A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.
23 janvier 2014 mis à jour par: Eisai Inc.
Evaluation of Safety and Efficacy of Zonisamide in Adult Patients With Partial, Generalized and Combined Seizures: An Open Labeled, Non-comparative, Observational Study
The purpose of this study is to evaluate the safety and efficacy of zonisamide in the treatment of adult patients with partial, generalized or combined seizures.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This is an open labeled non-comparative, multicentric observational post marketing surveillance study to comparing the safety and efficacy of zonisamide as adjunctive therapy or monotherapy in patients with partial, generalized or combined seizures, in a initiating dose of 100mg/day titrated to a maximum of 600mg per day based on the seizure control and tolerability over a 24 weeks treatment period.
This study will include a total of 900 patients with partial, generalized or combined seizures across 30 centres in the country.
The patients will be enrolled based on the inclusion and exclusion criteria and will be evaluated for safety and efficacy at every 4 weekly interval for 24 weeks.
There will be total 7 study visits and the patients will be evaluated for clinically reportable adverse events, safety on Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale and for efficacy by evaluation of reduction in seizure frequency as the primary objective of the study.
For secondary objectives the patients data will be evaluated to determine the responder rates (> or = to 50% reduction in seizure frequency from baseline) and seizure freedom over the 24 weeks study period.
Type d'étude
Observationnel
Inscription (Réel)
655
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New Delhi, Inde, 110070
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Inde, 500016
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Hyderabad, Andhra Pradesh, Inde, 500027
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Hyderabad, Andhra Pradesh, Inde, 500057
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Secunderabad, Andhra Pradesh, Inde, 500003
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Secunderabad, Andhra Pradesh, Inde, 500015
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Vijaywada, Andhra Pradesh, Inde
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Vishakapatnam, Andhra Pradesh, Inde
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Vishakhapatnam, Andhra Pradesh, Inde, 530002
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Gujarat
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Ahmedabad, Gujarat, Inde, 380009
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Gujrat
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Ahmedabad, Gujrat, Inde, 380015
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Karanataka
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Bangalore, Karanataka, Inde, 560010
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Kerela
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Kochi, Kerela, Inde, 682012
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Kochi, Kerela, Inde, 682301
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Maharashtra
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Mumbai, Maharashtra, Inde, 400012
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Mumbai, Maharashtra, Inde, 400049
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Pune, Maharashtra, Inde
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Rajastan
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Jaipur, Rajastan, Inde, 302004
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Jaipur, Rajastan, Inde, 302015
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Jaipur, Rajastan, Inde, 302017
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Tamilnadu
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Chennai, Tamilnadu, Inde, 500017
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Chennai, Tamilnadu, Inde, 600006
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Chennai, Tamilnadu, Inde, 600010
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Chennai, Tamilnadu, Inde, 600017
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Uttar Pradesh
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Lucknow, Uttar Pradesh, Inde, 226003
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Lucknow, Uttar Pradesh, Inde, 226022
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Noida, Uttar Pradesh, Inde, 201301
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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
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Single Cohort Study involving community patients with epilepsy
La description
Inclusion Criteria:
- Male or female subjects, 18 to 75 years of age inclusive
Treated or untreated subjects suffering from any of the following types of seizures:
- Partial Seizures: Simple Partial Seizures, Complex Partial Seizures & Secondarily generalized tonic clonic seizures
- Generalized Seizures: Tonic-clonic seizures, tonic seizures & Atypical absence seizures
- Combined seizures (mixed)
- Subjects having had a computed tomography (CT) or magnetic resonance imaging (MRI) done within the last upto 10 years that ruled a progressive cause of epilepsy.
- Female subjects without child bearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible.
- Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and enrollment must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug.
- Patients willing to take the medications as directed, maintain a seizure dairy, report adverse events and willing to come for the follow-ups as per schedule.
- Willing to comply with the protocol requirements.
- Able and willing to give the written informed consent.
Exclusion Criteria:
- Subjects with history of non-epileptic seizures (e.g. metabolic, pseudo-seizures).
- Subjects who have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation related seizures.
- Subjects with progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination or tumour).
- Subjects with a history of any significant or currently uncontrolled disease which in the opinion of the investigator will interfere with the conduct of this study or the assessment of safety & efficacy of the study drug.
- Subjects already receiving zonisamide therapy.
- Subjects who have received an investigational new drug or device in the past three months before screening and enrollment.
- Subjects with known hypersensitivity to zonisamide or sulphonamides.
- Subjects with known abnormal renal function (serum creatinine > 1.5 mg/dL) or abnormal hepatic function (Aspartate aminotransferase [AST] and alanine aminotransferase [ALT] > 2 times the upper normal limit).
- Subjects with a history of psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse.
- Subjects currently taking carbonic anhydrase inhibitors (acetazolamide).
- Subjects currently taking Mono-Amine Oxidase Inhibitor's (MAO-I's).
- Subjects having a history of pancreatitis, nephrolithiasis or hypercalciuria, clinically significant laboratory abnormalities suggestive of metabolic imbalance
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
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Expérimental
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zonisamide 100mg tablets
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Assess safety with zonisamide therapy in adult patients with different seizure types
Délai: 24 weeks
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24 weeks
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Assess reduction in seizure frequency with zonisamide therapy in adult patients with different seizure types
Délai: 24 weeks
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24 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures
Délai: 24 weeks
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24 weeks
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To evaluate seizure freedom over 24 weeks of zonisamide treatment in adult patient with seizures
Délai: 24 weeks
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24 weeks
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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: Amitabh Dash, Eisai Pharmaceuticals India Private limited
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 janvier 2011
Achèvement primaire (Réel)
1 janvier 2013
Achèvement de l'étude (Réel)
1 mai 2013
Dates d'inscription aux études
Première soumission
24 janvier 2011
Première soumission répondant aux critères de contrôle qualité
24 janvier 2011
Première publication (Estimation)
25 janvier 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 janvier 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 janvier 2014
Dernière vérification
1 janvier 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EIL/ZONE/CT01/2010
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