A Phase 1/2 interventional study of Oral levetiracetam and Intravenous phenobarbital in Neonatal Seizures, sponsored by Children's Hospital of Fudan University. Terminated at 1 site in China. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Children's Hospital of Fudan University · Phase 1/2, Interventional, and Treatment
Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The purpose of this study is to determine the correct oral dosing, safety and efficacy for oral Levetiracetam as first line treatment in term new born babies with seizures.
This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects. Levetiracetam has great potential as a treatment for neonatal seizures but is not approved for use in children less than 1 years of age by oral. This study aims to obtain essential data regarding the efficacy and safety of oral Levetiracetam in neonatal population and simultaneously to use EEG monitoring systems that facilitate seizure detection and research.
Specific aims are:
881 studies on the registry are indexed under Seizures; 144 are open to participants now.
This study's enrollment of 60 is close to the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Neonatal seizure occurred and was proved by EEG according to abnormal discharge of brain. one or more of the following :
Exclusion Criteria:
Oral levetiracetam 50 mg/kg loading dose. 10 mg/kg 8 hourly maintenance
Drug: Oral levetiracetam
Intravenous phenobarbital 20 loading dose (add to 40 mg/kg if seizure discontrol). 5 mg/kg 24 hourly maintenance
Drug: Intravenous phenobarbital
Oral load of levetiracetam (50 mg/kg) following identification of EEG confirmed neonatal seizure.
Also known as: Keppra
Intravenous load of phenobarbital (20 mg/kg)following EEG confirmation of seizure activity load.
Also known as: phenobarbitone
EEG
Efficacy of levetiracetam by assessment of the change from baseline in EEG on Day 15.
Time frame: At Day 28
Brain Parenchyma Alterations(MRI)
Efficacy of levetiracetam by assessment of the change of brain from baseline in MRI on Day 28.
Time frame: At Day 28
Neurodevelopment(Bayley Scores)
Efficacy of levetiracetam by assessment of the change from baseline to Day 28 in neurodevelopment via Bayley Scores of Infant Development Mental Development Index (BSID).
Time frame: At Day 28
Seizure Control Days
Efficacy of levetiracetam by assessment of seizure control days.
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Adverse Events（Abnormal Appearance）
This is a composition of general appearance, abdomen, skin, head and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Adverse Events（Abnormal Blood Pressure）
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Adverse Events(Pulse)
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Adverse Events(Respiratory)
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Abnormal Clinical Chemistry
Safety of levetiracetam by assessment of safety laboratory tests.
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Abnormal Hematology
Safety of levetiracetam by assessment of safety laboratory tests.
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Abnormal Clinical Urinalysis
Safety of levetiracetam by assessment of safety laboratory tests.
Time frame: From Day 1 to Day 28 post-dose in each period
Rate and extent of absorption by assessment of tmax
Comparison of tmax (time to reach maximum plasma concentration) of levetiracetam on Day 1 of each treatment period; up to 6 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose).
Time frame: At Day 1 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)
Rate and extent of absorption by assessment of Cmax
Comparison of Cmax (maximum observed plasma concentration) of levetiracetam on Day 1 of each treatment period; up to 6 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose).
Time frame: At Day 1 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)
Rate and extent of absorption by assessment of AUC(0-4)
Comparison of AUC(0-4) (Area under the plasma concentration-time curve from time zero to 4 hours after administration) of levetiracetam on Day 1 of each treatment period; up to 6 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose).
Time frame: At Day 1 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)
Rate and extent of absorption by assessment of Cmax,ss of levetiracetam
Comparison of Cmax,ss (observed maximum plasma concentration at steady state) of levetiracetam on Day 14 of each treatment period; up to 10 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose).
Time frame: At Day 14 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)
Rate and extent of absorption by assessment of AUC(0-24) of levetiracetam
Comparison of AUC(0-24) (Area under the plasma concentration-time curve from time zero to 24 hours after administration) of levetiracetam on Day 14 of each treatment period; up to 10 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose).
Time frame: At Day 14 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)
Rate and extent of absorption by assessment of tmax,ss of levetiracetam
Comparison of tmax,ss (time to reach maximum plasma concentration at steady state) of levetiracetam on Day 14 of each treatment period; up to 10 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose).
Time frame: At Day 14 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)
Rate and extent of absorption by assessment of Cavg,ss of levetiracetam
Comparison of Cavg,ss (average plasma concentration during a dosing interval at steady state) of levetiracetam on Day 14 of each treatment period; up to 10 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose).
Time frame: At Day 14 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)
Rate and extent of absorption by assessment of AUC(0-last) of levetiracetam
Comparison of AUC(0-last) (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration) of levetiracetam (i.e. in subjects with intensive pharmacokinetic assessments)
Time frame: At Day 1 and Day 14 in each period (in subjects with intensive pharmacokinetic assessments, on Day 1 at pre-dose and 15 and 30 minutes, and 1, 2 and 4 h post-dose, on Day 14 at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)
Rate and extent of absorption following multiple dose administration by assessment of Cmin of levetiracetam
Comparison of Cmin (predose concentration) of levetiracetam in each treatment period.
Time frame: At Day 1 and on Day 14 at pre-dose in each period
This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Fudan University