A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy
Summary
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.
Description
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.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Epilepsy
Intervention
Topiramate
Status
Completed
Source
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00266604
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Myoclonic Epilepsy, Juvenile
A disorder characterized by the onset of myoclonus in adolescence, a marked increase in the incidence of absence seizures (see EPILEPSY, ABSENCE), and generalized major motor seizures (see EPILEPSY, TONIC-CLONIC). The myoclonic episodes tend to occur shortly after awakening. Seizures tend to be aggravated by sleep deprivation and alcohol consumption. Hereditary and sporadic forms have been identified. (From Adams et al., Principles of Neurology, 6th ed, p323)
Epilepsy
A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)
Mephenytoin
An anticonvulsant effective in tonic-clonic epilepsy (EPILEPSY, TONIC-CLONIC). It may cause blood dyscrasias.
Epilepsy, Rolandic
An autosomal dominant inherited partial epilepsy syndrome with onset between age 3 and 13 years. Seizures are characterized by PARESTHESIA and tonic or clonic activity of the lower face associated with drooling and dysarthria. In most cases, affected children are neurologically and developmentally normal. (From Epilepsia 1998 39;Suppl 4:S32-S41)
Epilepsy, Reflex
A subtype of epilepsy characterized by seizures that are consistently provoked by a certain specific stimulus. Auditory, visual, and somatosensory stimuli as well as the acts of writing, reading, eating, and decision making are examples of events or activities that may induce seizure activity in affected individuals. (From Neurol Clin 1994 Feb;12(1):57-8)
Clinical Trials
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A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Epilepsy.
The purpose of this study is to evaluate the effectiveness and safety of topiramate as an add-on therapy in patients with uncontrolled partial onset seizures who are taking one or two stan...
A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)
This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy.
The purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy
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PubMed Articles
It is well known that oxidative stress plays an important role in the etiology of epilepsy. We investigated effects of selenium (Se) and topiramate (TPM) combination supplementation on antioxidant and...
Topiramate dose effects on cognition: A randomized double-blind study.
Topiramate (TPM), a broad-spectrum antiepileptic drug, has been associated with neuropsychological impairment in patients with epilepsy and in healthy volunteers.
A fatal intoxication case involving topiramate.
Topiramate belongs to a new group of anticonvulsive drugs primarily applied in treatment of epilepsy and in preventive therapy of migraines. Topiramate is structurally unrelated to other antiepileptic...
Topiramate and temporal lobe epilepsy: an open-label study.
Purpose. To evaluate the efficacy and tolerability of topiramate (TPM) as monotherapy for patients with temporal lobe epileptic seizures based on an observational study. Methods. We evaluated 41 pati...
Antioxidant activity of topiramate: an antiepileptic agent.
A number of experimental and clinical reports suggest the involvement of oxidative stress in pathophysiology of epilepsy. Topiramate, a new antiepileptic drug, induces antioxidant effect in epileptic...
