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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier:
NCT01140867
First received: May 19, 2010
Last updated: September 8, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Epilepsy
Drug: zonisamide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Seizure Reduction Rate [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.


Secondary Outcome Measures:
  • Seizure Free Rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The percentage of the participants who experienced no seizure during the trial.

  • Responder Rate [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 121
Study Start Date: February 2008
Study Completion Date: March 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: zonisamide
zonisamide 100 mg tablet

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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140867

Locations
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, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.
Investigators
Study Director: Jihee Mun Medical Department, Eisai Korea Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier: NCT01140867     History of Changes
Other Study ID Numbers: E2090-S082-409
Study First Received: May 19, 2010
Results First Received: August 5, 2011
Last Updated: September 8, 2011
Health Authority: KFDA: Korea

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zonisamide
Anticonvulsants
Antioxidants
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014