Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Mazandaran University of Medical Sciences103 enrolled

Overview

This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Epilepsy, Idiopathic Generalized

Interventions

LevetiracetamDRUG

Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred

ValproateDRUG

Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age≥16 * At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months * Normal brain MRI or MRI without epileptogenic lesion * Normal electroencephalography(EEG) or existence of generalized epileptiform discharges without any focal epileptiform discharges. * Signing consent form Exclusion Criteria: * History of treatment by sodium valproate or levetiracetam * History of treatment by any anti-epileptic drug in last 6 months * Plan for pregnancy * Using no certain contraceptive method * History of past or current hepatic disease * History of past or current renal disease * History of past or current hematologic disease * History of known psychiatric disease * History of status epilepticus

Locations (1)

Bu Ali Sina Hospital

Sari, Mazandaran, Iran

Outcomes

Primary Outcomes

Time to First Seizure

The time interval from the beginning of the study to occurrence of the first seizure

Time frame: 6 months

Seizure Freedom Rate

Time frame: 6 months

Secondary Outcomes

Withdrawal Rate

Time frame: 6 months

Time to Withdrawal

Time frame: 9 months

Data from ClinicalTrials.gov

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