A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy
A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy
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.
Any number of factors could affect the dosage needs for an anti-epileptic medication,
 however, various lines of evidence suggest that characteristics of the patient's epilepsy
 itself could be important determinants. Baseline (i.e., at the start of the study) patient
 characteristics, particularly seizure frequency, may predict dosage needs when TOPAMAX®
 (topiramate) is initiated as monotherapy and titrated to an individualized optimal dose.
 Topiramate is an anti-epileptic drug that is approved for epilepsy either alone (i.e.,
 monotherapy), or in combination with other anti-epileptic medications, in adults and children
 2 years of age and above. This is a multicenter, outpatient, open-label, single-arm study to
 evaluate the dosing, tolerability, effectiveness and safety of topiramate as initial therapy
 for epilepsy in clinical practice. Patients who have been identified by their physicians as
 candidates for initial anti-epileptic monotherapy will be enrolled. Patients will begin
 therapy with topiramate tablets starting at 50 milligrams per day and be titrated to an
 individualized optimal dose, up to a maximum of 400 milligrams per day, by the end of week 6.
 Changes to this schedule will be based on a risk-benefit assessment of the patient's clinical
 condition by the investigator, such as tolerability, or reaching a stable dose sufficient to
 control their seizures. Treatment with topiramate will last for a total of 24 weeks. The
 primary outcome of the study is a comparison of the mean stabilized topiramate dose during
 the last 28 days of treatment for patients reporting 1 to 3 seizures during the 3 months
 prior to study entry versus patients reporting more than 3 seizures during the 3 months prior
 to study entry. The study hypothesis is that the average stabilized dose of topiramate will
 be lower in patients that have had fewer seizures in the 3 months prior to beginning the
 study. Topiramate tablets starting at 50 milligrams per day and titrated to an individualized
 optimal dose, up to a maximum of 400 milligrams per day by the end of week 6. Patients will
 take topiramate tablets by mouth twice a day (morning and evening) for 24 weeks.
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