Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures
Paraules clau
Resum
Dates
| Darrera verificació: | 04/30/2019 |
| Primer enviat: | 04/29/2019 |
| Inscripció estimada enviada: | 05/03/2019 |
| Publicat per primera vegada: | 05/06/2019 |
| Última actualització enviada: | 05/03/2019 |
| Publicació de l'última actualització: | 05/06/2019 |
| Data d'inici de l'estudi real: | 03/31/2018 |
| Data estimada de finalització primària: | 09/30/2019 |
| Data estimada de finalització de l’estudi: | 11/30/2019 |
Condició o malaltia
Intervenció / tractament
Drug: Levetiracetam
Drug: Valproate
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Levetiracetam | 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 |
| Active Comparator: Valproate | Drug: 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. |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 16 Years Per a 16 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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 |
Resultat
Mesures de resultats primaris
1. Time to first seizure [1 year]
2. Seizure freedom rate [1 year]
Mesures de resultats secundaris
1. Withdrawal rate [1 year]
2. Time to withdrawal [1 year]
