Phase 4 N=103 Treatment

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Epilepsy, Idiopathic Generalized

Bottom Line

View on ClinicalTrials.gov: NCT03940326 ↗

Enrolled (actual)

103

Serious AEs

1.9%

Results posted

Feb 2022

Primary outcome: Primary: Time to First Seizure — 169; 178 Days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Levetiracetam (Drug); Valproate (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Mazandaran University of Medical Sciences
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Seizure	169; 178	—
PRIMARY Seizure Freedom Rate	40; 50	—
SECONDARY Withdrawal Rate	4; 6	—
SECONDARY Time to Withdrawal	220; 172	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03940326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.