NCT00266604

Brief Summary

The purpose of this study is to identify patient characteristics (such as baseline seizure frequency) that may predict effective doses of topiramate using just that one drug (monotherapy) as initial therapy for epilepsy. Topiramate is an anti-epileptic drug that is approved for the treatment of epilepsy in adults and children 2 years of age and above.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
409

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 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

December 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

First QC Date

December 16, 2005

Last Update Submit

June 8, 2011

Conditions

EpilepsySeizuresEpilepsies, PartialEpilepsy, GeneralizedSeizures, Tonic-Clonic

Keywords

Epilepsyseizuresnew-onset epilepsyepilepsy relapseepilepsy monotherapy

Outcome Measures

Primary Outcomes (1)

  • Comparison of the mean stabilized topiramate dose during the last 28 days of treatment between patients reporting 1 to 3 seizures versus patients reporting more than 3 seizures, during the 3 months prior to study entry

Secondary Outcomes (1)

  • Influence of other patient characteristics on dose; Proportion of subjects remaining seizure-free; Time to stabilized dose; Reduction in seizure frequency

Interventions

TopiramateDRUG

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having new-onset epilepsy or epilepsy relapse characterized by partial-onset seizures or primary generalized tonic-clonic seizures
  • having at least 1 seizure within the 3 months prior to entry
  • who are previously untreated for epilepsy, previously treated for epilepsy, or if currently taking epilepsy medication, must have been taking it for less than 6 weeks
  • weighing at least 25 kilograms (approximately 55 pounds)
  • if female of childbearing potential, must be using an acceptable method of birth control

You may not qualify if:

  • Patients who have previously taken topiramate for the treatment of epilepsy
  • who are currently taking topiramate for any reason
  • having active liver disease
  • having a clinically significant medical condition or disease
  • women who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

EpilepsySeizuresEpilepsies, PartialEpilepsy, Generalized

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic 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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 16, 2005

First Posted

December 19, 2005

Study Start

December 1, 2005

Study Completion

June 1, 2007

Last Updated

June 10, 2011

Record last verified: 2010-04