NCT00210574

Brief Summary

Limited data exist on the effectiveness of antiepileptic drugs for treatment of childhood absence epilepsy. Preliminary data suggest that topiramate may be an effective drug for this condition. The present study is designed to provide further evidence of the potential effectiveness of topiramate for childhood absence epilepsy, as well as preliminary information about a potential target dose for future study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2005

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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

First QC Date

September 13, 2005

Last Update Submit

June 8, 2011

Conditions

Epilepsy, Absence

Keywords

childhood absence epilepsyepilepsyseizuresabsence seizures

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who become seizure-free.

Secondary Outcomes (1)

  • Change in number of seizures per hour; change in duration of EEG spike wave discharges per hour; relationship between the lack of seizures and the blood level of topiramate.

Interventions

topiramateDRUG

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Weight of at least 15 kg (33 pounds)
  • confirmed diagnosis of childhood absence epilepsy
  • no other serious health problems or neurologic problems
  • have not taken anti-epilepsy drugs other than ethosuximide, lamotrigine, or valproate
  • able to take oral medication in a sprinkle capsule formulation
  • girls must not have gotten their first menstrual period.

You may not qualify if:

  • No seizures that are caused by something other than childhood absence epilepsy
  • not taken topiramate, primidone, zonisamide, or phenobarbital in the past
  • had to stop taking an anti-epilepsy drug (ethosuximide, lamotrigine, or valproate) because it was not effective in treating childhood absence epilepsy
  • no presence of abnormal brain waves on electroencephalogram
  • no presence of mental retardation, no autism, or severe developmental disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Epilepsy, AbsenceEpilepsySeizures

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic SyndromesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2005

Study Completion

October 1, 2006

Last Updated

June 10, 2011

Record last verified: 2010-04