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New treatment option 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)
ClinicalTrials.gov ID: NCT05263674
What this study is testing
What is Rapid sedation?
Rapid sedation is an investigational medicine, being studied as a potential treatment for non-convulsive status epilepticus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Adult patients (older than 18 years) with EEG-verified NCSE, according to the Salzburg criteria, who have not responded to appropriate treatment with...
You likely can't join 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)
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Copenhagen, Denmark
- Herlev, Denmark
- Odense, Denmark
- Roskilde, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Copenhagen, Denmark; Herlev, Denmark; Odense, Denmark; Roskilde, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.