Non-Convulsive Status EpilepticusPhase 3FASTNCT05263674
Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)
A Phase 3 study testing Rapid sedation in people with Non-Convulsive Status Epilepticus, run by University of Southern Denmark at 5 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Non-Convulsive Status Epilepticus
- What is being tested?
- Rapid sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesDenmark
- Study dates
- 7 Feb 2022to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aarhus Universitetshospital
Aarhus, 8200
Jakob Christensen, M.D., Ph.d.
- Recruiting
Rigshospitalet
Copenhagen, 2100
Anette S. Sidaros, M.D., Ph.d.
- Recruiting
Department of Neurology
Herlev, 2730
Anders Hougaard, M.D., +45 38 68 38 68, anders.hougaard@regionh.dk
- Recruiting
Odense University Hospital
Odense, 5000
Christoph Beier, M.D., cbeier@health.sdu.dk
- Recruiting
University Hospital of Zealand
Roskilde, 4000
Henning P. Hansen, M.D. Ph.D.
About this study
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.
Read the detailed description
Persistent epileptic seizures, aka. status epilepticus (SE), are the second most common neurological cause of acute admissions. Around halv of the patients suffers from SE without prominent visible seizures ("convulsions"), which is referred to as non-convulsive status epilepticus (NCSE) and is afflicted with a long-term mortality of >50% also in patients without concomittant acute brain disease. There are no evidence-based treatment guidelines for NCSE but patients usually receive treatment with benzodiazepines followed by i.v. anti-seizure medication. If seizures continues, further treatment is controversial. The participating centers have long-standing experience in treating NCSE but use different, internationally accepted treatment strategies. Some initiate aggressive treatment with fast sedation at intensive care aiming at immediate seizure control, other estimate that the side effects of sediation does not outweigh the potential benefit and try high-dose i.v. anti-seizure medication that only slightly impair conciousness - often with success.
This randomized, open label, multicenter trial (Eudract 2021-003392-34) aims at clarifying the treatment of patients with NSCE not responding to standard therapy. Patients with verified NCSE based on clinical parameter or using electroencephalography (EEG) are randomized into a fast acute sedation group and a group that receives at least one additional, high-dose anti-seizure mediciation.
Primary objective endpoint is treatment failure 24 h after randomization as determined by EEG. Secondary endpoints are e.g. seizure-induced neurological damage, treatment-related complications and neurological long-term outcome.
The statistical planing aims at showing superiority of aggressive treatment, 140 patients shall be included in a three years period at the University Hospitals in Aarhus, Odense, Roskilde and Copenhagen.
- Conditions
- Non-Convulsive Status Epilepticus
- Being tested
- Rapid sedation
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid sedationDrug
High-dose Propofol (bolus 3-5 g / kg, maintenance dose 5-10 mg / kg / hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg / kg / h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone.
| Study group | Role | What they receive |
|---|---|---|
| "Non-sedative medical treatment" | No intervention | The patient is treated with an additional high-dose intravenous antiepileptic drug, which is selected by the treating neurologist. If NCSE continues to be detected at cEEG or clinically> 3 hours after starting treatment, the patient should receive standard treatment (i.e. sedation in the intensive care unit or addition of additional intravenous antiepileptic drugs) in accordance with local guidelines and the assessment of the treating neurologist. The following preparations are permitted as additional treatment: Levetiracetam (60 mg / kg as saturation dose followed by maintenance dose of 2-4 g / day), valproate (60 mg / kg as saturation dose followed by maintenance dose of 20 mg / kg / day), phosphenytoin (20 PE as saturation dose followed by maintenance dose 5 mg PE / kg / day), lacosamide (400 mg as a saturation dose followed by a maintenance dose of 200-400 mg / day), topiramate (200-400 mg per probe as a saturation dose followed by a maintenance dose of 200-400 mg / day). |
| Fast sedation | Experimental | Within a maximum of 60 minutes after the diagnosis of NCSE (EEG or clinical), the patient must be sedated with high-dose Propofol (bolus 3-5 g / kg, maintenance dose 5-10 mg / kg / hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg / kg / h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone. After 20 hours, the sedation should be completely phased out within 3 hours. Receives: Drug: Rapid sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with continued NCSE on EEG after 24 h ("treatment failure")
NCSE diagnosed using EEG and defined by the "Salzburg criteria" for NCSE (e.g. Leitinger et al. Lancet Neurology, 2016)
Measured: 24 hours after randomisation
Secondary outcomes (2)
Number of treatment related complications
e.g. tracheostoma, infections
Measured: at discharge, on average after 7 days
New neurological deficit
Neurological deficits are quantified using National Institute of Health Stroke Scale (NIHSS, maximum possible score is 42, the minimum score - indicating no deficits - is 0) at admission and discharge. New neurological deficit is defined as increase of NIHSS >5 at discharge
Measured: at discharge, on average after 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start7 Feb 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Convulsive Status EpilepticusStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two treatment strategies
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University Hospital of Zealand, Copenhagen University Hospital, Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263674
- Sponsor's protocol ID
- 21/34684
- Other IDs
- 2021-003392-34
- Acronym
- FAST
- Status last verified
- May 2026
- First submitted
- 17 Jan 2022
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized IPD will be shared upon reasonable request within the limits of Danish legislation for data security.
Publications
Cornwall CD, Piilgaard H, Engedal TS, Olsen HT, Moller K, Kroigard T, Uslu B, Christensen J, Sidaros A, Beier CP. Fast Acute Sedation at Intensive Care vs. High-Dose IV Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus: A Randomized, Multicenter Trial. Crit Care Explor. 2025 Sep 15;7(9):e1311. doi: 10.1097/CCE.0000000000001311. eCollection 2025 Sep 1.
PubMed 40953286
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- FAST / 21/34684
- Conditions
- Non-Convulsive Status Epilepticus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University Hospital of Zealand, Copenhagen University Hospital, Denmark
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Persistent epileptic seizures, aka. status epilepticus (SE), are the second most common neurological cause of acute admissions. Around halv of the patients suffers from SE without prominent visible seizures ("convulsions"), which is referred to as non-convulsive status epilepticus (NCSE) and is afflicted with a long-term mortality of >50% also in patients without concomittant acute brain disease. There are no evidence-based treatment guidelines for NCSE but patients usually receive treatment with benzodiazepines followed by i.v. anti-seizure medication. If seizures continues, further treatment is controversial. The participating centers have long-standing experience in treating NCSE but use different, internationally accepted treatment strategies. Some initiate aggressive treatment with fast sedation at intensive care aiming at immediate seizure control, other estimate that the side effects of sediation does not outweigh the potential benefit and try high-dose i.v. anti-seizure medication that only slightly impair conciousness - often with success.
This randomized, open label, multicenter trial (Eudract 2021-003392-34) aims at clarifying the treatment of patients with NSCE not responding to standard therapy. Patients with verified NCSE based on clinical parameter or using electroencephalography (EEG) are randomized into a fast acute sedation group and a group that receives at least one additional, high-dose anti-seizure mediciation.
Primary objective endpoint is treatment failure 24 h after randomization as determined by EEG. Secondary endpoints are e.g. seizure-induced neurological damage, treatment-related complications and neurological long-term outcome.
The statistical planing aims at showing superiority of aggressive treatment, 140 patients shall be included in a three years period at the University Hospitals in Aarhus, Odense, Roskilde and Copenhagen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of two treatment strategies
| Arm | Type | Receives |
|---|---|---|
| "Non-sedative medical treatment" | No intervention | –The patient is treated with an additional high-dose intravenous antiepileptic drug, which is selected by the treating neurologist. If NCSE continues to be detected at cEEG or clinically> 3 hours after starting treatment, the patient should receive standard treatment (i.e. sedation in the intensive care unit or addition of additional intravenous antiepileptic drugs) in accordance with local guidelines and the assessment of the treating neurologist. The following preparations are permitted as additional treatment: Levetiracetam (60 mg / kg as saturation dose followed by maintenance dose of 2-4 g / day), valproate (60 mg / kg as saturation dose followed by maintenance dose of 20 mg / kg / day), phosphenytoin (20 PE as saturation dose followed by maintenance dose 5 mg PE / kg / day), lacosamide (400 mg as a saturation dose followed by a maintenance dose of 200-400 mg / day), topiramate (200-400 mg per probe as a saturation dose followed by a maintenance dose of 200-400 mg / day). |
| Fast sedation | Experimental | Drug: Rapid sedationWithin a maximum of 60 minutes after the diagnosis of NCSE (EEG or clinical), the patient must be sedated with high-dose Propofol (bolus 3-5 g / kg, maintenance dose 5-10 mg / kg / hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg / kg / h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone. After 20 hours, the sedation should be completely phased out within 3 hours. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid sedationHigh-dose Propofol (bolus 3-5 g / kg, maintenance dose 5-10 mg / kg / hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg / kg / h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone. | Drug | Fast sedation |
Primary outcome
Proportion of patients with continued NCSE on EEG after 24 h ("treatment failure")
Time frame: 24 hours after randomisation
NCSE diagnosed using EEG and defined by the "Salzburg criteria" for NCSE (e.g. Leitinger et al. Lancet Neurology, 2016)
2 secondary outcomes
Number of treatment related complications
Time frame: at discharge, on average after 7 days
New neurological deficit
Time frame: at discharge, on average after 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 40953286Cornwall CD, Piilgaard H, Engedal TS, Olsen HT, Moller K, Kroigard T, Uslu B, Christensen J, Sidaros A, Beier CP. Fast Acute Sedation at Intensive Care vs. High-Dose IV Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus: A Randomized, Multicenter Trial. Crit Care Explor. 2025 Sep 15;7(9):e1311. doi: 10.1097/CCE.0000000000001311. eCollection 2025 Sep 1.
- Individual participant dataSharing planned: No. Anonymized IPD will be shared upon reasonable request within the limits of Danish legislation for data security.
Related trials for Non-Convulsive Status Epilepticus
Recruiting
The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus
Status Epilepticus, Ictal-interictal Continuum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rapid sedation in people with Non-Convulsive Status Epilepticus, run by University of Southern Denmark at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoph P. Beier, M.D. (+4565411943, cbeier@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with continued NCSE on EEG after 24 h ("treatment failure") (time frame: 24 hours after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05263674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.