Levetiracetam Treatment of Neonatal Seizures

Fudan University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Neonatal Seizures

Treatments: Drug: Oral levetiracetam; Drug: Intravenous phenobarbital

Study type: Interventional

Funder types: Other

Identifiers

NCT02550028

CHFudanU_NNICU3

Details and patient eligibility

About

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.

Full description

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:

1. To determine the efficacy of oral Levetiracetam in terminating neonatal seizures by EEG in the Neonatal Neurological Intensive Care Unit (NNICU).
2. To determine dose escalation data by studying the additional efficacy of a further dose in non responders.
3. To determine additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study.
4. To determine further safety data of oral Levetiracetam in neonates.

Enrollment: 60 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

Neonatal seizure occurred and was proved by EEG according to abnormal discharge of brain. one or more of the following :

1. Male or female term baby with gestational >37 weeks and postnatal age < or= 28 days
2. Birthweight >2500g
3. Written informed consent of parent or guardian

Exclusion criteria

1. Babies who have been close to death
2. Seizure occurred by metabolic factors (hypoglycemia, hypocalcemia, electrolyte disorder)
3. Babies who have received phenobarbitone or any other anticonvulsive medication before hospitalization
4. Abnormal renal function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Oral levetiracetam

Experimental group

Description:

Oral levetiracetam 50 mg/kg loading dose. 10 mg/kg 8 hourly maintenance

Treatment:

Drug: Oral levetiracetam

Intravenous phenobarbital

Active Comparator group

Description:

Intravenous phenobarbital 20 loading dose (add to 40 mg/kg if seizure discontrol). 5 mg/kg 24 hourly maintenance

Treatment:

Drug: Intravenous phenobarbital