Ketamine plus levetiracetam versus levetiracetam alone to stop prolonged generalized seizures in children
Official title: Efficacy of Combined Ketamine and Levetiracetam as a Second-line Anti-seizure Medication for Generalized Convulsive Status Epilepticus in Children
Run by Sohag University · NCT07046611 · Data updated 2026-11-12
This trial will try giving ketamine together with levetiracetam versus levetiracetam with placebo to stop benzodiazepine‑refractory generalized convulsive status epilepticus in children aged 1–16 years.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 16 Years |
| Sex | All |
| Enrollment | 124 (estimated) |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Status | Recruiting |
| Started | July 2, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT07046611 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children 1–16 years old with clinically observed generalized tonic‑clonic seizures lasting longer than 5 minutes that continue or recur after an adequate benzodiazepine dose (last dose given 5–30 minutes earlier) and who have IV access are ideal candidates.
✕Probably not a fit
Children with acute traumatic brain injury, post‑anoxic or cardiac‑arrest seizures, significant hypo‑ or hyperglycemia, prior treatment with second‑line antiseizure drugs for this episode, prior endotracheal intubation, or known allergy/contraindication to ketamine or levetiracetam would not be eligible and are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children aged 1–16 who present to the emergency department with generalized convulsive status epilepticus that continues after adequate benzodiazepine dosing will receive either ketamine plus levetiracetam or levetiracetam with placebo as second‑line intravenous therapy. Treatments are administered acutely in the hospital setting and outcomes focus on termination of convulsive activity and short‑term clinical course. The protocol excludes patients previously treated with non‑benzodiazepine antiseizure medications for the current episode, those already intubated, and specific acute medical conditions such as traumatic brain injury or post‑anoxic seizures. Data from this study will compare seizure control rates and immediate safety between the combination and standard therapy.
Why it matters
Potential benefit: If successful, early combination therapy could stop ongoing seizures faster, lowering the risk of brain injury and long‑term neurological problems.
How similar studies have gone: Observational series and recent adult and pediatric reports have suggested ketamine can terminate refractory status epilepticus, but randomized pediatric data on early ketamine plus levetiracetam remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 1 year to 16 years. * Generalized convulsive status epilepticus (GCSE), defined as clinically observed generalized tonic-clonic convulsions that continue or recur without complete regaining of consciousness in between for longer than 5 minutes. * Benzodiazepine-refractory, defined as continuous or recurrent GCSE in the emergency room after receiving an adequate benzodiazepine dose, with the last dose administered within 5 to 30 minutes. Exclusion Criteria: * Failure to obtain informed consent. * Prior treatment with antiseizure medication or anticonvulsant sedatives other than benzodiazepines for the presenting GCSE episode. * Endotracheal intubation before enrollment. * Acute traumatic brain injury. * Cardiac arrest/post-anoxic seizures * Hypoglycemia or hyperglycemia. * Known allergies or contraindications to ketamine or levetiracetam * Failure to obtain intravenous access.
Where it's running
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Department of Pediatrics at Sohag University Hospital
Sohag, Egypt Recruiting
Study contacts
- Study coordinator: Elsayed Abdelkreem, MD, PhD
- Email: d.elsayedmohammed@med.sohag.edu.eg
- Phone: 1114232126
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Early prehospital ketamine plus midazolam for convulsive status epilepticus in children with epilepsy
This trial will test whether giving ketamine in addition to a second dose of midazolam before hospital arrival can stop convulsive status epilepticus in children with epilepsy ages 2–16.
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Comparing fast sedation to high-dose anti-seizure medication for non-convulsive status epilepticus
This study is testing whether quick sedation or high-dose anti-seizure medication works better for adults with non-convulsive status epilepticus who haven’t responded to regular treatments.
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.