Epilepsy, Benign NeonatalPhase 3NCT04320940
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
A Phase 3 study testing Phenobarbital Sodium Injection in people with Epilepsy, Benign Neonatal, run by NEMA Research, Inc. at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 34 to 44 weeks
- Conditions the study is for
- Epilepsy, Benign Neonatal
- What is being tested?
- Phenobarbital Sodium Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 12 Mar 2021to 1 Feb 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Marshall Health
Huntington, West Virginia, 25701
Arkansas Cildren's Hospital
Little Rock, Arkansas, 72202
South Miami Hospital
Miami, Florida, 33143
Matthew Butoryak
Pittsburgh, Pennsylvania, 15213
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Jamie Flores-Torres
Tampa, Florida, 33606
Children's National Hospital
Washington D.C., District of Columbia, 20010
Jordan1 site
Jordan University of Science and Technology (King Abdullah University Hospital, KAUH)
Irbid, 22110
About this study
Official title: A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
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.
- Conditions
- Epilepsy, Benign Neonatal
- Being tested
- Phenobarbital Sodium Injection
- Keywords
- Neonatal Seizures, Phenobarbital, Anticonvulsants
- Medical subject headings
- Epilepsy, Benign Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenobarbital Sodium InjectionDrug
Also called Phenobarbital
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Phenobarbital Sodium Injection |
| 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). Receives: Drug: Phenobarbital Sodium Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
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.
Measured: 2 hours
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.
Measured: 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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start12 Mar 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: Insufficient participant recruitment hindered the study's progress, preventing robust data collection and compromising statistical power
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epilepsy, Benign NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEMA Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Pergolizzi Jr., MD, MD, Principal investigator, NEMA Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320940
- Sponsor's protocol ID
- MI-5780
- Status last verified
- Oct 2023
- First submitted
- 23 Mar 2020
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
- ClinicalTrials.gov ID
- NCT04320940
- Acronym / sponsor ID
- MI-5780
- Conditions
- Epilepsy, Benign Neonatal
- Keywords
- Neonatal Seizures, Phenobarbital, Anticonvulsants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient participant recruitment hindered the study's progress, preventing robust data collection and compromising statistical power
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NEMA Research, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Posted 26 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenobarbital Sodium Injection 20mg | Active comparator | Drug: Phenobarbital Sodium InjectionFollowing 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 | Drug: Phenobarbital Sodium InjectionFollowing confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required). |
Who may qualify
- Ages
- 34 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenobarbital Sodium InjectionAlso: PhenobarbitalThe 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. | Drug | Phenobarbital Sodium Injection 20mg, Phenobarbital Sodium Injection 40mg |
Primary outcome
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
Time frame: 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.
3 secondary outcomes
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
Time frame: 2 hours
Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital.
Time frame: 24 hours
Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection.
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Pergolizzi Jr., MD, MD principal investigator
NEMA Research, Inc.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenobarbital Sodium Injection in people with Epilepsy, Benign Neonatal, run by NEMA Research, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.