FindTrial
Sign In

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03940326
Enrollment
103
Registered
2019-05-07
Start date
2018-04-01
Completion date
2019-12-01
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Idiopathic Generalized

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.

Interventions

DRUGLevetiracetam

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

DRUGValproate

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.

Sponsors

Mazandaran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to First Seizure6 monthsThe time interval from the beginning of the study to occurrence of the first seizure
Seizure Freedom Rate6 months—

Secondary

MeasureTime frame
Withdrawal Rate6 months
Time to Withdrawal9 months

Countries

Iran

Participant flow

Participants by arm

ArmCount
Levetiracetam
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
45
Valproate
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.
58
Total103

Baseline characteristics

CharacteristicLevetiracetamValproateTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
45 Participants58 Participants103 Participants
Age, Continuous26.2 years
STANDARD_DEVIATION 8.1
29 years
STANDARD_DEVIATION 9.7
27.7 years
STANDARD_DEVIATION 9.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
45 Participants58 Participants103 Participants
Region of Enrollment
Iran
45 Participants58 Participants103 Participants
Sex: Female, Male
Female
32 Participants17 Participants49 Participants
Sex: Female, Male
Male
13 Participants41 Participants54 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 450 / 58
other
Total, other adverse events
17 / 4530 / 58
serious
Total, serious adverse events
0 / 452 / 58

Outcome results

Primary

Seizure Freedom Rate

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LevetiracetamSeizure Freedom Rate40 Participants
ValproateSeizure Freedom Rate50 Participants
Primary

Time to First Seizure

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

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
LevetiracetamTime to First Seizure169 DaysStandard Deviation 6.1
ValproateTime to First Seizure178 DaysStandard Deviation 2.2
Secondary

Time to Withdrawal

Time frame: 9 months

ArmMeasureValue (MEAN)Dispersion
LevetiracetamTime to Withdrawal220 DaysStandard Deviation 8.7
ValproateTime to Withdrawal172 DaysStandard Deviation 4.1
Secondary

Withdrawal Rate

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LevetiracetamWithdrawal Rate4 Participants
ValproateWithdrawal Rate6 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026