Levetiracetam vs phenobarbital for prolonged seizures in children unresponsive to benzodiazepines
Official title: Intravenous Levetiracetam Versus Intravenous Phenobarbital in Children With Prolonged Seizures Unresponsive to Benzodiazepines
Run by Ministry of Health and Sports, Myanmar · NCT07098728 · Data updated 2026-11-12
This trial will test whether intravenous levetiracetam or phenobarbital stops prolonged seizures faster in children who do not respond to two doses of benzodiazepines.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Month to 12 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Ministry of Health and Sports, Myanmar Government |
| Locations | 2 sites (Yangon, Yangon and 1 other locations) |
| Status | Recruiting |
| Started | July 22, 2025 |
| Main results expected | March 28, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | August 1, 2025 |
| Trial ID | NCT07098728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 1 month to 12 years with prolonged convulsive seizures that persist after two bolus doses of benzodiazepines and who meet the study's inclusion/exclusion criteria are the ideal candidates.
✕Probably not a fit
Children with acute symptomatic seizures from hypertensive encephalopathy or hypoglycaemia, those with arrhythmia or respiratory depression, known chronic kidney or liver disease, or who already received non‑benzodiazepine anticonvulsants are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized study enrolls children aged 1 month to 12 years at Yangon Children's Hospital who continue to have convulsive prolonged seizures after two bolus doses of benzodiazepines. After parental consent, participants are block-randomized to receive either IV levetiracetam 40 mg/kg (max 3000 mg) over 15 minutes or IV phenobarbital 20 mg/kg (max 1000 mg) over 20 minutes. Clinical history, seizure characteristics, and safety data are recorded and patients are monitored in the emergency department, ICU, and wards. The trial compares speed of seizure cessation and tolerability between the two second-line antiseizure medications.
Why it matters
Potential benefit: If successful, the results could help clinicians pick the faster-acting and better-tolerated second-line medicine for children whose seizures do not stop with benzodiazepines.
How similar studies have gone: Levetiracetam and phenobarbital have been compared in prior trials with mixed results, but strong pediatric-specific head-to-head evidence is limited, so this direct comparison addresses a known gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged between 1 month to 12 years with prolonged seizures who do not respond to any two bolus doses of benzodiazepines Exclusion Criteria: * Any of the following criteria will be excluded. 1. Children who receive anticonvulsant treatment other than benzodiazepines for the acute management of prolonged seizures 2. Acute symptomatic seizures due to hypertensive encephalopathy or hypoglycaemia 3. Presence of arrythmia or respiratory depression 4. Known case of chronic kidney disease or chronic liver disease
Where it's running
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Yangon Children's Hospital
Yangon, Yangon, Burma Recruiting -
Yangon Children's Hospital
Yangon, Yangon, Burma Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.