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New treatment option for Neonatal Seizure
Official title A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
ClinicalTrials.gov ID: NCT05610085
What this study is testing
What is Levetiracetam Injection?
Levetiracetam Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neonatal seizure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg/kg.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 1
You may be able to join if
- at risk for seizures or suspected to be having seizures;
- 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
You likely can't join if
- Cumulative seizure burden of 8 minutes/ hour or more in phases 1 and 2, Cumulative seizure burden of 20 minutes/hour or more in phase 3;
- Renal failure defined as anuria in the first 24 hours of life;
- people in whom death seems imminent;
- Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Minneapolis, Minnesota, United States
- Auckland, Auckland, New Zealand
- Wellington, Wellington Region, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 1 month. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Minneapolis, Minnesota, United States; Auckland, Auckland, New Zealand; Wellington, Wellington Region, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.