Epilepsy Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 409 |
Est. completion date | June 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Ortho-McNeil Neurologics, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Influence of other patient characteristics on dose; Proportion of subjects remaining seizure-free; Time to stabilized dose; Reduction in seizure frequency |
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