A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

Eisai Korea Inc.0 个研究点目标入组 121 人开始时间: 2017年4月24日最近更新: 2017年5月8日

适应症

试验速览

暂无简介。

•1. Epilepsy participant over 15 years old who agrees with Informed Consent Form
•2. Participant who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.
•3. Participant who has 3 ~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 ~ 3 antiepileptic drug(s).
•4. Participant who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.
•5. Before study visit, participant who takes stable dose of antiepileptic drug more than 4 weeks.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 121
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 121
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 121

•1. Participant who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
•2. Participant who experiences pseudoseizures and/or who has uncountable clusters.
•3. Participant who has serious systemic or drug metabolism affecting disorder .
•4. Upward of doubled normal alanine transaminase (ALT), aspartate transaminase (AST), bilirubin, blood urea nitrogen (BUN), creatinine levels.
•5. Participant who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.
•6. Participant who has medical history of renal stones.
•7. Participant who is allergic to sulfonamide.
•8. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.
•9. Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.
•10. A terminal participant and/or a scheduled surgical participant.
•11. Participant who has medication history of zonisamide.
•12. Participant who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.

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