Neonatal SeizuresPhase 4NCT03107507
Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG
A Phase 4 study testing Levetiracetam and Phenobarbital in people with Neonatal Seizures, run by Cairo University at 1 site in Egypt.
Trial summary
Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide. Read more about this study
- Who is it for?
- Ages 1 hour to 30 days
- Conditions the study is for
- Neonatal Seizures
- What is being tested?
- Levetiracetam and Phenobarbital
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2017to 30 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 1 hour to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All full term neonates experiencing seizures due to; post-hypoxic or post-ischemic encephalopathy, intracerebral hemorrhage, cerebral infection, inborn errors of metabolism or malformations of cortical development
Who cannot join
- Preterm neonates
- Full term neonates with seizures due to metabolic derangements (hypoglycemia, hypocalcemia or hypomagnesemia)
- Full term neonates with impaired renal functions.
Trial locations and contacts
1 site in 1 country.
Aliaa A Ali, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Children's Hospital (Abulreesh)
Cairo Governorate
Yara Shaheen
About this study
Official title: Efficacy of Levetiracetam in Control of Neonatal Seizures
Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as, levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal population, offering the potential for seizure treatment with a significantly better side-effect profile.
Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has been in clinical use for almost a decade in adults and older children with good efficacy, an excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved and used for treatment of seizures in infants starting one month of age since 2012.
The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a first-line drug in control of neonatal seizures. The investigators monitor the efficacy through assessment of frequency of seizures before and after drug administration, amplitude integrated EEG changes in background activity and seizure frequency in participants, duration taken for participants to be seizure free and short term neurodevelopmental outcome and EEG at 3 months of age
- Conditions
- Neonatal Seizures
- Being tested
- Levetiracetam, Phenobarbital
- Keywords
- EEG with Periodic Abnormalities, Levetiracetam, Phenobarbitone, neonatal seizures, Neurodevelopmental Abnormality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Given in a bolus dose first 50mg/kg as levetiracetam reaches a therapeutic serum level rapidly in 1.3 hours. Titration will not be attempted in our study to reach drug level rapidly and consequent rapid effective control of seizures. Maintenance dose is then given at a dose of 10 - 40mg/kg/day divided every 12 hours.
PhenobarbitalDrug
Phenobarbital is given intravenously in the form of a loading dose of 15mg/kg that can be repeated after a 20 minute interval not to exceed 30mg/kg then a maintenance dose 2-4 mg/kg/day divided every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Active comparator | Levetiracetam given in oral form via oro-gastric tube, first a bolus dose 40-50mg/kg then maintenance dose 10-30 mg/kg/day divided every 12 hours.
Duration: until seizure free Receives: Drug: Levetiracetam |
| Phenobarbital | Active comparator | Phenobarbital given in IV form, loading dose 20mg/kg that can be repeated after a 20 minute interval not to exceed 40mg/kg then maintenance dose 2-4 mg/kg/day divided every 12 hours.
Duration: until seizure free Receives: Drug: Phenobarbital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden.
Number of seizures before and after levetiracetam administration in comparison to phenobarbital.
Measured: 72 hours
Efficacy of levetiracetam in rapid control of neonatal seizures compared to phenobarbital.
Number of hours taken to achieve seizure freedom after administration of levetiracetam versus phenobarbital.
Measured: 72 hours
Secondary outcomes (6)
Dose escalation data about levetiracetam through studying the efficacy of further dose administration in non responders.
Number of originally non responder participants who achieved seizure control with higher doses of levetiracetam.
Measured: 72 hours
Adequacy of levetiracetam as a single agent antiepileptic drug in control of neonatal seizures.
Number of participants who require addition of second line antiepileptic drug to control seizures after levetiracetam versus phenobarbital use.
Measured: 30 days
Accuracy of amplitude integrated EEG monitoring in detecting neonatal seizures before and after antiepileptic drug use.
Number of seizures detected by aEEG before and after antiepileptic drug use.
Measured: 48 hours
Effect of levetiracetam on aEEG background activity of participants.
Number of participants with normalization of background activity after administration of levetiracetam versus phenobarbital.
Measured: 48 hours
The short term clinical outcome of patients with neonatal seizures after treatment with levetiracetam.
Neurodevelopmental assessment through detecting presence of following milestones:
- Head control
- Social smile
- Visual fixation and pursuit
- Turning towards sounds
Measured: 3 months
The short term electroencephalographic outcome of patients with neonatal seizures after treatment with levetiracetam
Number of participants with presence of epileptogenic activity on follow up electroencephalogram.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start25 Mar 2017
- Primary completion30 Oct 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SeizuresStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Salah Shaheen, Cairo University
- Investigators
- Omneya G Afify, MD, Study chair, Cairo UniversityIman F Iskander, MD, Study director, Cairo UniversityAliaa A Ali, MD, Principal investigator, Cairo UniversityYara S Shaheen, MSc., Principal investigator, Cairo UniversityWalaa Shaarany, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107507
- Sponsor's protocol ID
- YSShaheen
- Status last verified
- Mar 2017
- First submitted
- 22 Feb 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Levetiracetam in Control of Neonatal Seizures
- ClinicalTrials.gov ID
- NCT03107507
- Acronym / sponsor ID
- YSShaheen
- Conditions
- Neonatal Seizures
- Keywords
- EEG with Periodic Abnormalities, Levetiracetam, Phenobarbitone, neonatal seizures, Neurodevelopmental Abnormality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Mar 2017 (actual)
- Primary completion
- 30 Oct 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as, levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal population, offering the potential for seizure treatment with a significantly better side-effect profile.
Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has been in clinical use for almost a decade in adults and older children with good efficacy, an excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved and used for treatment of seizures in infants starting one month of age since 2012.
The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a first-line drug in control of neonatal seizures. The investigators monitor the efficacy through assessment of frequency of seizures before and after drug administration, amplitude integrated EEG changes in background activity and seizure frequency in participants, duration taken for participants to be seizure free and short term neurodevelopmental outcome and EEG at 3 months of age
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Active comparator | Drug: LevetiracetamLevetiracetam given in oral form via oro-gastric tube, first a bolus dose 40-50mg/kg then maintenance dose 10-30 mg/kg/day divided every 12 hours. Duration: until seizure free |
| Phenobarbital | Active comparator | Drug: PhenobarbitalPhenobarbital given in IV form, loading dose 20mg/kg that can be repeated after a 20 minute interval not to exceed 40mg/kg then maintenance dose 2-4 mg/kg/day divided every 12 hours. Duration: until seizure free |
Who may qualify
- Ages
- 1 hour to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All full term neonates experiencing seizures due to; post-hypoxic or post-ischemic encephalopathy, intracerebral hemorrhage, cerebral infection, inborn errors of metabolism or malformations of cortical development
Key exclusion criteria (3 listed)
- Preterm neonates
- Full term neonates with seizures due to metabolic derangements (hypoglycemia, hypocalcemia or hypomagnesemia)
- Full term neonates with impaired renal functions.
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 |
|---|---|---|
| LevetiracetamGiven in a bolus dose first 50mg/kg as levetiracetam reaches a therapeutic serum level rapidly in 1.3 hours. Titration will not be attempted in our study to reach drug level rapidly and consequent rapid effective control of seizures. Maintenance dose is then given at a dose of 10 - 40mg/kg/day divided every 12 hours. | Drug | Levetiracetam |
| PhenobarbitalPhenobarbital is given intravenously in the form of a loading dose of 15mg/kg that can be repeated after a 20 minute interval not to exceed 30mg/kg then a maintenance dose 2-4 mg/kg/day divided every 12 hours. | Drug | Phenobarbital |
Primary outcome
Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden.
Time frame: 72 hours
Number of seizures before and after levetiracetam administration in comparison to phenobarbital.
Efficacy of levetiracetam in rapid control of neonatal seizures compared to phenobarbital.
Time frame: 72 hours
Number of hours taken to achieve seizure freedom after administration of levetiracetam versus phenobarbital.
6 secondary outcomes
Dose escalation data about levetiracetam through studying the efficacy of further dose administration in non responders.
Time frame: 72 hours
Adequacy of levetiracetam as a single agent antiepileptic drug in control of neonatal seizures.
Time frame: 30 days
Accuracy of amplitude integrated EEG monitoring in detecting neonatal seizures before and after antiepileptic drug use.
Time frame: 48 hours
Effect of levetiracetam on aEEG background activity of participants.
Time frame: 48 hours
The short term clinical outcome of patients with neonatal seizures after treatment with levetiracetam.
Time frame: 3 months
The short term electroencephalographic outcome of patients with neonatal seizures after treatment with levetiracetam
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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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.
Aliaa A Ali, MD contact
Omneya G Afify, MD study chair
Cairo University
Iman F Iskander, MD study director
Cairo University
Aliaa A Ali, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levetiracetam and Phenobarbital in people with Neonatal Seizures, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yara S Shaheen, Msc (01227981313 ext. 002, yarasalah.shaheen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden. (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 11 Apr 2017.