Comparing fast sedation to high-dose anti-seizure medication for non-convulsive status epilepticus
Official title: Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)
Run by University of Southern Denmark · NCT05263674 · Data updated 2026-11-12
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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 5 sites (Aarhus and 4 other locations) |
| Status | Recruiting |
| Started | February 7, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT05263674 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years with EEG-verified non-convulsive status epilepticus who have not responded to benzodiazepines and at least one second-line intravenous anti-seizure medication.
✕Probably not a fit
Patients with acute neuroinfection, intracranial hemorrhage, or other specific contraindications to the treatments will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, randomized multicenter trial investigates the treatment options for patients suffering from non-convulsive status epilepticus (NCSE) who do not respond to standard therapies. Participants will be randomized into two groups: one receiving rapid sedation at intensive care and the other receiving high-dose intravenous anti-seizure medication. The study aims to clarify which approach is more effective in controlling seizures and improving patient outcomes. The trial will include adult patients with EEG-verified NCSE and will assess treatment efficacy based on clinical parameters.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment protocol for patients with non-convulsive status epilepticus, potentially reducing mortality rates.
How similar studies have gone: While there is limited evidence-based guidance for treating non-convulsive status epilepticus, this approach is novel and aims to clarify treatment strategies that have not been rigorously tested in a randomized setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (older than 18 years) with EEG-verified NCSE, according to the Salzburg criteria, who have not responded to appropriate treatment with benzodiazepines and at least one 2nd line i.v. anti-seizure medication according to the current Danish national neurological treatment guidelines (Levetiracetam, Fosfenytoin or Valproate). Exclusion Criteria: * patients with epilepticus status due to acute neuroinfection (e.g. bacterial meningitis or viral encephalitis) * acute traumatic or spontaneous intracranial hemorrhage * suspicion of cerebral anoxia / hypoxia / hypoglycemia / epileptic encephalopathy * contraindications to anti-seizure medication defined in the protocol * contraindications to anesthesia treatment in intensive care * focal motor status epilepticus without relevant conscious influence (Glasgow Coma Scale\> 13) * known epileptic encephalopathy * Clinical need for acute intubation
Where it's running
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Aarhus Universitetshospital
Aarhus, Denmark Recruiting -
Rigshospitalet
Copenhagen, Denmark Recruiting -
Department of Neurology
Herlev, Denmark Recruiting -
Odense University Hospital
Odense, Denmark Recruiting -
University Hospital of Zealand
Roskilde, Denmark Recruiting
Study contacts
- Study coordinator: Christoph P. Beier, M.D.
- Email: cbeier@health.sdu.dk
- Phone: +4565411943
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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Ketamine plus levetiracetam versus levetiracetam alone to stop prolonged generalized seizures in children
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.
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.