Trial Outcomes & Findings for Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures (NCT NCT04320940)

NCT ID: NCT04320940

Last Updated: 2023-10-26

Results Overview

Percent of neonates who do not require additional seizure treatment after the first dose of phenobarbital during the first 24 hours after treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 4 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2023-10-26

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	3	1
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

Baseline characteristics by cohort

Measure	Phenobarbital Sodium Injection 20mg n=3 Participants 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.	Phenobarbital Sodium Injection 40mg n=1 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.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Percent of neonates who do not require additional seizure treatment after the first dose of phenobarbital during the first 24 hours after treatment.

Outcome measures

Measure	Phenobarbital Sodium Injection 20mg n=3 Participants 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.	Phenobarbital Sodium Injection 40mg n=1 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.
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 hours

Percent of neonates who do not require additional seizure treatment after 2 hours of the first dose of phenobarbital.

Outcome measures

Measure	Phenobarbital Sodium Injection 20mg n=3 Participants 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.	Phenobarbital Sodium Injection 40mg n=1 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.
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 hours

Population: 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.

Percent of neonates who do not require additional seizure treatment after the second dose of phenobarbital within the first 24 hours of treatment.

Outcome measures

Measure	Phenobarbital Sodium Injection 20mg n=1 Participants 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.	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.
Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital.	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours

Population: 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

Number of subject required monitoring of seizure burden over 48 hours following initial administration of the phenobarbital injection.

Outcome measures

Measure	Phenobarbital Sodium Injection 20mg n=3 Participants 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.	Phenobarbital Sodium Injection 40mg n=1 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.
Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection.	1 Participants	0 Participants

Adverse Events

Phenobarbital Sodium Injection 20mg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Phenobarbital Sodium Injection 40mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phenobarbital Sodium Injection 20mg n=3 participants at risk 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.	Phenobarbital Sodium Injection 40mg n=1 participants at risk 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.
Respiratory, thoracic and mediastinal disorders pulmonary hypertension	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Amy Schutte

Hikma Pharmaceuticals

Phone: 440-201-5010

Email: aschutte@Hikma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place