A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
26 avril 2010 mis à jour par: Janssen Cilag Pharmaceutica S.A.C.I., Greece
An Open-label Observation Study of Topiramate Administration as Adjuvant Therapy for Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures and Generalized Tonoclonic Seizures in Adults and Children Aged 2 Years and Older
The purpose of this observational study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children.
Aperçu de l'étude
Description détaillée
Topiramate is a medication that is approved for the treatment of seizures.
In accordance with International guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety.
This is an open-label, multi-center observational safety study to collect safety information for oral topiramate given in addition to other medications for 3 types of seizures in adults and in children aged 2 years and older.The 3 seizures types are focal epilepsy, LENNOX-GASTAUT syndrome epileptic seizures and generalized tonic-clonic seizures.
Patients whose previous treatment for seizures (one or more antiepileptic drugs) has been judged by their physician to be non-satisfactory will receive 6 months of treatment with topiramate in addition to other antiepileptic medication as prescribed by their physician.
Topiramate will be given at low doses initially and gradually increased as necessary to control seizure activity in accordance with Summary of Product Characteristics (SmPC).
Patients will be asked to keep a diary of adverse events and seizure activity.
Safety evaluations (incidence of adverse events, physical examinations, vital signs and laboratory tests) will be performed throughout the study per investigators usual standard of care.
At the end of the study, the treating physician may continue treatment with topiramate and other medication as appropriate.
The study hypothesis is that topiramate given in combination with other antiepileptic medications will be effective in achieving and maintaining control of seizure activity and is well-tolerated.
225 adult patients and children aged 2 years or older will be enrolled in the study.
Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the investigator as non-satisfactory.
Observational study - No investigational drug administered.
Type d'étude
Observationnel
Inscription (Réel)
153
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
2 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
225 adult patients and children aged 2 years or older will be enrolled in the study.
Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who should have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the inverstigator as non-satisfactory.
La description
Inclusion Criteria:
- Non-premenopausal female patients using a medically acceptable contraceptive method as discussed with their doctor
- History of the type of seizure during the period prior to inclusion in the study and sufficient medical records to document this. Prior treatment until inclusion in the study with one or more antiepileptic drug treatment judged non-satisfactory by the investigator
Exclusion Criteria:
- Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor
- Patients with a history of generalized status epilepticus (prolonged seizures) within the last three months
- Patients with progressive brain tumor or other progressive or degenerative disorders
- Patients with a history (within the previous six months) of mental or emotional disorders requiring shock treatment or major sedation, monoamine oxidase (MAO) inhibitors or medications which affect the central nervous system
- Patients with any medical or social condition that may affect their ability to take part in study or the safety of the study
- Patients who cannot take the drug or fill in the diary, either alone or with help. If help is needed, it should be permanently available throughout the study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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001
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Individualization of the treatment should begin from 25 mg for 1 week.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Evaluation of the safety of oral topiramate as adjuvant therapy for focal epilepsy, Lennox-Gastaut syndrome epileptic seizures and the generalized tonoclonic seizures in adults and children aged 2 years and older.
Délai: At visit 3-8
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At visit 3-8
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Safety & tolerability evaluation will be performed by reporting AEs & Clinical labs.
Délai: Visits:3-8
|
Visits:3-8
|
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Evaluation of efficacy will be performed with the aid of descriptive statistics.
Délai: Visits:3-8
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Visits:3-8
|
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Overall assessments of the improvement in the seriousness of seizures will be performed.
Délai: Visits:3-8
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Visits:3-8
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2003
Achèvement de l'étude (Réel)
1 juin 2005
Dates d'inscription aux études
Première soumission
24 février 2006
Première soumission répondant aux critères de contrôle qualité
24 février 2006
Première publication (Estimation)
28 février 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 avril 2010
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 avril 2010
Dernière vérification
1 avril 2010
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR003472
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