CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 103 enrolled
Drug / intervention
Levetiracetam +1 moredrug
Likely dose
Levetiracetam 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03940326
NCT03940326Phase 4Completed
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Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures

Mazandaran University of Medical Sciences·interventional·Posted May 7, 2019·Updated Feb 17, 2022

In Brief

A Phase 4 clinical trial evaluating Levetiracetam and Valproate for Epilepsy, Idiopathic Generalized. Completed, enrolled 103 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Idiopathic Generalized
CountriesIran
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 7, 2019
Enrollment StartApr 1, 2018
Primary CompletionOct 1, 2019
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.2 years ago

Interventions

Levetiracetamdrug

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

Valproatedrug

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.