Sun Pharma Advanced Research Company Limited
This Phase 4, multicenter, single-arm, open-label study evaluates the effect of intravenous Sezaby (phenobarbital sodium) on electrocardiographic safety, including the QT interval, in neonates with seizures.
This Phase 4, multicenter, single-arm, open-label study evaluates the effect of Sezaby on electrocardiographic safety, including the QT interval, in neonates with seizures. Participants will receive intravenous Sezaby and undergo electrocardiographic and safety assessments during treatment.
Inclusion Criteria: 1. Neonates with seizures confirmed by continuous electroencephalogram (cEEG) monitoring. 2. Acute symptomatic seizure etiologies other than correctable metabolic abnormalities. 3. Term or preterm infants with postnatal age less than 28 days. 4. Body weight of at least 1 kg. 5. Written informed consent from a parent or legal guardian. Exclusion Criteria: 1. Prior treatment with anticonvulsant medications. 2. Correctable metabolic abnormalities associated with seizure cessation when corrected. 3. Baseline QT interval corrected using Fridericia's formula (QTcF) greater tha…
Sezaby (phenobarbital sodium for injection) is administered as intravenous loading and maintenance doses over a treatment period of up to 5 days for the treatment of neonatal seizures.
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