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

NCT01140867 | Completed Phase 4 Results

• 1 other identifier: E2090-S082-409
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Seizure Reduction Rate

  The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.

  Baseline and 16 weeks

Secondary Outcomes (3)

• Seizure Free Rate

  16 weeks

• Responder Rate

  Baseline and 16 weeks

• QoL-QOLIE31 (Quality of Life in Epilepsy)

  Baseline and 16 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: zonisamide

Interventions

zonisamide DRUG

zonisamide 100 mg tablet

1

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
• Patient who experiences pseudoseizures and/or who has uncountable clusters.
• Patient who has serious systemic or drug metabolism affecting disorder .
• Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.
• Patient who has absolute neutrophil counts \<1800/mm3 or platelets \<100,000/mm3.
• Patient who has medical history of renal stones.
• Patient who is allergic to sulfonamide.
• Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.
• Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.
• A terminal patient and/or a scheduled surgical patient.
• Patient who has medication history of zonisamide.
• Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (10)

Dong-A University Hospital, Dept. of Neurology

Busan, South Korea

Location

Inje Univ. Pusan Paik Hospital, Dept. of Neurology

Busan, South Korea

Location

Keimyung Univ.Dongsan Medical Centre, Dept. of Neurology

Daegu, South Korea

Location

Kyungpook Natl. Univ. Hosp., Dept. of Neurology

Daegu, South Korea

Location

Yeungnam Univ. Medical Center, Dept. of Neurology

Daegu, South Korea

Location

Gachon Medical School Gil Medical Centre, Dept.of Neurology

Incheon, South Korea

Location

Natl. Health Insurance Corporation Ilsan Hosp., Dept. of Neurology

Koyang, South Korea

Location

Bundang CHA Hospital, Dept. of Neurology

Seongnam, South Korea

Location

Kangdong Sacred Heart Hosp., Dept. of Neurology

Seoul, South Korea

Location

Severance Hospital, Dept. of Neurology

Seoul, South Korea

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jihee Mun, Pharmacist, Medical Department manager
• Organization: Eisai Korea Inc.

jihee_mun@eisaikorea.com

+82-2-3451-5531

Study Officials

• Jihee Mun

  Medical Department, Eisai Korea Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: June 10, 2010
• Study Start: February 29, 2008
• Primary Completion: August 31, 2010
• Study Completion: March 31, 2011
• Last Updated: January 4, 2022
• Results First Posted: September 8, 2011

Record last verified: 2011-05

Locations

KR (10)