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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Clinical Development
- Numéro de téléphone: 9122 66455645
- E-mail: clinical.trials@sparcmail.com
Lieux d'étude
-
-
Michigan
-
Detroit, Michigan, États-Unis, 48201
- Site 1
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in QT Interval Corrected Using Bazett's Formula (QTcB)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SEZA-24-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .