Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
Information source: Eisai Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: zonisamide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Eisai Korea Inc. Official(s) and/or principal investigator(s):
Jihee Mun, Study Director, Affiliation: Medical Department, Eisai Korea Inc.
Summary
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive
therapy in patients with uncontrolled partial epilepsy.
Clinical Details
Official title: 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 design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Seizure Reduction Rate
Secondary outcome: QOLIE-31 - Investigator's Global Evaluation Scale
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.
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 once seizure per 4 weeks) last
12 weeks despite taking 1 ~ 3 antiepiletic drug(s).
4. Patient who takes 1 ~ 3 marketed antiepiletic 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 GOT/GPT/bilirubin/BUN/Creatinine level.
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.
Locations and Contacts
Bundang CHA Medical Center, Bundang, Korea, Republic of; Active, not recruiting
Dongsan Medical Center of Keimyung Univ., Daegu, Korea, Republic of; Recruiting
Yong Won Cho, Phone: 82-53-250-7114
Yeungnam Univ. Medical Center, Daegu, Korea, Republic of; Active, not recruiting
Kyungpook Natl. Univ. Hosp., Daegu, Korea, Republic of; Recruiting
Sung Pa Park, Phone: 82-53-420-5114
Natl. Health Insurance Corporation Ilsan Hosp., Ilsan, Korea, Republic of; Active, not recruiting
Gachon Univ. Gil Hosp., Incheon, Korea, Republic of; Active, not recruiting
Dong-A Medical Center, Pusan, Korea, Republic of; Active, not recruiting
Inje Univ. Pusan Paik Hosp., Pusan, Korea, Republic of; Active, not recruiting
Yunsei Severance Hospital, Seoul, Korea, Republic of; Recruiting
B.I. Lee, Phone: 82-2-2228-5230
Hallym Univ. Kangdong Sacred Heart Hosp., Seoul, Korea, Republic of; Recruiting
Hong Ki Song, Phone: 82-2-2224-2114
Additional Information
Starting date: September 2007
Last updated: June 8, 2010
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