Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)
Recruiting now · Phase 3
Conditions studied: Non-Convulsive Status Epilepticus
In brief
This open-label, randomized multicenter trial aims at clarifying the standard of care of patients with non-convulsive status epilepticus not responding to treatment with benzodiazepines and at least one high-dose intra venous anti-seizure medication.
Key facts
- Study ID
- NCT05263674
- Run by
- University of Southern Denmark
- People needed
- 140
- Starts
- 2022-02-07
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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 is running
- Aarhus Universitetshospital — Aarhus, Denmark (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Department of Neurology — Herlev, Denmark (enrolling)
- Odense University Hospital — Odense, Denmark (enrolling)
- University Hospital of Zealand — Roskilde, Denmark (enrolling)
Full record on ClinicalTrials.gov
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