A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Recruiting
Phase 2
Interventional Study
Neonatal Seizure
Neonatal Encephalopathy
Hypoxic-Ischemic Encephalopathy
Seizure Newborn
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 1 Month
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 133 (estimated)
- Sponsor
- University of California, San Diego · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Inf…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* 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…
Contacts