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Insufficient participant recruitment hindered the study's progress, preventing robust data collection and compromising statistical power
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This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse effects, including death, placebo-controlled studies are not appropriate for this population. This study is designed to show intravenous phenobarbital is effective at preventing subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenobarbital Sodium Injection 20mg | Active Comparator | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required). |
|
| Phenobarbital Sodium Injection 40mg | Active Comparator | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenobarbital Sodium Injection | Drug | The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | Percent of neonates who do not require additional seizure treatment after the first dose of phenobarbital during the first 24 hours after treatment. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | Percent of neonates who do not require additional seizure treatment after 2 hours of the first dose of phenobarbital. | 2 hours |
| Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Pergolizzi Jr., MD, MD | NEMA Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Cildren's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Children's National Hospital |
There is no plan to share IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenobarbital Sodium Injection 20mg | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required). Phenobarbital Sodium Injection: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. |
| FG001 | Phenobarbital Sodium Injection 40mg | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required). Phenobarbital Sodium Injection: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phenobarbital Sodium Injection 20mg | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required). Phenobarbital Sodium Injection: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | Percent of neonates who do not require additional seizure treatment after the first dose of phenobarbital during the first 24 hours after treatment. | Posted | Count of Participants | Participants | 24 hours |
|
All-Cause Mortality and Serious Adverse Events were assessed up to 30 days following the first treatment, on average 45 days. Other (Not Including Serious) Adverse Events were assessed for up to 24 hours following the first treatment and up to 4 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phenobarbital Sodium Injection 20mg | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required). Phenobarbital Sodium Injection: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | One subject (1 Group A) experienced one TEAE of moderate pulmonary hypertension. This TEAE was not expected, not related to the study drug, and resolved in 21 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Schutte | Hikma Pharmaceuticals | 440-201-5010 | aschutte@Hikma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2021 | Aug 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2023 | Aug 29, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020936 | Epilepsy, Benign Neonatal |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010634 | Phenobarbital |
| ID | Term |
|---|---|
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
Percent of neonates who do not require additional seizure treatment after the second dose of phenobarbital within the first 24 hours of treatment. |
| 24 hours |
| Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection. | Number of subject required monitoring of seizure burden over 48 hours following initial administration of the phenobarbital injection. | 48 hours |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| South Miami Hospital | Miami | Florida | 33143 | United States |
| Jamie Flores-Torres | Tampa | Florida | 33606 | United States |
| Matthew Butoryak | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Marshall Health | Huntington | West Virginia | 25701 | United States |
| Jordan University of Science and Technology (King Abdullah University Hospital, KAUH) | Irbid | 22110 | Jordan |
| BG001 | Phenobarbital Sodium Injection 40mg | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required). Phenobarbital Sodium Injection: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required). Phenobarbital Sodium Injection: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. |
|
|
| Secondary | Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | Percent of neonates who do not require additional seizure treatment after 2 hours of the first dose of phenobarbital. | Posted | Count of Participants | Participants | 2 hours |
|
|
|
| Secondary | Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital. | Percent of neonates who do not require additional seizure treatment after the second dose of phenobarbital within the first 24 hours of treatment. | Three subjects (two in the low-dose and one in the high-dose groups) received a first dose and no subsequent doses of the medication. One subject in the low-dose group received an initial dose (20 mg/kg) at 14:10 on July 15 and a second dose (20 mg/kg) at 17:25 on the same day. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection. | Number of subject required monitoring of seizure burden over 48 hours following initial administration of the phenobarbital injection. | One subject in the low-dose group received an initial dose (20 mg/kg) at 14:10 on July 15 and a second dose (20 mg/kg) at 17:25 on the same day. Maintenance doses of 5 mg/kg were administered to this subject once daily on July 16, 17, and 18. Only this subject required monitoring of seizure burden over 48 hours following initial administration of the phenobarbital injection | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 0 |
| 3 |
| EG001 | Phenobarbital Sodium Injection 40mg | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required). Phenobarbital Sodium Injection: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. | 0 | 1 | 0 | 1 | 0 | 1 |
|
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| D007232 |
| Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 |
| Heterocyclic Compounds |