Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Phase 4

Completed

• Conditions: Epilepsy, Idiopathic Generalized
• Interventions: Drug: Levetiracetam; Drug: Valproate

• Registration Number: NCT03940326
• Lead Sponsor: Mazandaran University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-04
• Study First Posted: 2019-05-07
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-01
• Results First Submitted: 2021-09-17
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-03
• Last Update Submitted: 2021-12-03
• Results First Posted: 2022-02-17
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	-
Valproate	Valproate	-

Primary Outcome Measures

Name	Time	Method
Seizure Freedom Rate	6 months
Time to First Seizure	6 months	The time interval from the beginning of the study to occurrence of the first seizure

Secondary Outcome Measures

Name	Time	Method
Withdrawal Rate	6 months
Time to Withdrawal	9 months

Trial Locations

Locations (1)

Bu Ali Sina Hospital; 🇮🇷 Sari, Mazandaran, Iran, Islamic Republic of