Phase 2
Completed N=106
Efficacy of Intravenous Levetiracetam in Neonatal Seizures
Neonatal Seizures
Source: ClinicalTrials.gov NCT01720667 ↗
Enrolled (actual)
106
Serious AEs
5.7%
Results posted
Aug 2019
Primary outcomePrimary: Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) — 15; 24 Participants — p=<0.001
Summary
A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory.
Monitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) |
15; 24 | <0.001 sig |
| SECONDARY Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment |
8; 18 | <0.001 sig |
| SECONDARY Number of Neonates With Seizure Termination at 1 Hour After Treatment |
26; 28 | — |
| SECONDARY LEV Dose Escalation Component |
4; 3 | — |
| SECONDARY Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia |
6; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Newborns admitted to any of the study sites with electrographic seizures seizures.
- Term infants gestational age >36 weeks less than 2 weeks of age.
- Greater than 2200 grams.
- Infants for whom parental consent to participate in the study is obtained.
Exclusion Criteria
- Infants who are already receiving anticonvulsants
- If serum creatinine is greater than 1.6mM
- If seizures are due to correctable metabolic abnormalities (i.e. hypoglycaemia, hypocalcemia, hyponatremia)
- Subjects in whom death seems imminent, as assessed by the neonatologist.
Data sourced from ClinicalTrials.gov (NCT01720667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.