Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
NCT07923734, Phase 4, Not yet recruiting, Sun Pharma Advanced Research Company Limited
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures | ClinicalTrials.gov |
| NCT number | NCT07923734 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 45 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sun Pharma Advanced Research Company Limited | ClinicalTrials.gov |
| Conditions | Neonatal Seizure | ClinicalTrials.gov |
| Interventions | Sezaby | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in QT Interval Corrected Using Bazett's Formula (QTcB) | Baseline through Day 5 | Change from baseline in QT interval corrected for heart rate using Bazett's formula (QTcB) following treatment with Sezaby. | ClinicalTrials.gov |
| Secondary | Incidence of Treatment-Emergent Adverse Events | First dose through Safety Follow-up (approximately 20 days) | Assessment of safety based on the incidence of treatment-emergent adverse events (TEAEs) following administration of Sezaby. | ClinicalTrials.gov |
| Secondary | Change From Baseline in QTcF and QTcB Intervals in Participants With Hypoxic-Ischemic Encephalopathy (HIE) Compared With Participants Without HIE | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | Frequency of Treatment-Emergent Changes in Electrocardiogram Morphology | Baseline through Day 5 | Frequency of treatment-emergent changes in electrocardiogram (ECG) morphology following treatment with Sezaby. | ClinicalTrials.gov |
| Secondary | Incidence of Categorical Outliers in QTcF, QTcB, Heart Rate, PR Interval, and QRS Interval | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | Plasma Concentration of Phenobarbital | Baseline through Day 5 | Assessment of plasma concentrations of phenobarbital following administration of Sezaby. | ClinicalTrials.gov |
| Secondary | A. Correlation Between Post-Conceptional Age and Change From Baseline in QTcF | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | B. Correlation Between Post-Conceptional Age and Change From Baseline in QTcB | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | A. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcF | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | B. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcB | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | C. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcF | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | D. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcB | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | E. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcF | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | F. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcB | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | A. Correlation Between Body Temperature and Change From Baseline in QTcF | Baseline through Day 5 | 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. | ClinicalTrials.gov |
| Secondary | B. Correlation Between Body Temperature and Change From Baseline in QTcB | Baseline through Day 5 | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)