A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
26 avril 2013 mis à jour par: Johnson & Johnson Pte Ltd
Open Flexible Dose Optimisation Trial Assessing Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy Who Are Treatment Naive or Have Failed One Anti-Epileptic Drug Treatment in Monotherapy
The purpose of this dose optimization study is to assess tolerability and efficacy of topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive or have failed one anti-epileptic drug (AED) treatment in monotherapy.
Aperçu de l'étude
Description détaillée
This is an open label (all people know the identity of the intervention), dose optimization trial to assess the tolerability and efficacy of topiramate as monotherapy in recently (within 5 years) diagnosed patients with epilepsy.
Treatment naive patients (patients who have never received the treatment before) and patients who failed on their first AED in monotherapy are allowed.
Failure is defined as a lack of efficacy and/or tolerability of that AED and the reason for failure is recorded by the physician.
A lack of efficacy is characterized when the patient has been treated with AED at target dose but the patient still has seizure.
Topiramate will first be titrated up to an initial target dose that will be reached after 4-6 weeks.
Further dose titration is guided by the clinical response of the individual patient, but the dose may not exceed a maximum of 400mg/day [9mg/kg/day for children].
If the patient uses an AED at entry, the AED will be fully tapered off over a period of 3 weeks, starting at the beginning of week 2, in order to have all patients on topiramate monotherapy at visit 3. Tapering the AED off may, however, extend this 3-week period if clinically indicated.
Visits will be performed at baseline and after 2, 4, 8, 12, 16 weeks.
The total duration for each patient in the study will be 4 months.
Type d'étude
Interventionnel
Inscription (Réel)
139
Phase
- Phase 4
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
5 ans à 18 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Has been diagnosed with epilepsy within the past 5 years with Primary Generalized Tonic-Clonic (PGTC) seizures as well as partial onset seizures with or without secondary generalization
- Therapy naive, or being treated with their first anti-epileptic drug (AED) in monotherapy that fails in efficacy, tolerability, or both, and not in need of a combination AED therapy
- Informed Assent in children at least 7 years and older
Exclusion Criteria:
- Have pseudoseizures or the treatable cause of the seizures (eg, metabolic disorder, toxic exposure, active infection or neoplasia)
- Has any clinically relevant progressive or serious illness (eg, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbance)
- Pregnant or breast-feeding
- Has a history or suspicion of alcohol or drug abuse
- Must have on current treatment with furosemide, hydrochlorothiazide, monoamine oxidase inhibitors
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
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Topiramate
For children: Children will start on topiramate with a dosage of 0.5mg/kg in the evening, followed by 0.5mg/kg/day weekly increments until an initial target dose of 3mg/kg/day is reached.
The total daily topiramate dose for children may, not exceed 9mg/kg/day.
For adult patients: Adult patients start on topiramate with a dosage of 25mg/day in the evening, followed by weekly increments of 25 mg/day until an initial target dose of 100mg/day is reached.
The dose of topiramate may be increased to the optimal dose with weekly increments of 0.5mg/kg/day and of 25 mg/day for children and adults, respectively at the discretion of the investigator.
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The patients will receive topiramate tablet twice daily orally up to 16 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment
Délai: Month 1, Month 3 and Month 4
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Month 1, Month 3 and Month 4
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Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment
Délai: Month 1, Month 3 and Month 4
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Month 1, Month 3 and Month 4
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Percentage of Seizure Free Participants During the Last 4 Months of Treatment
Délai: Month 1, Month 3 and Month 4
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Month 1, Month 3 and Month 4
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks
Délai: Month 1, Month 3 and Month 4
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Month 1, Month 3 and Month 4
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Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks
Délai: Month 4
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Month 4
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General Clinical Assessment Before and After Treatment
Délai: Baseline (Day 0) and Month 4
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The general clinical assessment is measured by clinical global impression scale.
The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6).
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Baseline (Day 0) and Month 4
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Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment
Délai: Month 4
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Month 4
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Janssen-Cilag VIETNAM Clinical Trial, Janssen-Cilag VIETNAM
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 mai 2008
Achèvement primaire (Réel)
1 janvier 2010
Achèvement de l'étude (Réel)
1 janvier 2010
Dates d'inscription aux études
Première soumission
23 août 2012
Première soumission répondant aux critères de contrôle qualité
17 septembre 2012
Première publication (Estimation)
21 septembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 mai 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 avril 2013
Dernière vérification
1 avril 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR017830
- TOPMATEPY4049 (Autre identifiant: Janssen-Cilag VIETNAM)
- TOP-VN -0107 (Autre identifiant: Janssen-Cilag VIETNAM)
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