New onset epilepsy
Conditions
Sponsors
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: 409 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 409 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 409
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: None;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: During the last 28 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Influence of other patient characteristics on dose; Proportion of subjects remaining seizure-free; Time to stabilized dose; Reduction in seizure frequency;Timepoint(s) of evaluation of this end point: Throughout the study duration | — |
Countries
United States
Contacts
Public ContactClinical Registry Group-JB BV
Johnson & Johnson Pharmaceutical Research and Development
Outcome results
None listed