NCT00210574

CompletedPhase 2

A Pilot Study of Topiramate in Childhood Absence Epilepsy

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

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Other study identifiers

Sponsor study identifier

CR002872

Study Type

interventional

Actual enrollment (reported)

12

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 2006

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 12 participants
Study completion date: October 2006
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)
Study Completion
October 2006
Actual (reported)

Last Updated: June 10, 2011
Status Verified: April 2010
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Ortho-McNeil Neurologics, Inc.
Industrycollaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industrylead

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)

Fructose

Study Officials

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
STUDY DIRECTOR

Enrollment

12 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

Completed

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Phase 2Completed

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Phase 2Completed

NCT00236691

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NCT00231608

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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.

Hexoses

Monosaccharides

Sugars

Carbohydrates

Ketoses

Study Completion

October 2006

Actual (reported)

Last Updated

June 10, 2011

Record last verified: 2010-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00210574
Data provider: ClinicalTrials.gov
Source updated: 2011-06-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:43 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record