Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

December 3, 2021 updated by: Nasim Tabrizi, Mazandaran University of Medical Sciences

Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levetiracetam
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
Other Names:
  • Levebel
Active Comparator: Valproate
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Seizure
Time Frame: 6 months
The time interval from the beginning of the study to occurrence of the first seizure
6 months
Seizure Freedom Rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Withdrawal Rate
Time Frame: 6 months
6 months
Time to Withdrawal
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mazandaran University of Medical Sciences

Investigators

  • Principal Investigator: Nasim Tabrizi, MD, Neurology department, Mazandaran University of Medical Sciences, Sari, Iran.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

May 4, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

December 3, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEVIGS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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