E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epilepsy with partial-onset seizures or generalized tonic-clonic seizures |
Epilepsie avec crises épileptiques à début partiel ou tonico-cloniques généralisées |
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E.1.1.1 | Medical condition in easily understood language |
Epilepsy with partial-onset seizures |
Epilepsie avec crises épileptiques à début partiel |
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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 | 18.1 |
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 dosed at 200mg/day to 600mg/day when used as monotherapy in subjects, with partial-onset seizures or generalized tonic-clonic seizures (without clear focal origin), who completed SP0994. |
Evaluer la tolérance et la sécurité d'emploi à long terme du Lacosamide administré à une dose de 200 à 600 mg/jour en monothérapie chez des patients atteints de crises épileptiques à début partiel ou tonico-cloniques généralisées (sans origine focale claire), ayant terminé l'étude SP0994 . |
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E.2.2 | Secondary objectives of the trial |
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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 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, visit schedule, and medication intake according to the judgment of the investigator.
3. Subject has completed the Termination Visit of SP0994 and has been treated with Lacosamide monotherapy. |
1.Signature et datage par le patient ou se(s) parent(s) ou son(ses) représentant(s) légal(ux) du formulaire de consentement éclairé écrit approuvé par le Comité de protection des personnes. Le formulaire de consentement éclairé ou un formulaire spécifique pour les mineurs, le cas échéant, sera signé et daté par les mineurs.
2.Patient/représentant légal considéré fiable et capable de respecter le protocole, le calendrier des visites, et la prise de médicaments, d'après le jugement de l'investigateur.
3.Patient ayant effectué la Visite de fin de l'étude SP0994 et ayant été traité par Lacosamide en monothérapie.
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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 experienced a seizure at the third target dose (ie, Lacosamide 600 mg/day) during SP0994.
3. Subject requires another antiepileptic drug for the treatment of seizures.
4. Subject meets a “must” withdrawal criterion for the previous study, SP0994.
5. Subject is experiencing an ongoing serious adverse event from the previous study, SP0994.
6. Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception (according to ICH guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. |
1.Administration d'un autre médicament à l'étude ou utilisation d'un dispositif à l'étude, en plus du traitement par Lacosamide.
2.Survenue d'une crise d'épilepsie à la troisième dose ciblée (c'est-à-dire, Lacosamide 600 mg/jour) pendant l'étude SP0994.
3.Nécessité d'un autre médicament anti-épileptique pour le traitement des crises d'épilepsie.
4.Présence d'un critère de retrait « obligatoire » lors de la précédente étude, SP0994.
5.Persistance d'un évènement indésirable grave depuis la précédente étude, SP0994.
6.Patiente en cours de grossesse ou d'allaitement et/ou femme en âge de procréer n'ayant pas été stérilisée chirurgicalement, non ménopausée depuis 2 ans ou n'utilisant pas de méthode de contraception hautement efficace (définie par les directives ICH (conférence internationale d'harmonisation) comme toute méthode ayant un taux d'échec inférieur à 1 % par an lors d'une utilisation constante et conforme), sauf en cas d'abstinence sexuelle complète, pendant toute la durée de l'étude.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of adverse events reported spontaneously by the subject and/or caregiver or observed by the investigator
2. Percentage of withdrawals due to adverse events
3. Number of serious adverse events reported spontaneously by the subject and/or caregiver or observed by the investigator
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1. Nombre d'évènements indésirables décrits spontanément par le patient et/ou le soignant ou observés par l'investigateur
2. Pourcentage d'abandons dus aux évènements indésirables
3. Nombre d'évènements indésirables graves décrits spontanément par le patient et/ou le soignant ou observés par l'investigateur
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Visit 1 (Week 0) to Final Visit (up to week 158) |
De la Visite 1 (semaine 0) à la dernière visite (jusqu'à la semaine 158) |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 |
Bulgaria |
Finland |
France |
Germany |
Japan |
Korea, Republic of |
Latvia |
Mexico |
Philippines |
Poland |
Russian Federation |
Sweden |
Switzerland |
Ukraine |
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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
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LVLS |
Dernière visite du dernier patient |
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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 | 10 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |