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Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Primary Purpose

Epilepsy, Idiopathic Generalized

Status

Completed

Phase

Phase 4

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Levetiracetam

Valproate

About this trial

This is an interventional treatment trial for Epilepsy, Idiopathic Generalized

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Bu Ali Sina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levetiracetam

Valproate

Arm Description

Outcomes

Primary Outcome Measures

Time to First Seizure

The time interval from the beginning of the study to occurrence of the first seizure

Seizure Freedom Rate

Secondary Outcome Measures

Withdrawal Rate

Time to Withdrawal

Full Information

NCT ID

NCT03940326

First Posted

April 30, 2019

Last Updated

December 3, 2021

Sponsor

Mazandaran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03940326

Brief Title

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

October 1, 2019 (Actual)

Study Completion Date

December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mazandaran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Idiopathic Generalized

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levetiracetam

Arm Type

Experimental

Arm Title

Valproate

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Levetiracetam

Other Intervention Name(s)

Levebel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Valproate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to First Seizure

Description

The time interval from the beginning of the study to occurrence of the first seizure

Time Frame

6 months

Title

Seizure Freedom Rate

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Withdrawal Rate

Time Frame

6 months

Title

Time to Withdrawal

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nasim Tabrizi, MD

Organizational Affiliation

Neurology department, Mazandaran University of Medical Sciences, Sari, Iran.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bu Ali Sina Hospital

City

Sari

State/Province

Mazandaran

ZIP/Postal Code

4815837477

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

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