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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03940326
Other study ID # LEVIGS
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06388174 - Idiopathic Generalized Epilepsy Syndromes