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Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

2014-07-23 21:09:01 | BioPortfolio

Summary

The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

Description

To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25~27 weeks.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Epilepsy

Intervention

zonisamide, carbamazepine

Location

Seoul National Univ. Bundang Hosp.
Bundang
Korea, Republic of

Status

Completed

Source

Eisai Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:01-0400

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Medical and Biotech [MESH] Definitions

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)

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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)

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Epilepsy is defined as a disorder of brain function characterized by recurrent seizures that have a sudden onset.  (Oxford Medical Dictionary).  A seizure is caused by a sudden burst of excess electrical activity in the brain, causing a tempora...


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