- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00266604
A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy
June 8, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
TOPAMAX� (Topiramate) Initiated as Monotherapy in Epilepsy (TIME): A Multicenter, Outpatient, Open-Label, Study to Evaluate the Dosing, Effectiveness and Safety of TOPAMAX� as Monotherapy in the Treatment of Epilepsy in Clinical Practice
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Any number of factors could affect the dosage needs for an anti-epileptic medication, however, various lines of evidence suggest that characteristics of the patient's epilepsy itself could be important determinants.
Baseline (i.e., at the start of the study) patient characteristics, particularly seizure frequency, may predict dosage needs when TOPAMAX® (topiramate) is initiated as monotherapy and titrated to an individualized optimal dose.
Topiramate is an anti-epileptic drug that is approved for epilepsy either alone (i.e., monotherapy), or in combination with other anti-epileptic medications, in adults and children 2 years of age and above.
This is a multicenter, outpatient, open-label, single-arm study to evaluate the dosing, tolerability, effectiveness and safety of topiramate as initial therapy for epilepsy in clinical practice.
Patients who have been identified by their physicians as candidates for initial anti-epileptic monotherapy will be enrolled.
Patients will begin therapy with topiramate tablets starting at 50 milligrams per day and be titrated to an individualized optimal dose, up to a maximum of 400 milligrams per day, by the end of week 6.
Changes to this schedule will be based on a risk-benefit assessment of the patient's clinical condition by the investigator, such as tolerability, or reaching a stable dose sufficient to control their seizures.
Treatment with topiramate will last for a total of 24 weeks.
The primary outcome of the study is a comparison of the mean stabilized topiramate dose during the last 28 days of treatment for patients reporting 1 to 3 seizures during the 3 months prior to study entry versus patients reporting more than 3 seizures during the 3 months prior to study entry.
The study hypothesis is that the average stabilized dose of topiramate will be lower in patients that have had fewer seizures in the 3 months prior to beginning the study.
Topiramate tablets starting at 50 milligrams per day and titrated to an individualized optimal dose, up to a maximum of 400 milligrams per day by the end of week 6.
Patients will take topiramate tablets by mouth twice a day (morning and evening) for 24 weeks.
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Outcome Measures
Outcome Measure |
---|
Influence of other patient characteristics on dose; Proportion of subjects remaining seizure-free; Time to stabilized dose; Reduction in seizure frequency
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
December 16, 2005
First Submitted That Met QC Criteria
December 16, 2005
First Posted (Estimate)
December 19, 2005
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR002869
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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