drugset / Trial / NCT02229123
Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study
Phase 2
Completed
18 enrolled
University Hospital, Tours
Amiens University Hospital · collabAssistance Publique - Hôpitaux de Paris · collabRennes University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam as first line treatment in term newborn babies with seizures in hypoxic-ischemic encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures in newborns.
Timeline
- Start
- 2018-02-27
- Primary completion
- 2022-02-23
- Completion
- 2022-02-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levetiracetam | Other / unclassified | 7.5 mg/kg | Intravenous |
| Subject | Levetiracetam | Other / unclassified | 10 mg/kg | Intravenous |
| Subject | Levetiracetam | Other / unclassified | 12.5 mg/kg | Intravenous |