Neonatal SeizurePhase 4NCT07923734
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
A Phase 4 study testing Sezaby in people with Neonatal Seizure, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 27 days
- Conditions the study is for
- Neonatal Seizure
- What is being tested?
- Sezaby
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 27 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal Seizure
- Being tested
- Sezaby
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SezabyDrug
Also called Phenobarbital sodium
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 group | Role | What they receive |
|---|---|---|
| Sezaby | Experimental | 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. Receives: Drug: Sezaby |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through Day 5
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through Day 5
Plasma Concentration of Phenobarbital
Assessment of plasma concentrations of phenobarbital following administration of Sezaby.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923734
- Sponsor's protocol ID
- SEZA-24-01
- Status last verified
- Nov 2026
- First submitted
- 13 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Open-Label Study to Assess the Effect of Sezaby™ on Electrocardiographic Safety in Patients With Neonatal Seizures
- ClinicalTrials.gov ID
- NCT07923734
- Acronym / sponsor ID
- SEZA-24-01
- Conditions
- Neonatal Seizure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sezaby | Experimental | Drug: SezabyNeonates with seizures receiving intravenous Sezaby administered as loading dose(s) followed by maintenance dosing for up to 5 days according to the study protocol. |
Who may qualify
- Ages
- 0 to 27 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SezabyAlso: Phenobarbital sodiumSezaby (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. | Drug | Sezaby |
Primary outcome
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Time frame: Baseline through Day 5
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.
16 secondary outcomes
Change From Baseline in QT Interval Corrected Using Bazett's Formula (QTcB)
Time frame: Baseline through Day 5
Incidence of Treatment-Emergent Adverse Events
Time frame: 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
Time frame: Baseline through Day 5
Frequency of Treatment-Emergent Changes in Electrocardiogram Morphology
Time frame: Baseline through Day 5
Incidence of Categorical Outliers in QTcF, QTcB, Heart Rate, PR Interval, and QRS Interval
Time frame: Baseline through Day 5
Plasma Concentration of Phenobarbital
Time frame: Baseline through Day 5
A. Correlation Between Post-Conceptional Age and Change From Baseline in QTcF
Time frame: Baseline through Day 5
B. Correlation Between Post-Conceptional Age and Change From Baseline in QTcB
Time frame: Baseline through Day 5
A. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcF
Time frame: Baseline through Day 5
B. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcB
Time frame: Baseline through Day 5
C. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcF
Time frame: Baseline through Day 5
D. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcB
Time frame: Baseline through Day 5
E. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcF
Time frame: Baseline through Day 5
F. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcB
Time frame: Baseline through Day 5
A. Correlation Between Body Temperature and Change From Baseline in QTcF
Time frame: Baseline through Day 5
B. Correlation Between Body Temperature and Change From Baseline in QTcB
Time frame: Baseline through Day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sezaby in people with Neonatal Seizure, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Development (9122 66455645, clinical.trials@sparcmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) (time frame: Baseline through Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.