NCT00216567

Brief Summary

The purpose of this study is to determine the efficacy and safety of Topiramate in comparison to Carbamazepine in Benign rolandic epilepsy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2002

Typical duration for phase_4

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

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

First QC Date

September 13, 2005

Last Update Submit

January 31, 2011

Conditions

Epilepsy, Rolandic

Keywords

Benign rolandic epilepsyTopiramate

Outcome Measures

Primary Outcomes (1)

  • Seizure-free rate at 24 weeks in comparison of topiramate to carbamazepine

Secondary Outcomes (1)

  • In comparison of topiramate to carbamazepine, Intellectual Functioning : KEDI-WISC (Korean Educational Development Institute Wechsler Intelligence Scale for Children-Revised)

Interventions

topamaxDRUG

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects whose guardians submitted written consent
  • Subjects with more than 2 seizures in last 1 year
  • Subjects showing one of the following additional criteria
  • Psychological burden due to seizure
  • Seizure in daytime
  • More than 3 seizures in last 6 month
  • Convulsive seizure

You may not qualify if:

  • Abnormalities on MRI, EEG
  • Mental retardation
  • History of seizure relapse
  • Seizures due to organic causes
  • Medically serious acute or chronic disease or progressive and degenerative disorders
  • Patients who have received an investigational medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy, Rolandic

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Epilepsies, PartialEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Janssen Korea, Ltd. Clinical Trial

    Janssen Korea, Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

December 1, 2002

Study Completion

February 1, 2006

Last Updated

February 1, 2011

Record last verified: 2011-01