MedTrace Logo

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

NCT03940326 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2022-02-17

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Epilepsy, Idiopathic Generalized

Interventions

DRUG

Levetiracetam

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

DRUG

Valproate

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.

Sponsors & Collaborators

  • Mazandaran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Nasim Tabrizi, MD · Neurology department, Mazandaran University of Medical Sciences, Sari, Iran.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-10-01
Completion
2019-12-01

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940326 on ClinicalTrials.gov