What this study is
Simplified from ClinicalTrials.govTesting a medicine given through a vein (Sezaby, phenobarbital sodium) to learn about its safety for the heart, including a heart rhythm measure called the QT interval, in newborns with seizures, ages 0 to 27 days.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- Sezaby
Intervention · DRUG
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.
Study details
- Official title
- A Prospective, Single-Arm, Open-Label Study to Assess the Effect of Sezaby™ on Electrocardiographic Safety in Patients With Neonatal Seizures
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Conditions
- Neonatal Seizure
- Enrolling
- 45 people
- Starts
- 2026-12
- Est. completion
- 2028-03
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Days – 27 DaysSex ALLHealthy volunteers Not acceptedYou may qualify if
- Neonates with seizures confirmed by continuous electroencephalogram (cEEG) monitoring.
- Acute symptomatic seizure etiologies other than correctable metabolic abnormalities.
- Term or preterm infants with postnatal age less than 28 days.
- Body weight of at least 1 kg.
- Written informed consent from a parent or legal guardian.
You can't join if
- Prior treatment with anticonvulsant medications.
- Correctable metabolic abnormalities associated with seizure cessation when corrected.
- Baseline QT interval corrected using Fridericia's formula (QTcF) greater than 450 milliseconds.
- Significant risk factors for torsade de pointes, including congenital long QT syndrome or significant cardiac disease.
- Renal failure.
- Acute porphyria.
- Neonates in whom death is considered imminent in the opinion of the investigator.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSite 1
Detroit, Michigan, United States
Study team
Sponsor
Sun Pharma Advanced Research Company Limited
Study ID SEZA-24-01
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.