Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures

A Prospective, Single-Arm, Open-Label Study to Assess the Effect of Sezaby™ on Electrocardiographic Safety in Patients With Neonatal Seizures

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neonatal Seizure
• Intervention / Treatment: Drug: Sezaby

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Clinical Development; Phone Number: 9122 66455645; Email: clinical.trials@sparcmail.com

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 than 450 milliseconds.
4. Significant risk factors for torsade de pointes, including congenital long QT syndrome or significant cardiac disease.
5. Renal failure.
6. Acute porphyria.
7. Neonates in whom death is considered imminent in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sezaby; Neonates with seizures receiving intravenous Sezaby administered as loading dose(s) followed by maintenance dosing for up to 5 days according to the study protocol.	Drug: Sezaby; 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.; Other Names: Phenobarbital sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)	Change from baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) following treatment with Sezaby. QTcF values will be assessed from electrocardiogram recordings obtained during the treatment period.	Baseline through Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in QT Interval Corrected Using Bazett's Formula (QTcB)	Change from baseline in QT interval corrected for heart rate using Bazett's formula (QTcB) following treatment with Sezaby.	Baseline through Day 5
Incidence of Treatment-Emergent Adverse Events	Assessment of safety based on the incidence of treatment-emergent adverse events (TEAEs) following administration of Sezaby.	First dose through Safety Follow-up (approximately 20 days)
Change From Baseline in QTcF and QTcB Intervals in Participants With Hypoxic-Ischemic Encephalopathy (HIE) Compared With Participants Without HIE	Change from baseline in QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) in participants with HIE compared with participants without HIE following treatment with Sezaby.	Baseline through Day 5
Frequency of Treatment-Emergent Changes in Electrocardiogram Morphology	Frequency of treatment-emergent changes in electrocardiogram (ECG) morphology following treatment with Sezaby.	Baseline through Day 5
Incidence of Categorical Outliers in QTcF, QTcB, Heart Rate, PR Interval, and QRS Interval	Incidence of categorical outliers in QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), heart rate (HR), PR interval, and QRS interval following treatment with Sezaby.	Baseline through Day 5
Plasma Concentration of Phenobarbital	Assessment of plasma concentrations of phenobarbital following administration of Sezaby.	Baseline through Day 5
A. Correlation Between Post-Conceptional Age and Change From Baseline in QTcF	Correlation between post-conceptional age, measured in completed weeks, and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately at each protocol-specified ECG assessment time point.	Baseline through Day 5
B. Correlation Between Post-Conceptional Age and Change From Baseline in QTcB	Correlation between post-conceptional age, measured in completed weeks, and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately at each protocol-specified ECG assessment time point.	Baseline through Day 5
A. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcF	Correlation between daily serum sodium concentration, measured by the clinical laboratory (mmol/L), and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately for each protocol-specified ECG assessment time point.	Baseline through Day 5
B. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcB	Correlation between daily serum sodium concentration, measured by the clinical laboratory (mmol/L), and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately for each protocol-specified ECG assessment time point.	Baseline through Day 5
C. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcF	Correlation between daily serum potassium concentration, measured by the clinical laboratory (mmol/L), and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately for each protocol-specified ECG assessment time point.	Baseline through Day 5
D. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcB	Correlation between daily serum potassium concentration, measured by the clinical laboratory (mmol/L), and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings.	Baseline through Day 5
E. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcF	Correlation between daily serum calcium concentration, measured by the clinical laboratory (mg/dL or mmol/L per protocol laboratory reporting), and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings.	Baseline through Day 5
F. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcB	Correlation between daily serum calcium concentration, measured by the clinical laboratory (mg/dL or mmol/L per protocol laboratory reporting), and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings.	Baseline through Day 5
A. Correlation Between Body Temperature and Change From Baseline in QTcF	Correlation between body temperature, measured in degrees Celsius at or near each protocol-specified ECG assessment, and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately at each protocol-specified ECG assessment time point.	Baseline through Day 5
B. Correlation Between Body Temperature and Change From Baseline in QTcB	A correlation coCorrelation between body temperature, measured in degrees Celsius at or near each protocol-specified ECG assessment, and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately at each protocol-specified ECG assessment time point.efficient will be calculated across participants separately at each protocol-specified ECG assessment time point.	Baseline through Day 5

Collaborators and Investigators

• Sponsor: Sun Pharma Advanced Research Company Limited

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: October 13, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pyrimidinones; Barbiturates; Phenobarbital
• Other Study ID Numbers: SEZA-24-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No