New onset epilepsy
Conditions
Sponsors
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Seizures indicative of new-onset epilepsy (or epilepsy relapse) of untreated epilepsy - at least one but not more than 20 unprovoked seizures within past 3 months - weighing more than 110 pounds - considered to be a good candidate for rapid initiation of anti-seizure medication - able to swallow a tablet whole (without crushing it). Are the trial subjects under 18? yes Number of subjects for this age range: 262 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 262 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 262
Exclusion criteria
Exclusion criteria: - Not having taken anti-seizure medications within the past 30 days - no provoking factors for seizures (presence of alcohol withdrawal, drug intoxication, acute meningitis or encephalitis, acute head injury or stroke, acute hypoxic/ischemic encephalopathy, or brain tumor) - no presence of active liver disease or serious kidney disease - not pregnant or breast-feeding - not using birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to compare the effectiveness and safety of two treatment regimens, topiramate as compared to phenytoin, in preventing seizures in patients with new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug to an effective dose, may include severe or frequent seizures, or high risk to the patient of recurrent seizures.;Secondary Objective: None;Primary end point(s): The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.;Timepoint(s) of evaluation of this end point: Throughout the study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effect of sex, age, baseline weight, baseline seizure type, and duration since first diagnosis of epilepsy on the time to seizure.;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