Data category | Information |
Primary registry and trial identifying number | ClinicalTrials.gov NCT02229123 |
Date of registration in primary registry | 1 September 2014 |
Secondary identifying numbers | EudraCT 2014-000791-26 |
Source of monetary or material support | French Ministry of Health |
Primary sponsor | French Ministry of Health |
Secondary sponsor | European Union’s Seventh Framework Programme for research |
Contact for public queries | GF (email address) |
Contact for scientific queries | GF |
Public title | Levetiracetam efficacy and safety as first-line treatment of neonatal seizures occurring in hypoxic-ischaemic encephalopathy context |
Scientific title | 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 |
Country of recruitment | France |
Health condition(s) or problem(s) studied | Antiepileptic drug, neonatal seizures |
Intervention | Experimental drug: levetiracetam |
Key inclusion and exclusion criteria | Age eligible for study: newborns born after 36 gestational weeks and weighting more than 1800 g at birth |
Inclusion criteria: perinatal asphyxia signs, abnormal neurological examination on the first 6 hours of life; clinical or electrical seizures occurring before 72 hours of life; 8-electrode standard EEG available | |
Exclusion criteria: newborns already treated with an antiepileptic drug, seizures secondary to treatable metabolic abnormalities (ie, hypoglycaemia, hypocalcaemia), serum creatine concentration above 150 µmol/l; congenital malformation or genetic syndrome, proven infectious embryofetopathy, participation to another interventional trial | |
Study type | Interventional |
Allocation: single arm, open study, four increasing dose regimens, two-patient cohort per dose level | |
Primary purpose: optimal-dose finding, efficacy and safety | |
Phase II | |
Date of first enrolment | February 2018 |
Target sample size | 50 |
Recruitment status | Recruiting |
Primary outcomes | Efficacy: seizure-burden reduction of 80% after loading dose on EEG recording |
Safety: short-term and long-term toxicities | |
Key secondary outcomes | Pharmacokinetic analysis through five times (ie, 30 min, 4 hours and 7 hours from the loading dose, 1–3 hours and 12–18 hours from the last maintenance dose) |
Seizure recurrence | |
Pretreatment seizure burden and levetiracetam efficacy |
EEG, electroencephalogram.