Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

Overview

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2010

Detailed Description

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 ~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures [SPS], complex partial seizures [CPS], simple partial seizures evolving into generalized tonic-clonic convulsions [SGTC] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.

Interventions

  • Drug: zonisamide
    • zonisamide 100 mg tablet

Arms, Groups and Cohorts

  • Experimental: 1

Clinical Trial Outcome Measures

Primary Measures

  • Seizure Reduction Rate
    • Time Frame: Baseline and 16 weeks
    • The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.

Secondary Measures

  • Seizure Free Rate
    • Time Frame: 16 weeks
    • The percentage of the participants who experienced no seizure during the trial.
  • Responder Rate
    • Time Frame: Baseline and 16 weeks
    • The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.
  • QoL-QOLIE31 (Quality of Life in Epilepsy)
    • Time Frame: Baseline and 16 weeks
    • Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.

Participating in This Clinical Trial

Inclusion Criteria

1. Epilepsy patient over 15 years old who agrees with Informed Consent Form 2. Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures. 3. Patient 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. Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time. 5. Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks. Exclusion criteria:

1. Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain. 2. Patient who experiences pseudoseizures and/or who has uncountable clusters. 3. Patient who has serious systemic or drug metabolism affecting disorder . 4. Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels. 5. Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3. 6. Patient who has medical history of renal stones. 7. Patient 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 patient and/or a scheduled surgical patient. 11. Patient who has medication history of zonisamide. 12. Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Korea Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jihee Mun, Study Director, Medical Department, Eisai Korea Inc.

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