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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Clinical Development
- Número de telefone: 9122 66455645
- E-mail: clinical.trials@sparcmail.com
Locais de estudo
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Site 1
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Prazo: 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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in QT Interval Corrected Using Bazett's Formula (QTcB)
Prazo: Baseline through Day 5
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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
Prazo: 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
Prazo: 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
Prazo: Baseline through Day 5
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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
Prazo: Baseline through Day 5
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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
Prazo: Baseline through Day 5
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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
Prazo: 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 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
Prazo: 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
Prazo: 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
Prazo: 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 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
Prazo: 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
Prazo: 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 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline through Day 5
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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
Datas de registro do estudo
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Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SEZA-24-01
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