Epilepsy, Benign Neonatal Clinical Trial
Official title:
A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
| Verified date | October 2023 |
| Source | NEMA Research, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 4 |
| Est. completion date | February 1, 2023 |
| Est. primary completion date | February 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 34 Weeks to 44 Weeks |
| Eligibility | Inclusion Criteria: - Male or female neonates with a gestational age of = 34 - =44 weeks admitted into the NICU with a high probability of developing seizures (e.g., HIE, stroke, intracerebral hemorrhage, central nervous system infection) - Parental informed consent (in-person or remote consent) - Undergoing continuous video electroencephalogram (cvEEG) monitoring - Has evidence of electrographic seizure burden of at least 30 seconds/h Exclusion Criteria: - Received anticonvulsant treatment, including phenobarbital, prior to randomization (with exception of lorazepam administered for sedation > 24 hours before enrollment) - Strong suspicion or confirmed diagnosis of brain malformation, inborn error of metabolism genetic syndrome, or major congenial malformation prior to randomization - Seizures responding to correction of hypoglycemia, hypocalcemia or any other metabolic disorder - Death appears to be imminent as assessed by the NICU attending physician - Is currently enrolled in another study assessing the same and/or similar primary/secondary endpoints with/without drug treatment. |
| Country | Name | City | State |
|---|---|---|---|
| Jordan | Jordan University of Science and Technology (King Abdullah University Hospital, KAUH) | Irbid' | |
| United States | Marshall Health | Huntington | West Virginia |
| United States | Arkansas Cildren's Hospital | Little Rock | Arkansas |
| United States | South Miami Hospital | Miami | Florida |
| United States | Matthew Butoryak | Pittsburgh | Pennsylvania |
| United States | UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Jamie Flores-Torres | Tampa | Florida |
| United States | Children's National Hospital | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| NEMA Research, Inc. |
United States, Jordan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 24 hours | |
| 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. | 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. | 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. | 48 hours |