Comparing fast sedation to high-dose anti-seizure medication for non-convulsive status epilepticus
Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)
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 |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 5 sites (Aarhus and 4 other locations) |
| Trial ID | NCT05263674 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with acute neuroinfection, intracranial hemorrhage, or other specific contraindications to the treatments will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aarhus and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.