Overview

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Status:
Completed
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mazandaran University of Medical Sciences
Treatments:
Levetiracetam
Valproic Acid
Criteria
Inclusion Criteria:

- Ageā‰„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