A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy

Conditions: ew onset epilepsy
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2015-001223-23-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: 409

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

- 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 & 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 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 Outcome Measures

Name	Time	Method
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