Levetiracetam Versus Valproate in Idiopathic Generalized Epilepsy (LEVAGE)

April 30, 2024 updated by: Nasim Tabrizi, Mazandaran University of Medical Sciences

Investigation of Long-term Outcome of Levetiracetam and Valproate in Treatment of Idiopathic Generalized Epilepsy

This study aimed to compare the long-term efficacy and safety of levetiracetam and valproate in treatment of idiopathic generalized epilepsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

169

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients with idiopathic generalized epilepsy (juvenile myoclonic epilepsy or generalized tonic-clonic seizure alone) who are on monotherapy with levetiracetam or sodium valproate

Description

Inclusion Criteria:

  • Diagnosis of juvenile myoclonic epilepsy or generalized tonic-clonic seizure alone
  • Regular monotherapy with levetiracetam or sodium valproate

Exclusion Criteria:

  • Poor drug adherence
  • Pregnancy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Levetiracetam
Patients with idiopathic generalized epilepsy who were under treatment with levetiracetam
Drug: Levetiracetam
Patients with idiopathic generalized epilepsy who were under treatment with levetiracetam
Sodium valproate
Patients with idiopathic generalized epilepsy who were under treatment with valproate
Drug: Sodium valproate
Patients with idiopathic generalized epilepsy who were under treatment with valproate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure free rate
Time Frame: 1 to 5 years
The percent of patients who remained seizure free on treatment
1 to 5 years
Time to first seizure
Time Frame: 1 to 5 years
The interval between start of treatment and recurrence of seizure
1 to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rate
Time Frame: 1 to 5 years
The percent of patients who remained on treatment with levetiracetam or valproate
1 to 5 years
Time to withdrawal
Time Frame: 1 to 5 years
The interval between start and withdrawal of treatment
1 to 5 years

Collaborators and Investigators

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

Sponsor

Mazandaran University of Medical Sciences

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)

September 3, 2022

Primary Completion (Actual)

March 19, 2024

Study Completion (Actual)

March 19, 2024

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14751

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

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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