione del farmaco. 3. Il paziente dovrà essere libero da crisi durante la Fase di mantenimento dello studio SP0993 in monoterapia e dovrà aver completato tale fase, oppure dovrà essere incorso in 1 o più episodi di crisi epilettiche in concomitanza con la prima o la seconda dose target durante la Fase di mantenimento dello studio SP0993. 4. Lo sperimentatore dovrà ritenere che il paziente possa trarre un beneficio dalla partecipazione allo studio SP0994.

E.4

Principal exclusion criteria

1. Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM) or Cabamazepine Controlled Release (CBZ CR). 2. Subject experienced a seizure at the third target dose (ie, LCM 600mg/day or CBZ CR 1200mg/day) during the Evaluation Phase or Maintenance Phase of the SP0993 study. 3. Subject is taking benzodiazepines for a nonepilepsy indication. 4. Subject meets a withdrawal criterion for the previous study SP0993. 5. Subject is experiencing an ongoing SAE from the previous study SP0993.

1. Pazienti che assumono altri farmaci sperimentali oltre alla LCM o alla CBZ-CR o utilizzano dispositivi medici sperimentali. 2. Pazienti nei quali si sia manifestata una crisi in concomitanza con la terza dose target (cioè, LCM 600 mg/die o CBZ-CR 1200 mg/die) durante la Fase di valutazione o quella di mantenimento dello studio SP0993. 3. Pazienti in terapia con benzodiazepine per indicazioni diverse dall’epilessia. 4. Pazienti che siano stati ritenuti rispondenti a uno dei criteri per il ritiro nel precedente studio SP0993. 5. Pazienti che presentino eventi avversi gravi (SAE) in seguito alla partecipazione al precedente studio SP0993.

E.5 End points

E.5.1

Primary end point(s)

The primary safety variables are as follows: • AEs reported spontaneously by the subject and/or caregiver or observed by the investigator • Subject withdrawals due to AEs • SAEs The exploratory efficacy variables are: • Percentage of subjects seizure free • Retention rate (ie, duration of treatment in the study). The exploratory health outcomes variables are: • Health care resource use: Additional health care provider visits unforeseen by the protocol and hospitalizations

Le variabili di sicurezza principali sono le seguenti:• AE riportati spontaneamente dal paziente e/o dal caregiver, oppure osservati dallo sperimentatore; • Numero di ritiri dovuto agli AE; • SAE.Le variabili esplorative di efficacia sono: • Percentuale di pazienti liberi da crisi • Tasso di ritenzione in trattamento (cioè, durata del trattamento durante lo studio). Le variabili esplorative relative agli esiti sanitari sono: • Uso delle risorse sanitarie: ulteriori visite presso operatori sanitari non previste dal protocollo e ricoveri ospedalieri.

E.5.1.1

Timepoint(s) of evaluation of this end point

End of trial

Conclusione dello studio.

E.5.2

Secondary end point(s)

The other safety variables are as follows: • Changes in hematology, chemistry, and urinalysis parameters • Changes in 12-lead electrocardiograms (ECGs) • Changes in vital sign measurements (ie, blood pressure [BP] and pulse rate) • Changes in physical or neurological examination findings • Changes in body weight

Altre variabili di sicurezza sono: • Variazione dei parametri ematologici, chimici e urinari; • Variazione dell’elettrocardiogramma a 12 derivazioni (ECG); • Variazione dei parametri vitali (pressione e frequenza del polso); • Variazione dei risultati dell’esame obiettivo o neurologico; • Variazione del peso.

E.5.2.1

Timepoint(s) of evaluation of this end point

End of trial

Conclusione dello studio

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

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

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

Yes

E.8.1.7.1

Other trial design description

Al DB lock del SP0993 lo studio SP0994 sarà chiuso e il cieco rivelato

At DB lock of SP993,SP994 will be unblind&closed

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

115

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

Russian Federation

Ukraine

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

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)

F.1.1.5

Children (2-11years)

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:

510

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

495

F.4.2.2

In the whole clinical trial

600

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)

Following the database lock of SP0993, SP0994 will be unblinded and closed. Subjects in SP0994 who were receiving LCM will have access to open-label follow-up treatment with LCM according to local laws. Subjects who were
receiving CBZ-CR and wish to continue treatment after the close of SP0994 may receive prescribed CBZ-CR (ie, not supplied by UCB).

Al DB lock del SP0993, lo studio SP0994 sarà chiuso e il cieco rivelato. Ipazienti arruolati nello studio SP0994 che hanno assunto LCM avranno accesso al trattamento di follow-up in aperto con LCM in conformità con la legislazione locale in vigore. I pazienti che hanno assunto CBZ-CR e che vorranno continuare il trattamento dopo la chiusura dello studio SP0994, potranno procurarsi la CBZ-CR mediante prescrizione medica (il farmaco cioè non sarà fornito da UCB)

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

2012-07-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-01-03

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