A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
NCT ID: NCT05610085
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
133 participants
INTERVENTIONAL
2023-03-24
2027-12-31
Brief Summary
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If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site.
Funding Source- FDA OOPD
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Detailed Description
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Primary Aim: To determine the recommended maximal safe dose of LEV in the setting of neonatal seizures of mild to moderate severity.
If 60mg/kg LEV does not control seizures, subjects will be randomised to receive either additional LEV or PHB. LEV dose will be escalated in 30mg/kg increments to a maximal dose of 150mg/kg total loading dose. We will use a continual reassessment method to determine the maximal safe and tolerated dose.
Secondary/exploratory aims:
* To study the pharmacokinetics of high dose LEV in neonates with seizures of mild to moderate severity.
* To estimate the additional efficacy of higher doses of LEV in neonates with seizures of mild to moderate severity.
* To improve technologies for the prompt detection of neonatal seizures: We will assess the latest version of Persyst's neonatal seizure detector.
Research Design
This is a Phase IIb, open label dose-escalation, preliminary safety and efficacy study. An active drug treatment control arm (PHB group) is included in the study design. This study is not designed or powered to compare high dose LEV and PHB groups, however, the randomized control group will help with interpretation of adverse events and seizure cessation efficacy seen in the high dose escalation group. This is particularly important because of the high rates of morbidity in neonates with seizures.
24-hour seizure control endpoint: cEEG reviewed by a neurophysiologist will be used for assessing 24-hour seizure control. Treatment will be considered effective in achieving 24-hour seizure control if there is a seizure burden less than 30 seconds in the 24 hours following the dose. Change in seizure burden in 2-hour post treatment period will also be assessed.
Intervention If seizure activity occurs participants will be enrolled and will receive 60mg/kg LEV.
If seizures continue babies will then be randomised to receive either:
* Additional LEV at a higher dose (30 mg/kg, 60 mg/kg, or 90 mg/kg depending on the stage of the study), OR
* PHB at 20-40 mg/kg. Maintenance treatment will continue for 5 days, either IV or orally if baby is tolerating feeds.
LEV discontinuation or addition of PHB: there are multiple criteria for transition to, or addition of, PHB treatment if required for seizure control.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose escalation with LEV
Additional LEV at a higher dose (30 mg/kg, 60 mg/kg, or 90 mg/kg depending on the stage of the study).
Levetiracetam Injection
Neonates will be treated with intravenous levetiracetam 60mg/kg for first line management of seizures, and if seizures persist will be randomized to receive higher dose Levetiracetam or standard of care phenobarbital
Standard of care Phenobarbital
Treatment with Phenobarbital 20mg/kg IV and if needed a further 20mg/kg totalling 40mg/kg
Phenobarbital Sodium Injection
Standard of care for neonatal seizures
Interventions
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Levetiracetam Injection
Neonates will be treated with intravenous levetiracetam 60mg/kg for first line management of seizures, and if seizures persist will be randomized to receive higher dose Levetiracetam or standard of care phenobarbital
Phenobarbital Sodium Injection
Standard of care for neonatal seizures
Eligibility Criteria
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Inclusion Criteria
* all seizure aetiologies except correctable metabolic abnormalities such as hypoglycaemia and hypocalcaemia;
* Term neonates (corrected gestational age between 35 and 44 weeks, postnatal age less than 28 days);
* weight \> 2200g.
* Parental ability to comprehend and provide written informed consent
Exclusion Criteria
* Renal failure defined as anuria in the first 24 hours of life;
* Subjects in whom death seems imminent;
* Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.
1 Month
ALL
No
Sponsors
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University of Minnesota
OTHER
Rady Children's Hospital, San Diego
OTHER
Auckland City Hospital
OTHER_GOV
University of Auckland, New Zealand
OTHER
Middlemore Hospital, New Zealand
OTHER
University of California, San Diego
OTHER
Responsible Party
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Richard H. Haas
Professor
Principal Investigators
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Sonya G Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Cynthia M Sharpe, M.D.
Role: PRINCIPAL_INVESTIGATOR
Auckland City Hospital
Jeff J Gold, M.D. PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Richard H Haas, MBBChir
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
San Diego, California, United States
University of Minnesota
Minneapolis, Minnesota, United States
Auckland City Hospital
Auckland, Auckland, New Zealand
Middlemore Hospital
Auckland, Auckland, New Zealand
Capital and Coast District Health Board, Te Whatu Ora, Health New Zealand
Wellington, Wellington Region, New Zealand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FD-R-6335
Identifier Type: -
Identifier Source: org_study_id
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