A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy
The purpose of this study is to compare the safety and effectiveness of two doses of topiramate as monotherapy in the treatment of pediatric and adult patients with newly diagnosed or recurrent epilepsy.
Topiramate is approved for treating epilepsy in combination with other epilepsy drugs, but not approved for treating epilepsy as sole treatment or in recently diagnosed epilepsy characterized by partial-onset seizures. This is a randomized, double-blind, parallel-group, multicenter study to compare the safety and effectiveness of two doses of topiramate as monotherapy in pediatric and adult patients with newly diagnosed (within 3 months) or recurrent epilepsy (partial-onset or primary generalized tonic-clonic). The study consists of 4 phases: Baseline (assessment of seizure frequency and other eligibility), Open-Treatment (all patients receive 25 milligrams[mg]/day of topiramate for 7 days), Core Double-Blind Phase (patients are randomized to receive either their assigned dose of topiramate of 50mg/day or 400mg/day, or maximum tolerated dose, and then remain, if possible, on that dose for the duration of the double-blind phase; they continue to receive the medication until they experience the first seizure or until 6 months after the last patient is enrolled), and Long-Term Extension Phase (patients continue to receive the medication at maximum tolerated dose, which may be adjusted according to individual tolerability and effectiveness, until either the patient withdraws or the sponsor terminates the study). The study hypothesis is that topiramate will be effective in the treatment of newly diagnosed or recurrent epilepsy in dose-dependent manner. Topiramate tablets (25 milligrams[mg]) daily by mouth in once-daily regimen during the 7-day Open-Treatment Phase; topiramate twice daily for total of 50mg/day or 400mg/day during the Double-Blind Phase.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00231556
- 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)
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)
An anticonvulsant effective in tonic-clonic epilepsy (EPILEPSY, TONIC-CLONIC). It may cause blood dyscrasias.
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)
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)
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