Clinical Trials Register

Summary
EudraCT Number:	2010-021238-74
Sponsor's Protocol Code Number:	SP0994
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-10-26
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2010-021238-74

A.3

Full title of the trial

ESTUDIO DE SEGUIMIENTO, MULTICÉNTRICO, DOBLE
CIEGO Y DOBLE SIMULACIÓN, PARA EVALUAR LA
SEGURIDAD A LARGO PLAZO DE LACOSAMIDA (200 A
600 MG/DÍA) FRENTE A CARBAMAZEPINA (400 A 1.200
MG/DÍA), ADMINISTRADAS EN MONOTERAPIA, EN
SUJETOS (IGUAL O MAYOR DE 16 AÑOS) AFECTOS DE CRISIS DE COMIENZO PARCIAL O TÓNICO-CLÓNICAS
GENERALIZADAS PROCEDENTES DEL ESTUDIO SP0993 //

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 OR OLDER COMING FROM THE SP0993 STUDY

A.4.1

Sponsor's protocol code number

SP0994

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SCHWARZ 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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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 50 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB PHARMA SA
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.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	LACOSAMIDA
D.3.9.3	Other descriptive name	LACOSAMIDA
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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 limited
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.3.1	Product name	Carbamazepine controlled release; Carbamazepina retard
D.3.4	Pharmaceutical form	Prolonged-release capsule, soft
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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 100 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB PHARMA SA
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.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	LACOSAMIDA
D.3.9.3	Other descriptive name	LACOSAMIDA
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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.8.4	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

Epilepsia de diagnóstico nuevo o reciente y afectos de crisis tónico-clónicas de comienzo parcial o generalizadas.//

Epilepsy; partial onset or generalized tonic clonic seizures

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10015037
E.1.2	Term	Epilepsy

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

-Obtener información acerca de la seguridad a largo plazo de la LCM en comparación con
CBZ-CR en su administración en monoterapia a sujetos con diagnóstico reciente de crisis
de comienzo parcial o crisis tónico-crónicas generalizadas.
-Permitir a los sujetos que completen el estudio de monoterapia SP0993 continuar
recibiendo LCM o CBZ-CR. ///

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

E.2.2

Secondary objectives of the trial

Consultar sección 4.1.2. y 4.2 del protocolo.///

See section 4.1.2 and 4.2 of the protocol.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. El sujeto, su progenitor o progenitores o su representante legal han firmado y fechado un
documento de consentimiento informado por escrito, aprobado por un comité ético de
investigación clínica (CEIC)/Institutional Review Board (IRB). Los menores firmarán y
fecharán el documento de consentimiento u otro de asentimiento específico, en su caso.
2. A juicio del investigador, se considera que el sujeto/representante legal es fiable y capaz
de cumplir lo señalado en el protocolo (por ejemplo, es capaz de comprender y
cumplimentar los diarios), el calendario de visitas y la toma de medicación.
3. El sujeto ha permanecido sin crisis y ha completado la fase de mantenimiento del estudio
de monoterapia SP0993; o el sujeto ha presentado una o más crisis con la primera o
segunda dosis objetivo durante la fase de mantenimiento del estudio SP0993.
4. En opinión del investigador, se espera que el sujeto se beneficie de su participación en el
estudio SP0994. //

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.

E.4

Principal exclusion criteria

1. El sujeto está recibiendo cualquier medicamento en investigación o está utilizando
cualquier producto sanitario (dispositivo) experimental además de la LCM o la CBZ-CR.
2. El sujeto ha presentado una crisis con la tercera dosis objetivo (es decir, 600 mg/día de
LCM o 1200 mg/día de CBZ-CR) durante la fase de evaluación o la fase de
mantenimiento del estudio SP0993.
3. El sujeto está recibiendo benzodiacepinas para una indicación distinta de la epilepsia.
4. El sujeto cumple un criterio de retirada del estudio SP0993 anterior.
5. El sujeto sigue presentando un acontecimiento adverso grave (SAE) del estudio SP0993
anterior.//
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.

E.5 End points

E.5.1

Primary end point(s)

Las variables de seguridad principales son las siguientes:
-AE comunicados de manera espontánea por el sujeto y/o el cuidador, u observados por el
investigador.
-Retiradas de sujetos debido a AE.
-SAE.
///
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

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

After database lock of SP993,SP994 will be unblinded &closed. Open label acces according to law.

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.8.3

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

100

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

Information not present in EudraCT

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

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

El final del ensayo está definido como la fecha de la última visita del último sujeto en el estudio. //

The end of the study is defined as the date of the last visit of the last subject in the study.

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.1.1.1

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.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

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)

Plans for treatment or medical care after subject has ended his/her participation in the trial are detailed in the study protocol in:
? Section 6.3 "Subject Withdrawal".
? Section 8.3 "End of study phase"
? Sections 8.1.15 "Early Termination/Termination Visit"

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

2011-02-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-02-04

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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