A comparison of the effectiveness and safety of topiramate and phenytoin in patients with new onset epilepsy requiring rapid initiation of antiepileptic drug treatment
- Conditions
- ew onset epilepsyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-001222-42-Outside-EU/EEA
- Lead Sponsor
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 261
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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