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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Clinical Development
- Número de teléfono: 9122 66455645
- Correo electrónico: clinical.trials@sparcmail.com
Ubicaciones de estudio
-
-
Michigan
-
Detroit, Michigan, Estados Unidos, 48201
- Site 1
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Periodo de tiempo: 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. |
Baseline through Day 5
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in QT Interval Corrected Using Bazett's Formula (QTcB)
Periodo de tiempo: 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
|
|
Incidence of Treatment-Emergent Adverse Events
Periodo de tiempo: 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. |
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
Periodo de tiempo: 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. |
Baseline through Day 5
|
|
Frequency of Treatment-Emergent Changes in Electrocardiogram Morphology
Periodo de tiempo: Baseline through Day 5
|
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
Periodo de tiempo: 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
|
|
Plasma Concentration of Phenobarbital
Periodo de tiempo: Baseline through Day 5
|
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
Periodo de tiempo: 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
|
|
B. Correlation Between Post-Conceptional Age and Change From Baseline in QTcB
Periodo de tiempo: 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. |
Baseline through Day 5
|
|
A. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcF
Periodo de tiempo: 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. |
Baseline through Day 5
|
|
B. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcB
Periodo de tiempo: 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
|
|
C. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcF
Periodo de tiempo: 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. |
Baseline through Day 5
|
|
D. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcB
Periodo de tiempo: 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
|
|
E. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcF
Periodo de tiempo: 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. |
Baseline through Day 5
|
|
F. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcB
Periodo de tiempo: 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. |
Baseline through Day 5
|
|
A. Correlation Between Body Temperature and Change From Baseline in QTcF
Periodo de tiempo: 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. |
Baseline through Day 5
|
|
B. Correlation Between Body Temperature and Change From Baseline in QTcB
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SEZA-24-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .