Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Mazandaran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Epilepsy, Idiopathic Generalized

Treatments: Drug: Valproate; Drug: Levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT03940326

LEVIGS

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Levetiracetam

Experimental group

Treatment:

Drug: Levetiracetam

Valproate

Active Comparator group

Treatment:

Drug: Valproate