Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Epilepsy, Idiopathic Generalized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940326
• Other study ID #: LEVIGS
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2021
• Source: Mazandaran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy, Idiopathic Generalized
• Seizures

Intervention

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
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Bu Ali Sina Hospital	Sari	Mazandaran

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Seizure	The time interval from the beginning of the study to occurrence of the first seizure	6 months
Primary	Seizure Freedom Rate		6 months
Secondary	Withdrawal Rate		6 months
Secondary	Time to Withdrawal		9 months