NCT03940326

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Mazandaran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-10-01
• Completion: 2019-12-01
• First posted: 2019-05-07
• Last updated: 2022-02-17
• Results posted: 2022-02-17

Locations

1 site across 1 country: Iran