Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

NCT03940326 | Completed Phase 4 Results

• 1 other identifier: LEVIGS
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Idiopathic Generalized

Outcome Measures

Primary Outcomes (2)

• Time to First Seizure

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

  6 months

• Seizure Freedom Rate

  6 months

Secondary Outcomes (2)

• Withdrawal Rate

  6 months

• Time to Withdrawal

  9 months

Study Arms (2)

Levetiracetam

EXPERIMENTAL

Drug: Levetiracetam

Valproate

ACTIVE COMPARATOR

Drug: Valproate

Interventions

Levetiracetam DRUG

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

Also known as: Levebel

Levetiracetam

Valproate DRUG

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.

Valproate

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Bu Ali Sina Hospital

Sari, Mazandaran, 4815837477, Iran

Location

MeSH Terms

Conditions

Epilepsy, Idiopathic Generalized

Interventions

Levetiracetam; Valproic Acid

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Fatty Acids, Volatile; Fatty Acids; Lipids

Limitations and Caveats

1. The decision to choose between two arms of the study was made based on clinicians' judgment and we could not randomized or blind the study. 2. The current results are based on a 6-month follow up of patients and the results in longer follow up periods might be different. 3. The low number of patients might decrease the power of this study.

Results Point of Contact

• Title: Nasim Tabrizi
• Organization: Mazandaran University of medical sciences

nasimtabrizi@gmail.com

+981133343015

Study Officials

• Nasim Tabrizi, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of neurology

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 7, 2019
• Study Start: April 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 17, 2022
• Results First Posted: February 17, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)