E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic generalized epilepsy |
Epilepsia idiopatica generalizada |
|
E.1.1.1 | Medical condition in easily understood language |
Idiopathic generalized epilepsy |
Epilepsia idiopatica generalizada |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 |
The primary objective is to assess the safety and tolerability of LCM as an adjunctive therapy for uncontrolled PGTC seizures in subjects with IGE during long-term exposure. |
El objetivo principal es evaluar la seguridad y tolerabilidad de LCM como tratamiento complementario para las crisis TCGP no controladas en pacientes con EIG durante una exposición a largo plazo. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are: - To assess the efficacy of adjunctive LCM therapy during long-term exposure for the treatment of subjects with IGE experiencing uncontrolled PGTC seizures - To allow subjects who have completed SP0982 and eligible Baseline failures from SP0982 to receive LCM |
Los objetivos secundarios son: - Evaluar la eficacia del tratamiento complementario con LCM durante una exposición a largo plazo para el tratamiento de pacientes con EIG que experimentan crisis TCGP no controladas. - Permitir que los pacientes que hayan completado el SP0982 y los fallos de selección del SP0982 que reúnan los requisitos reciban LCM. |
|
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/Assent Form for the open-label extension study (EP0012) must be 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 must have completed or be an eligible Baseline failure from the parent study (SP0982), as defined in protocol Section 5.1.
3. Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (eg, able to understand and complete diaries and questionnaires), visit schedule and medication intake according to the judgment of the investigator. |
1.El consentimiento/asentimiento informado, aprobado por la Junta de Revisión Institucional (JRI)/Comité ético de Investigación Clínica (CEIC) para el estudio de extensión abierto (EP0012) debe ser firmado y fechado por el paciente o por sus padres o su representante legal. El formulario de consentimiento informado o un formulario de asentimiento específico, cuando sea necesario, serán firmados y fechados por los menores de edad. 2.El paciente debe haber completado o ser un fallo de selección del estudio original (SP0982), como se definió en la Sección 5.1. 3.El paciente o su representante legal se considera fiable y capaz de cumplir con el protocolo (por ejemplo, capaz de entender y cumplimentar diarios y cuestionarios), el calendario de visitas y tomar la medicación, a juicio del investigador. |
|
E.4 | Principal exclusion criteria |
1. Subject is receiving any investigational drugs or using any experimental devices in addition to LCM.
2. Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE).
3.Subject has an active suicidal ideation as indicated by a positive response (?Yes?) to either Question 4 or Question 5 of the ?Since Last Visit? version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The subject should be referred immediately to a Mental Healthcare Professional. |
1.El paciente está recibiendo algún fármaco en investigación o usando dispositivos experimentales, además de la LCM. 2.El paciente cumple los criterios para la retirada del SP0982 o está experimentando un acontecimiento adverso grave (AAG). 3.El paciente tiene ideas de suicidio activas como lo indica una respuesta positiva (?Sí?) a la pregunta 4 o la pregunta 5 de la versión ?Desde la última visita? de la escala Columbia-Suicide Severity Rating Scale (C-SSRS). El paciente debe ser derivado inmediatamente a un profesional de salud mental. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Adverse events as reported spontaneously by the subject and/or caregiver or observed by the investigator
Subject withdrawals due to AEs |
Los acontecimientos adversos notificados de forma espontánea por el paciente y/o el cuidador o observados por el investigador. Retiradas de pacientes debido a AA. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 5 years |
Hasta 5 años |
|
E.5.2 | Secondary end point(s) |
Changes in hematology, chemistry, and urinalysis parameters
Changes in 12-lead ECGs
Changes in vital sign measurements (ie, BP and pulse rate), including body weight and physical (including neurological) examination findings |
Los cambios en los parámetros de hematología, bioquímica y del análisis de orina.
Los cambios en el ECG de 12 derivaciones.
Los cambios en las mediciones de las constantes vitales (es decir, TA y la frecuencia del pulso), incluidos el peso corporal y los hallazgos de la exploración física (incluidos los neurológicos). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 5 years |
Hasta 5 años |
|
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 | Yes |
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.8.3 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 73 |
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 |
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.8.7 | 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 ultimo paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |