E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epilepsy with Partial Onset Seizures |
Epilepsia con crisis de inicio parcial |
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E.1.1.1 | Medical condition in easily understood language |
Epilepsy with partial-onset seizures |
Epilepsia con crisis de inicio parcial |
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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 | 16.1 |
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 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the long-term safety and tolerability of lacosamide in pediatric subjects |
Evaluar la seguridad y la tolerabilidad del tratamiento a largo plazo con lacosamida en sujetos pediátricos. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of lacosamide during long-term exposure in pediatric subjects |
Evaluar la eficacia de la lacosamida como tratamiento a largo plazo en sujetos pediátricos. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors. 2. Subject has completed the Transition Period of SP0967 or SP0969 for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy. 3. Subject is expected to benefit from participation, in the opinion of the investigator. 4. 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. |
1. Firma y fecha, por parte del sujeto o del representante legal, del documento de consentimiento informado aprobado por el comité ético de investigación clínica (CEIC). Los menores firmarán un documento de consentimiento especial en los territorios donde así lo exija la legislación. 2. Haber terminado el período de transición de los ensayos SP0967 o SP0969 para el tratamiento pediátrico de las crisis epilépticas parciales no controladas. 3. Previsión de que la participación en el estudio vaya a beneficiar al sujeto, en opinión del investigador. 4. Capacidad del sujeto o del representante legal de cumplir con el protocolo (p. ej., entender y cumplimentar los diarios), con el calendario de visitas y con la toma de la medicación, según determine el investigador. |
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E.4 | Principal exclusion criteria |
1. Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide. 2. Subject is experiencing an ongoing serious AE (SAE). 3. For subjects >=6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (?Yes?) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1. 4. Subjects with a major protocol deviation during the primary study (or a deviation related to enrollment criteria for primary study). 5. Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception (according to the International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate <1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme-inducing antiepileptic drugs (EI-AEDs: carbamazepine, phenytoin, barbiturates, primidone, topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly effective method of contraception according to the World Health Organization recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI-AEDs OR does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study. |
1. Tratamiento con un fármaco o producto sanitario en fase de investigación, aparte de la lacosamida. 2. Presencia de un acontecimiento adverso grave (AAG) en curso. 3. En el caso de los sujetos >= 6 años, antecedentes de intento de suicidio en cualquier momento de su vida (intentos activos, interrumpidos o abortados) o ideas suicidas en los últimos 6 meses según la respuesta afirmativa («sí») a las preguntas 4 ó 5 de la escala de Columbia para la evaluación del riesgo de suicidio (C-SSRS) en la visita 1. 4. Desviación importante del protocolo durante el ensayo clínico de procedencia (o desviación relacionada con los criterios de selección de ese ensayo). 5. En el caso de las chicas, embarazo o lactancia materna; si ya han pasado la menarquia, deben haberse sometido a una esterilización quirúrgica, comprometerse a emplear un método anticonceptivo de gran eficacia (según la definición de la Conferencia Internacional de Armonización [ICH]: métodos cuyo índice de fracaso sea inferior al 1% anual si se utilizan de forma correcta) o abstenerse por completo de mantener relaciones sexuales durante el estudio. Las chicas que sean fértiles y tomen inductores enzimáticos (carbamazepina, fenitoína, barbitúricos, primidona, topiramato, oxcarbazepina) deben haberse sometido a una esterilización quirúrgica, comprometerse a emplear un método anticonceptivo de gran eficacia según lo recomendado por la OMS (acetato de medroxiprogesterona, enantato de noretisterona, dispositivo intrauterino, inyecciones combinadas e implantes de progestágeno) O BIEN practicar al mismo tiempo 2 métodos anticonceptivos (p. ej., un anticonceptivo hormonal junto con un método mecánico de barrera y espermicida) durante todo el estudio, salvo que se comprometan a abstenerse de mantener relaciones sexuales. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study 2) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study |
1) Número de sujetos que comunican al menos un acontecimiento adverso aparecido durante el tratamiento durante el estudio 2) Número de sujetos que comunican al menos un acontecimiento adverso aparecido durante el tratamiento que conlleva la retirada del estudio |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) From Baseline to End of Treatment period 2) From Baseline to End of Treatment |
1) desde la frecuencia basal hasta el final del periodo de tratamiento 2) desde la frecuencia basal hasta el fin del tratamiento |
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E.5.2 | Secondary end point(s) |
1) Percentage of seizure free days at the end of Year 1; 2) Percentage of seizure free days at end of Year 2 |
1) Porcentaje de días sin convulsiones al final del año 1 2) Porcentaje de días sin convulsiones al final del año 2 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) End of Year 1 of the Study (approximately 52 weeks) 2) End of Year 2 of the Study (approximately 96 weeks) |
1) Fin del año 1 del estudio (aproximadamente 52 semanas) 2) Fin del año 2 del estudio (aproximadamente 96 semanas) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
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 | No |
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 |
Serbia |
Argentina |
Australia |
Brazil |
Chile |
Colombia |
European Union |
Japan |
Korea, Republic of |
Thailand |
Israel |
Mexico |
Russian Federation |
South Africa |
Switzerland |
Taiwan |
Turkey |
Ukraine |
United States |
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E.8.7 | Trial 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 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |