Epilepsy, Idiopathic Generalized Clinical Trial
Official title:
Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures
Verified date | December 2021 |
Source | Mazandaran University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Bu Ali Sina Hospital | Sari | Mazandaran |
Lead Sponsor | Collaborator |
---|---|
Mazandaran University of Medical Sciences |
Iran, Islamic Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06388174 -
Idiopathic Generalized Epilepsy Syndromes
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