NCT01127256

Brief Summary

The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2006

Typical duration for phase_4

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 26, 2012

Completed
Last Updated

January 4, 2022

Status Verified

May 1, 2010

Enrollment Period

3 years

First QC Date

May 19, 2010

Results QC Date

August 2, 2010

Last Update Submit

December 10, 2021

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Participants With Seizure Free Rate

    The percentage of participants who had no seizure during the trial.

    24 weeks

Secondary Outcomes (2)

  • The Percentage of Participants With Retention Rate

    24 weeks

  • Quality of Life in Epilepsy (QoL-QOLIE31)

    24 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: zonisamide

2

ACTIVE COMPARATOR
Drug: carbamazepine

Interventions

zonisamideDRUG

Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.

1
carbamazepineDRUG

Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.

2

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Epilepsy patients over 15 years old.
  • Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
  • Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
  • Female who can be in the month of pregnancy should agree to prevent conception.
  • Patients who agree with Informed Consent Form.

You may not qualify if:

  • Patients who have Myoclonic seizures and/or Absence seizures.
  • Patients who have progressive central nervous system (CNS) disorder.
  • Patients who have serious systemic disorder.
  • Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.
  • Patients who have renal stones.
  • Medical history of medicinal poisoning and/or alcoholism.
  • Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Seoul National Univ. Bundang Hosp.

Bundang, South Korea

Location

Dongguk Univ. Ilsan Hosp.

Ilsan, South Korea

Location

Inha Univ. Hosp.

Incheon, South Korea

Location

Chungnam National Univ. Hosp.

Jungnam, South Korea

Location

Boramae Medical Center

Seoul, South Korea

Location

Eulji General Hosp.

Seoul, South Korea

Location

Ewha Womans Univ. Mokdong Hospital

Seoul, South Korea

Location

Hallym Univ. Medical Center

Seoul, South Korea

Location

Hanyang Univ. Medical Center

Seoul, South Korea

Location

Konkuk Univ. Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National Univ. Hosp.

Seoul, South Korea

Location

MeSH Terms

Conditions

Epilepsy

Interventions

ZonisamideCarbamazepine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 20, 2010

Study Start

May 31, 2006

Primary Completion

May 31, 2009

Study Completion

July 31, 2009

Last Updated

January 4, 2022

Results First Posted

July 26, 2012

Record last verified: 2010-05

Locations

KR(12)