Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

NCT ID: NCT03940326

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-12-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levetiracetam

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: 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

Valproate

Group Type: ACTIVE_COMPARATOR

Valproate

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Levebel

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mazandaran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Nasim Tabrizi

Assistant professor of neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nasim Tabrizi, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology department, Mazandaran University of Medical Sciences, Sari, Iran.

Locations

Bu Ali Sina Hospital

Sari, Mazandaran, Iran

Countries

Iran

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LEVIGS

Identifier Type: -

Identifier Source: org_study_id