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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140867
• Other study ID #: E2090-S082-409
• Status: Completed
• Phase: Phase 4
• Start date: February 29, 2008
• Est. completion date: March 31, 2011

Study information

• Verified date: May 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 31, 2011
• Est. primary completion date: August 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

Drug:
• zonisamide
zonisamide 100 mg tablet

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital, Dept. of Neurology	Busan
Korea, Republic of	Inje Univ. Pusan Paik Hospital, Dept. of Neurology	Busan
Korea, Republic of	Keimyung Univ.Dongsan Medical Centre, Dept. of Neurology	Daegu
Korea, Republic of	Kyungpook Natl. Univ. Hosp., Dept. of Neurology	Daegu
Korea, Republic of	Yeungnam Univ. Medical Center, Dept. of Neurology	Daegu
Korea, Republic of	Gachon Medical School Gil Medical Centre, Dept.of Neurology	Incheon
Korea, Republic of	Natl. Health Insurance Corporation Ilsan Hosp., Dept. of Neurology	Koyang
Korea, Republic of	Bundang CHA Hospital, Dept. of Neurology	Seongnam
Korea, Republic of	Kangdong Sacred Heart Hosp., Dept. of Neurology	Seoul
Korea, Republic of	Severance Hospital, Dept. of Neurology	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure Reduction Rate	The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.	Baseline and 16 weeks
Secondary	Seizure Free Rate	The percentage of the participants who experienced no seizure during the trial.	16 weeks
Secondary	Responder Rate	The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.	Baseline and 16 weeks
Secondary	QoL-QOLIE31 (Quality of Life in Epilepsy)	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.	Baseline and 16 weeks