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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Clinical Development
- Telefonní číslo: 9122 66455645
- E-mail: clinical.trials@sparcmail.com
Studijní místa
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Michigan
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Detroit, Michigan, Spojené státy, 48201
- Site 1
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Časové okno: Baseline through Day 5
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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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in QT Interval Corrected Using Bazett's Formula (QTcB)
Časové okno: Baseline through Day 5
|
Change from baseline in QT interval corrected for heart rate using Bazett's formula (QTcB) following treatment with Sezaby. |
Baseline through Day 5
|
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Incidence of Treatment-Emergent Adverse Events
Časové okno: First dose through Safety Follow-up (approximately 20 days)
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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)
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Change From Baseline in QTcF and QTcB Intervals in Participants With Hypoxic-Ischemic Encephalopathy (HIE) Compared With Participants Without HIE
Časové okno: Baseline through Day 5
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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
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Frequency of Treatment-Emergent Changes in Electrocardiogram Morphology
Časové okno: Baseline through Day 5
|
Frequency of treatment-emergent changes in electrocardiogram (ECG) morphology following treatment with Sezaby. |
Baseline through Day 5
|
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Incidence of Categorical Outliers in QTcF, QTcB, Heart Rate, PR Interval, and QRS Interval
Časové okno: 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. |
Baseline through Day 5
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Plasma Concentration of Phenobarbital
Časové okno: Baseline through Day 5
|
Assessment of plasma concentrations of phenobarbital following administration of Sezaby. |
Baseline through Day 5
|
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A. Correlation Between Post-Conceptional Age and Change From Baseline in QTcF
Časové okno: 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. |
Baseline through Day 5
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B. Correlation Between Post-Conceptional Age and Change From Baseline in QTcB
Časové okno: Baseline through Day 5
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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
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A. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcF
Časové okno: Baseline through Day 5
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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
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B. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcB
Časové okno: 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. |
Baseline through Day 5
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C. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcF
Časové okno: Baseline through Day 5
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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
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D. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcB
Časové okno: 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. |
Baseline through Day 5
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E. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcF
Časové okno: Baseline through Day 5
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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
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F. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcB
Časové okno: Baseline through Day 5
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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
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A. Correlation Between Body Temperature and Change From Baseline in QTcF
Časové okno: Baseline through Day 5
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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
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B. Correlation Between Body Temperature and Change From Baseline in QTcB
Časové okno: 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. |
Baseline through Day 5
|
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Další relevantní podmínky MeSH
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