Actively Recruiting

Phase 3
Age: 18Years - 120Years
All Genders
NCT05263674

Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)

Led by University of Southern Denmark · Updated on 2026-05-04

140

Participants Needed

5

Research Sites

359 weeks

Total Duration

On this page

Sponsors

U

University of Southern Denmark

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

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)

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients older than 18 years
  • EEG-confirmed non-convulsive status epilepticus (NCSE) using Salzburg criteria
  • Have not responded to benzodiazepines and at least one second-line intravenous anti-seizure medication (Levetiracetam, Fosfenytoin, or Valproate)
  • Treatment followed Danish national neurological guidelines
Not Eligible

You will not qualify if you...

  • Epileptic status caused by acute neuroinfections such as bacterial meningitis or viral encephalitis
  • Acute traumatic or spontaneous intracranial hemorrhage
  • Suspected cerebral anoxia, hypoxia, hypoglycemia, or epileptic encephalopathy
  • Contraindications to anti-seizure medications per protocol
  • Contraindications to anesthesia in intensive care
  • Focal motor status epilepticus without significant consciousness impairment (Glasgow Coma Scale above 13)
  • Known epileptic encephalopathy
  • Clinical need for immediate intubation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Aarhus Universitetshospital

Aarhus, Denmark, 8200

Actively Recruiting

2

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

3

Department of Neurology

Herlev, Denmark, 2730

Actively Recruiting

4

Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

5

University Hospital of Zealand

Roskilde, Denmark, 4000

Actively Recruiting

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Research Team

C

Christoph P. Beier, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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