Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study
NCT ID: NCT02229123
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2018-02-27
2022-02-23
Brief Summary
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Detailed Description
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* The principal aim of LEVNEONAT-1 is to determine the levetiracetam optimal dose defined as the highest efficient dose under toxicity restrictions for treating neonatal seizures.
* LEVNEONAT-1 is an open-label, sequential dose-finding study with 3 increasing dose levels of levetiracetam.
Strenghts and limitation of study
* For the first time, levetiracetam will be used as the first-line treatment of neonatal seizures and not as an add-on therapy.
* Statistical model is designed for a rare clinical situation with a sequential adaptive method updating in real time the dose allocation for next patient by using all available data from previous participants.
* The targeted population, i.e. the newborn less than 3 days of life, is particularly sensitive and the written consent of both parents is required before the levetiracetam administration.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravenous levetiracetam
1 loading dose of 30, 40 or 50 mg/kg administered intra-venously. Maintenance treatment: one intra-venous injection /8h, 8 doses in total for a 3-day treatment. Maintenance dose corresponds to the loading dose quarter i.e. 7.5, 10 or 12.5 mg/kg.
Intravenous Levetiracetam
Open-study. If seizure lasting more than 3 minutes on EEG recording or brief repeated seizures (more or equal to 2 seizures lasting more than 20 seconds on a 1 hour-interval), the loading-dose of LEV allocated to patient is infused followed by the 8 maintenance dose.
Interventions
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Intravenous Levetiracetam
Open-study. If seizure lasting more than 3 minutes on EEG recording or brief repeated seizures (more or equal to 2 seizures lasting more than 20 seconds on a 1 hour-interval), the loading-dose of LEV allocated to patient is infused followed by the 8 maintenance dose.
Eligibility Criteria
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Inclusion Criteria
* Availability of 8 electrode EEG recording
* Written informed consent of both parents or the authorized guardians
* Subscription to social security health insurance are required
Exclusion Criteria
* Congenital (in utero) infection (TORCH)
* Babies who have received phenobarbital or any other anticonvulsive medication other than a bolus of midazolam for intubation
* Anuria/renal failure defined as serum creatinine \> 150 micromol/L
* Seizures secondary to treatable metabolic etiology as hypoglycemia and hypocalcemia
* Corrected QT interval (QTc) greater than 450 milliseconds on the electrocardiogram (ECG) prior to inclusion in the presence or absence of a condition that promotes QT prolongation (hypokalemia, maternal treatment during childbirth or treatment of the child with drugs known to prolong QT),
* Participation to an interventional research study
36 Weeks
43 Weeks
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Rennes University Hospital
OTHER
Amiens University Hospital
OTHER
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Geraldine Favrais, Dr
Role: STUDY_CHAIR
University Hospital of Tours
Geraldine FAVRAIS, Dr
Role: PRINCIPAL_INVESTIGATOR
University hospital of Tours
Locations
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Service de réanimation néonatale
Angers, , France
Service de réanimation néonatale
Lille, , France
Service de réanimation et service néonatale
Orléans, , France
Service de réanimation néonatale et pédiatrique
Paris, , France
Service de réanimation néonatale
Reims, , France
Néonatologie
Rennes, , France
Service de Pédiatrie néonatale et réanimation
Rouen, , France
Service de Néonatologie
Tours, , France
Countries
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References
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Favrais G, Ursino M, Mouchel C, Boivin E, Jullien V, Zohar S, Saliba E. Levetiracetam optimal dose-finding as first-line treatment for neonatal seizures occurring in the context of hypoxic-ischaemic encephalopathy (LEVNEONAT-1): study protocol of a phase II trial. BMJ Open. 2019 Jan 24;9(1):e022739. doi: 10.1136/bmjopen-2018-022739.
Other Identifiers
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2014-000791-26
Identifier Type: -
Identifier Source: org_study_id