Skip to main content
OpenTrials
Completed

NCT Number: NCT03940326

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy, Idiopathic Generalized

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bu Ali Sina Hospital

Sari, Mazandaran, 4815837477, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

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

Other names: Levebel

Valproate

Drug

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.

Primary outcomes

  1. Time to First Seizure

    Time frame: 6 months

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

  2. Seizure Freedom Rate

    Time frame: 6 months

Secondary outcomes

  1. Withdrawal Rate

    Time frame: 6 months

  2. Time to Withdrawal

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Mazandaran University of Medical Sciences

Other

Registry information

Official study title

Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 7, 2019
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.