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    Summary
    EudraCT Number:2011-003100-21
    Sponsor's Protocol Code Number:SP0982
    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:2015-05-08
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-003100-21
    A.3Full title of the trial
    A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY FOR UNCONTROLLED PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN SUBJECTS WITH IDIOPATHIC GENERALIZED EPILEPSY
    ESTUDIO DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO, DE GRUPOS PARALELOS, MULTICÉNTRICO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE LACOSAMIDA COMO TRATAMIENTO COMPLEMENTARIO PARA LAS CRISIS TÓNICO-CLÓNICAS GENERALIZADAS PRIMARIAS NO CONTROLADAS EN PACIENTES CON EPILEPSIA IDIOPÁTICA GENERALIZADA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and efficacy of Lacosamide versus placebo (a pill without active medication) in patients with idiopathic generalised epilepsy who are already taking anti-epileptic medications
    Estudio para evaluar la seguridad y la eficacia de Lacosimida frente a placebo ( una píldora sin medicación activa) en pacientes con epilepsia idiopática generalizada que están tomando medicación antiepileptica.
    A.4.1Sponsor's protocol code numberSP0982
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/275/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB BIOSCIENCES, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB BIOSCIENCES, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number900 811 335
    B.5.5Fax number+492173 48 1572
    B.5.6E-mailclinicaltrials@ucb.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vimpat 50 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLacosamide
    D.3.2Product code SPM927
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLACOSAMIDE
    D.3.9.2Current sponsor codeSPM 927
    D.3.9.4EV Substance CodeSUB25407
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vimpat 10mg/ml Oral Solution
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLacosamide
    D.3.2Product code SPM927
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLACOSAMIDE
    D.3.9.2Current sponsor codeSPM 927
    D.3.9.4EV Substance CodeSUB25407
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epilepsy
    Epilepsia
    E.1.1.1Medical condition in easily understood language
    Idiopathic generalized epilepsy
    Epilepsia idiopatica generalizada
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071096
    E.1.2Term Idiopathic generalized epilepsy
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of oral lacosamide (LCM) vs placebo as adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy (IGE) currently taking 1 to 3 concomitant anti-epileptic drugs (AEDs) independent of the number of prior failed AEDs
    Demostrar la eficacia de lacosamida oral ( LCM) frente a placebo como tratamiento complementario para las crisis generalizadas toniclonicas (TCGP) no controladas en pacientes con epilepsia idiopatica generalizada (EIG) actualmente tratados con 1 a 3 fármacos antiepilepticos (FAE) concomitantes independientemente del número de fracasos previos de FAEs.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of lacosamide (LCM) in subjects with idiopathic generalized epilepsy (IGE) with uncontrolled primary generalized tonic-clonic (PGTC) seizures
    Evaluar la seguridad y la tolerabilidad de lacosamida (LCM) en pacientes con epilepsia idiopatica generalizada (EIG) y crisis tonicoclonicas generalizadas primasrias (TCGP) no controladas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981).

    ? Subject has >=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)

    ? If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures.

    ? Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed Anti-epileptic drugs (AEDs) OR 1 to 3 AEDs (with at least 1 AED identified as a benzodiazepine) for at least 28 days prior to Visit 1 with or without additional concurrent stable Vagus nerve stimulation (VNS).

    ? Subjects are required to have had an electroencephalogram (EEG) report consistent with IGE (eg, generalized >= 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer.
    ?Paciente con un diagnóstico confirmado al menos 24 semanas antes de la Visita 1 y aparición de la enfermedad antes de los 30 años de edad, compatible con EIG con crisis TCGP (Tipo IIE) que pueden clasificarse de acuerdo a la Clasificación de las crisis epilépticas de ILAE (ILAE, 1981).
    ?Paciente que tiene >= 3 crisis TCGP durante el periodo combinado inicial de 16 semanas (histórico inicial de 12 semanas más prospectivo inicial de 4 semanas)
    ?Si se ha realizado una exploración cerebral por resonancia magnética (RM)/tomografía computerizada (TAC), no debe haber ninguna evidencia de anomalías progresivas o de ninguna lesión que pueda asociarse con crisis parciales.
    ?Paciente que se ha mantenido en una pauta posológica estable de 1 a 2 FAE no benzodiacepínicos comercializados O BIEN de 1 a 3 FAE (con al menos 1 FAE identificado como una benzodiacepina) durante al menos 28 días antes de la Visita 1 con o sin ENV estable concurrente adicional.
    ? Se requiere que los pacientes hayan obtenido un informe de EEG compatible con EIG (por ejemplo, descargas epileptiformes >= 3 Hz generalizadas y un fondo normal de EEG) confirmado por un revisor central
    E.4Principal exclusion criteria
    ? History of partial onset seizures or EEG findings indicating partial onset seizures

    ? Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome

    ? Lifetime history of suicide attempt, or suicidal ideation in past 6 months

    ? Women of child bearing potential must practice contraception according to protocol requirements

    ? Regular use of neuroleptics, narcotics, monoamine oxidase (MOA) inhibitors, barbiturates (for indication other than epilepsy) within 28 days prior to Visit 1

    ? Use of Felbamate or Vigabatrin within last 6 months

    ? Subject is on a ketogenic diet
    ?Antecedentes de crisis parciales o hallazgos de EEG indicativos de crisis parciales.
    ?Epilepsia generalizada sintomática por ejemplo, el síndrome de Lennox-Gastaut.
    ?Antecedentes de intentos de suicidio, o idea de suicidio en los últimos seis meses.
    ?Las mujeres en edad fertil deben poner en practivo un metodo anticonceptivo de acuerdo a los requisitos del protocolo.
    ?Uso regular de neurolepticos, narcoticos, inhibidores de la monoamino oxidasa (MAO), barbituricos (para otra indicación distinta a la epilepsiaI en los 28 días previos a la visita 1
    ?Uso de felbamato o Vigabatrin en los últimos seis meses.
    ?El paciente sigue una dieta cetógena.
    E.5 End points
    E.5.1Primary end point(s)
    Time to the second primary generalized tonic clonic (PGTC) seizure
    el tiempo hasta la segunda crisis tonicoclonica generalizada primaria (TCGP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
    Periodo de Tratamiento de 24 semanas desde la Visita 2 (Semana 0) a la Visita 10 (semana 24)
    E.5.2Secondary end point(s)
    Seizure freedom for primary generalized tonic clonic (PGTC) seizures

    The percent change in primary generalized tonic clonic (PGTC) seizure frequency per 28 days

    Time to the first primary generalized tonic clonic (PGTC) seizure
    Ausencia de crisis para las crisis tonicoclonica generalizada primaria (TCGP)

    El porcentaje de cambio en la frecuencia de crisis tonicoclonica generalizada primaria (TCGP) por cada 28 días

    Tiempo hasta la primera crisis tonicoclonica generalizada primaria (TCGP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

    From the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the first 6 weeks of the Treatment Period
    Periodo de Tratamiento de 24 semanas desde la Visita 2 (Semana 0) a la Visita 10 (semana 24)

    Desde el periodo combinado inicial (histórico de 12 semanas y prospectivo inicial de 4 semanas combinados) hasta las primeras 6 semanas del período de tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Brazil
    Bulgaria
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Spain
    Taiwan
    Turkey
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Ultima Visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 97
    F.4.2.2In the whole clinical trial 200
    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 can enter open label study after the completion of Visit 10 (Week 24) or End of Treatment Visit and a 4-week blinded transition. Subjects who choose not to continue in open label study must complete an up to 4-week blinded taper followed by a 30-day Safety Follow-up Period
    Los pacientes pueden entrar en el ensayo de extensión abierto tras la visita 10 (semana 24) o la visita de fin de tratamiento y realizarán una transición enmascarada de 4 semanas. Los pacientes que decidan no continuar en el estudio abierto deberán someterse a una reducción progresiva enmascarada de 4 semanaa seguida de un período de seguimiento de la seguridad de 30 días.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-05
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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